MassBio Careers

Sr. Analyst, Customer Insights

Tue, 21 May 2013 01:52:31 EDT

Position Summary:

The Senior Analyst, Customer Insights will be responsible for supporting (as described below) the generation of insights and influencing strategies/tactics to maximize brand value leading to actionable solutions that are customer-centric, relevant, meaningful and have business impact.

Responsibilities include:

Assess information/insight needs of internal customers (Brand leads / Product managers)
Articulate key business questions and testable hypotheses
Based on needs and business decision, identify research / analytical approach
Execute best in class primary market research by:
evaluating and optimizing research techniques to align with complexity of business question
ensuring that information from secondary data and other sources is systematically applied
ensuring that data & analytics are robust and answer the business questions
synthesizing findings and communicating actionable brand insights / recommendations
Analyze secondary data (e.g.: analysis of sales post entry of generic competitor using IMS sales data)
Create excel models to inform tactical ROI (e.g.: value of PME)
Communicate findings and recommendations to management

Note: This position is not available for Visa sponsorship. Candidate must be legally authorized to work in the United States for any employer without the need for sponsorship

Minimum Basic Qualifications:

Bachelors degree
5 years of pharmaceutical experience in a Commercial role or healthcare industry experience; relevant post graduate coursework may be counted toward experience
Demonstrated experience in developing a clear understanding of the customer and product dynamics and an ability to assimilate information quickly
Demonstrated ability to select and apply appropriate methods and techniques to analyze business issues
Experience constructing hypotheses, generating and analyzing data and providing recommendations based on meaningful conclusions
Strong excel and powerpoint presentation development skills
Must be authorized to work in the United States for any employer without the need for sponsorship

Preferred Qualifications and Experience:

BS, BEng, MBA
Degree in Market Research, Research Methodology or related field. MBA preferred.
At least 2 years of experience in a role that executed or utilized market research or a role that required interaction with hospital customers
Experience communicating insights in written and oral form in an impactful manner
Ability to manage research projects including vendor relationship, timelines and scope with internal customers

Competencies:

Demonstrated ability to understand the needs of the customer and tailor actions or communications to meet their needs
Proven ability to break down complex problems and gathering information in order to have a solid understanding of the problem
Demonstrable experience in leveraging the team (manager, peers, customers) as a resource to pull together a synthesized recommendation
Demonstrated commitment to achieving results and determining the path forward when faced with multiple priorities
Strong communication and interpersonal skills that support teamwork and inter-department partnerships

Work Environment:

Office setting

Physical Demands:

none

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position's essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Cubist is an Equal Opportunity Employer (EOE). M/F/D/V

Apply Here

Medical Writer/Editor

Tue, 21 May 2013 12:53:39 EDT

Title: Medical Writer/Editor

Reporting To: Director, Medical Writing

Infinity is an innovative drug discovery and development company seeking to discover, develop, and deliver to patients best-in-class medicines for difficult-to-treat diseases. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways. Infinity is a small but fully integrated drug discovery company with capabilities ranging from early discovery to clinical sciences.

Description:

Looking for a Medical Writer/Editor to support a three-person medical writing group responsible for clinical and nonclinical regulatory documents (such as study protocols, Investigator Brochures, Clinical Study Reports, Annual Reports, INDs, and NDAs) as well as clinical and nonclinical publications (including abstracts, posters, and manuscripts). This position will initially work across programs, ensuring all final documents meet with a high standard of consistency, accuracy, and clarity. In addition, this position will be responsible for maintaining the company’s reference library, currently maintained in Endnote®. This position has growth potential to take on lead writing responsibilities for one or more clinical studies currently under development.

Responsibilities:

Writes and/or edits clinical protocols, clinical study reports, investigator’s brochures, annual reports and other regulatory documents in conjunction with the project team with minimal supervision
Assumes primary responsibility for driving the clinical study report writing process, and other clinical document deliverables as appropriate
Develops and maintains timelines for document generation, revision, and completion, with minimal supervision
Prepares documents, coordinates and manages review cycles, incorporates comments, and leads discussions on document finalization with minimal supervision
Manages contracted writing projects with minimal supervision
Assists in the development and maintenance of SOPs and writing tools, such as templates and style manuals
Contributes to the development of electronic document systems and tools
Assists in the development of medical writing materials for within department and across department training
Prepares, reviews, and/or edits medical communications documents (manuscripts, abstracts, poster presentations, etc.) with minimal supervision
Provides quality control (QC) review of various regulatory and medical communications documents
Provides project team with technical guidance and problem resolution related to writing, templates, and MS WORD usage
Exercises judgment within broadly defined practices and policies in the writing of clinical documents
Recognizes problems, considers the significance of irregularities, and optimizes results by initiating preventative action
Acts as an authoritative resource for a specialty area to internal and external resources
Works effectively with other citizen-owners from other departments in team situations
Initiates collaboration with others and effectively represents inter-departmental project teams
Demonstrates ability to provide training on medical writing templates, SOPs, and processes within the department and across departments

Requirements:

BS/BA, MS/MPH/MA, or PhD in a scientific or medical discipline or equivalent with a minimum of 2 years of medical writing/editing experience in the pharmaceutical/biotechnology industry or CRO environment.
Ability for different types of clinical and regulatory documents as well as the ability to understand and summarize clinical data.
Expertise in MS WORD, including the ability to solve technical problems with documents and templates
Knowledge of FDA and ICH guidelines
Excellent grammatical and communication skills, both written and oral
Basic knowledge of science and clinical research
High level of professional expertise through familiarity of industry trends for clinical documents and international dossier preparation, including electronic document submissions
Experience working on complex projects, within cross-functional teams

To apply please visit our website: www.infi.com/careers-opportunities.asp

Web and Graphics Specialist

Tue, 21 May 2013 11:02:41 EDT

Position Description

Web and Graphics Specialist

Seahorse is the leader in measuring cellular metabolism and our award-winning XF Analyzers are fueling the rapid growth in the research and drug discovery markets. We are looking for a creative and talented individual who will be responsible for administering our website and for designing a wide range of print and web marketing materials that promote and support the Seahorse brand.

Position Summary

The Web and Graphics Specialist will work closely with the other members of the Marketing team to build and maintain a robust Seahorse website and to develop visual elements that drive project and campaign success. The ideal candidate should have a creative and imaginative approach to design and must be organized and self-motivated.

Key Responsibilities:

Keep web content current by creating/updating using HTML, CSS, PHP, jQuery, SQL
Issue HTML email blasts and on-line-marketing programs
Manage webinar, customer lead, and e-commerce interfaces
Report monthly web stats utilizing Google analytics or similar
Implement site enhancements and add capabilities
Create and optimize graphics for web pages, banners, print ads, sales collaterals, brochures, posters, packaging, and other marketing materials
Manage the marketing document control system
Manage relationships with web and graphics vendors/subcontractors
Coordinate with marketing team to create content, update/maintain accuracy of content
Adhere to Seahorse brand guidelines
Assist in assessing program effectiveness/ROI

Key Qualifications

BA or BS in design and/or development
Experience with HTML, CSS, PHP, jQuery, mySQL, Photoshop, Dreamweaver, Illustrator, InDesign (Adobe CS6)
Working knowledge of Office software
Excellent writing and verbal communication skills
Ability to manage multiple projects and initiatives at once, on deadline, within budget
Ability to work independently
Ability to manage external vendor and contract relationships
1-2 years web-based marketing experience
1-2 years design experience
Comfortable working in a matrix environment
Experience in biotech and start-up experience a plus
Familiarity with salesforce.com and google analytics a plus

Contract Senior Drug Safety Specialist

Tue, 21 May 2013 10:02:57 EDT

The Sr. Global Drug Safety/Pharmacovigilance Specialist will be responsible for all aspects of adverse event report receipt, assessment, tracking and distribution activities including submission of expedited reports from all sources, as well as narratives writing and follow-up. The incumbent will oversee aspects of adverse event processing with Contract Research Organizations (CROs), while also assisting management in establishing and implementing departmental strategy, working in close collaboration with business partners (Regulatory, QA, Medical) as well, CROs.

Responsibilities:

Receive, track and assess SAE report from all sources
Independently evaluate case source, SAE and patient information to determine report status (initial vs. follow-up), expedited, not expedited
Assess SAE reports for completeness and enter all applicable data into the safety database including medical history, suspect/concomitant drugs, report source and patient demographics
Communicate with the clinical sites/CRAs for additional information
Code medical events, medical history and concomitant medications using MedDRA and WHO Drug
Work closely with the medical monitors: review expectedness, relationship, required follow-up, draft event narrative
Participate in the SAE reconciliation with clinical database.
Ensure all FDA and international drug safety reporting regulations and procedures are followed
Collaborate with contract research organizations providing drug safety services for ongoing clinical trials
Assist with the development of SOPs/work instructions as needed
Assist in the updating of investigators brochures and annual reports as needed
Participate in the creation and/or improvement of departmental processes to improve process efficiencies
Assist with protocol and CSR development as needed
Provide input to interdisciplinary teams on drug safety reporting for company sponsored and investigator sponsored clinical trials

Qualifications:

RN/ PharmD with at least 3- 5 years of Drug Safety Experience
Experience with data entry into safety database(s) (eg, Clintrace, Argus) and coding (MedDRA and WHODrug)
Working knowledge of ICH, European Commission, and FDA Guidelines and Regulations pertaining to Adverse Event Reporting
Prior experience in pre-approval and/or post-marketing experience in a global environment is desirable
Oncology Safety experience preferred
Working knowledge of overall drug development process
Effective written and verbal skills
Excellent attention to detail and effective organizational skills
Critical thinking and problem-solving skills
Ability to manage multiple tasks with deadlines
Work well in a fast-paced, team environment
Experience working with 3rd party vendors for outsourced safety functions preferred

Click here to apply:

Front Desk Receptionist

Tue, 21 May 2013 08:46:39 EDT

The front desk receptionist will be responsible for the greeting of guests in a pleasant, professional and welcoming manner. This position will ensure that all visitors are promptly announced and escorted to the designated meeting location. Several other responsibilities will include:

Provide phone coverage to main phone line. Answering, screening, and routing incoming telephone inquiries with professional telephone etiquette.

Distribute mail, receive packages, and coordinate all outgoing shipments and deliveries for Lexington office.
Function as a team member using good judgment and initiative. Self motivated, positive and able to communicate needs effectively with management and visitors.
Enforcing visitor registration policies and procedures with badge identification for all Synageva employees, contractors, and non-employees.
Perform other ad hoc projects to support the management team, such as:
- Research and prepare travel itineraries.
- Act as a liaison between Lexington, MA and Athens, GA offices.
- Maintain office supply inventory.
- Ensure neat appearance of reception area.
- Responsible for conference room scheduling, as well as preparing and setting up for meetings, as needed.

Support miscellaneous office functions including processing financial paperwork.

2-4 years reception/administrative experience, preferably in a scientific environment.

Strong PC skills with expertise in Outlook, Word, Excel and PowerPoint.
Professional attitude, appearance and demeanor.
Must be able to respond to variable workflow and maintain composure in a sometimes high-pressure environment.
Well organized and detail oriented. Proven ability to work independently and able to keep on top of multiple priorities.
Regular, reliable attendance and punctuality. Flexibility to come in early or stay late on short notice, if requested.
Excellent verbal and written communication skills.
Capable of positively representing Synageva.

Ability to maintain confidentiality.

Sr. Director, Physician Safety Head

Tue, 21 May 2013 02:43:53 EDT

GENERAL POSITION SUMMARY:
Reporting directly to the Head of Global Patient Safety, the Disease-Area Safety Head (Physician) will lead all safety and benefit-risk related activities for products within their Disease-area and/or Franchise, including pre-franchise products from first in-human clinical trials, into and throughout commercialization.

GENERAL RESPONSIBILITIES AND REQUIRED SKILLS
As a member of the Senior GPS Leadership Team, they will assist in ensuring consistency of safety assessment, analysis and reporting for all designated product(s) throughout Vertex’s world markets. Each Disease-area Safety Head will also lead the development of the pre-marketing risk assignment and for oversight of the planning and execution of Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) for regulatory authority submissions and post-marketing requirements. S/he will work closely with the program specific Clinical Research Physicians and their Teams, Medical Affairs leaders and their teams, and Partners (as applicable) to proactively assess and address potential and identified safety issues for each product throughout the product life cycle.

KEY RESPONSIBILITIES:
-   Provide leadership and oversight of Disease-area Safety Team(s) for all products within assigned therapeutic area(s), including key benefit-risk assessment, providing strategy for DSTs to meet goals and objectives.
-   Coordinate and oversee the regular review of safety data for identification of new safety signals, in accordance with Vertex signal detection practices.
-   Collaborate with Clinical Leaders to develop and implement appropriate Risk Management procedures/plans for each product, both pre-approval and post-approval, as needed.
-   Collaborate with NDA teams assessment, strategy and execution of key Regulatory Authority documents in support of submissions, specifically leading development of any Risk Evaluation and Mitigation Strategy (REMS), Risk Management Plan (RMP) or equivalent documents.
-   Collaborate with GPS Epidemiology with regards to development, implementation and reporting of pharmacoepidemiology studies, as needed.
-   Review and/or assist in preparation of Developmental and/or Post-Marketing Periodic Safety Updates (D/PSURs), IND packages, as well as NDA and IND, MAA Annual Safety Reports.
-   Provide review and safety-specific input for labeling documents, including IB, CCDS, USPI, SmPC and other local labels, as applicable.
-   Collaborate with Regulatory Affairs to develop responses to any safety related regulatory agency inquiries.
-   Provide and oversee medical review of aggregate and/or individual post-marketing and clinical trial adverse event reports, in accordance with GPS review practices.
-   Conduct medical evaluation of other relevant non-AE/SAE related safety information, such as from Toxicology, Non-Clinical studies and Product Quality sources.
-   Review and provide oversight for medical content for key study-related documents, e.g., Protocols, Statistical Analysis Plan, IB, ICF and IDMC Charter.
-   Review and provide oversight in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports.
-   Review and provide oversight of safety sections of clinical study reports.
-   Provide a contributory role in Partner /Affiliate agreements and interactions, as needed.
-   Participate/serve as Subject Matter Expert in departmental development activities including SOP and Work Instructions development.
-   Provide guidance to Medical staff and liaise with Operations leads regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective.
-   Provide guidance to direct reports, regarding the scope of GPS Physician responsibilities, and the provision of sound medical input for all pre-marketing and post-marketing activities.
-   Facilitate the growth and development of staff and direct reports.

Minimum Qualifications:
-   Solid knowledge of General Medicine, including a doctorate in Medicine (M.D.) or equivalent.
-   Extensive knowledge of GCP, ICH and Global regulations.
-   At least 5 years Pharmacovigilance experience

Preferred Qualifications:
-   Strong people management skills
-   Strong leadership skills with the ability to communicate effectively in a matrix environment.
-   Experienced in the critical evaluation and interpretation of data, with ability to synthesize into clear, coherent messaging.
-   Solid knowledge of Benefit-Risk strategies and decision-making
-   Ability to multi-task, adeptly handling multiple demands.

Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist. For more information and to view Vertex's press releases, please visit www.vrtx.com.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

To Apply for this position, please CLICK HERE

Quality Control Specialist - Biochemistry

Tue, 21 May 2013 12:00:00 EDT

Merrimack Pharmaceuticals is a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of serious diseases, with an initial focus on cancer. Merrimack applies Network Biology, its proprietary systems biology-based approach to biomedical research, throughout the research and development process. Merrimack currently has six targeted therapeutic oncology candidates in clinical development.

Job Responsibilities:
As a Quality Control Specialist, you will perform product release and stability testing, and act as a lead in the development, optimization, qualification and/or validation of analytical methods used for the analysis of protein and liposomal drugs. These activities will support a wide range of products from pre-clinical and IND-enabling CMC activities to late-stage clinical and commercial testing. You will also be responsible for assisting in the implementation of part 11 compliant software and other electronic systems into the QC lab.

Requirements:
The position requires a BS or MS in biochemistry or a related field and 5+ years of experience. The candidate should have an established track record in performing HPLC-based assays for proteins, lipids, and/or small molecules under cGMP. The candidate is expected to be knowledgeable in most or all of the following techniques: Particle Size, Peptide Map, Reverse Phase, SEC, CEX, SDS-PAGE, Bioanalyzer, pH, Osmolality and other standard wet chemistry methods. The candidate should have excellent team skills, effective organization and presentation skills; be reliable, motivated, and have strong interpersonal communication skills (written and verbal) amenable to work in a team environment. It is expected that the quality control specialist is able work independently; design method development experiments, and write validation protocols and reports. The specialist will present data in team meetings and act as a lead on multiple projects within the QC lab.

If you are interested in a great opportunity with a fantastic company, please click the link to apply:

http://hire.jobvite.com/j/?cj=oDhsXfw3&s=Mass_Biotech_Council

Director, Pharmacovigilance and Risk Management

Tue, 21 May 2013 12:00:00 EDT

Develop pharmacovigilance long-term plan and infrastructure (systems, processes, SOP’s, etc.) to enable full compliance for both internal and partnered responsibilities
Perform clinical assessment of SAE cases reported from clinical trials; perform Sponsor causality assessment; determine regulatory reportability
Work closely with Merrimack colleagues in the proper gathering, evaluation, medical assessment and follow-up of individual case safety reports
Identify and analyze possible trends and concerns with company products including the identification and evaluation of safety signals through the assessment of single case safety reports, aggregate trend analyses and review of relevant literature for safety information pertinent to product safety
Perform review of adverse event, medical history and concomitant medication coding into WHO-Drug and MedDRA codes
Prepare/review aggregate safety reports for submission to domestic and international regulatory authorities
Contribute to and support development of evolving risk management plans
Prepare and maintain summary analyses of safety data on key events from all available sources including the literature
Accurately identify safety issues that require further evaluation and
Effectively collaborate with interdisciplinary team in the evaluation and management of safety issues during clinical development
Contribute to and support safety sections clinical investigator brochures, risk profiles, protocols, and regulatory reports (e.g. Annual IND report; 6-monthly line-listings; EU Annual Safety Report, DSUR)
Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.
Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the organization.

Requirements:

MD, PhD, or PharmD
Minimum of 2 years experience in the pharmaceutical, biotech, or contract research organization in Pharmacovigilance & Drug Safety or Pharmacoepidemiology.
Minimum of 1 year clinical experience in academic or private practice including hospital based setting.
Advanced knowledge in pre and post-marketing, US and international, safety regulations
Ability to formulate and lead and investigative plan as well as develop sound risk assessment
Advanced ability to analyze and interpret clinical data
Strong analytical skills
Ability to influence others (cross-functionally and within the function) to create a positive working environment
Experience in developing, executing RiskMaps/ Risk Management Plans
Strong commitment to business ethics
Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners
Passion for fighting cancer

If you are interested in a great opportunity with a fantastic company, please click the link below to apply:

http://hire.jobvite.com/j/?cj=oiy9XfwG&s=Mass_Biotech_Council

Sr. Pharmacovigilance Specialist (MB-3677)

Mon, 20 May 2013 05:34:14 EDT

Contract to Hire

Duties:

Will be responsible for reviewing Triage reports for initial assessment from clinical trials and post marking sources in accordance with local work instructions, US FDA regulations, and international guidelines and regulations with high level of accuracy.
Assist with data entry of incoming reports from clinical trials and post marketing sources in accordance with applicable regulations, company SOPs and applicable licensing agreements with high level of accuracy, accountability, and minimal supervision.
Perform active follow-up via verbal or written contact with healthcare professionals and consumers.

Background:

A clinical degree (Pharm. D., RN, etc.) is required
Must have 3+ years Pharmacovigilance experience within the biopharmaceutical industry.
Must have experience reviewing Triage reports.

Candidates must live local and be a US Citizen or Green Card Holder

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.

www.cwsciences.com

Research Associate – Formulations

Mon, 20 May 2013 05:21:05 EDT

Research Associate – Formulations

Responsibilities:

Support formulation, process development & optimization. Specific methods may include bench and pilot-scale spray drying
Characterize bulk and flow properties of powder formulations using powder rheometry
Perform testing of solid-based inhalation dosage forms for characterization of physical and aerosol properties. Specific methods may include laser diffraction and cascade impaction
Support batch manufacture for development, pre-clinical and clinical studies

Education

BS Chem Eng, Biomed Eng, Mat Science, or related field
0-5 years of experience in biotech/pharmaceutical R&D

Contract - Immediate Need

QA Documentation Coordinator

Mon, 20 May 2013 05:17:01 EDT

We are seeking a QA Documentation Coordinatorto assist in the review and revision of procedures, specifications and forms, and in maintaining computerized files to support all documentation systems.

Duties & Responsibilities:

Participate in the operation and maintenance of the electronic documentation system for controlled issue and retrieval of approved CGMP documents
Perform workflow management of document changes in the electronic documentation system
Perform technical editing and word processing on document changes
Maintain physical archive information locations through filing, scanning and documenting movement to and from archivesMaintain controlled access to archive storage
Provide assistance to site personnel to ensure documentation requirements are effectively communicated, understood and met, and that the governing procedures are followed
Participate in the Documentation Room operations during regulatory inspections of the site
Issues batch production records to manufacturing in a manner that permits control of issue and accountability for use and/or retrieval
Participate in the process for document distribution to manual locations

Requirements:

1 or more years in pharmaceutical QA documentation
0-2 years’ experience in pharmaceutical GMPs
MS Office skills (Outlook, Word, Excel and PowerPoint) required
Documentum experience a plus
Knowledge of administrative and clerical procedures and systems such as word processing, managing files and records, transcription, designing forms, and other procedures
Ability to communicate both verbally and in writing
Diligence with respect to record keeping and document accountability

Research Associate, Synthetic Chemistry Bio-conjugation

Mon, 20 May 2013 04:22:26 EDT

Our client is looking for a Research Associate to use their experience in the synthesis, purification and conjugation of small molecules and peptides. This position requires a BS or MS with 3 to 5 years of industry experience in the design and synthesis of small molecules and/or peptides. Additional experience includes: experience with HPLC, LC/MS and NMR and other common analytical techniques, experience in bio-conjugation and relevant biochemical methods is a plus (biotinylation, fluorescence, SEC, FPLC, SDS-PAGE), experience in SPR-Biacore, calorimetry, ELISA, FACS is highly desirable

Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

StratAcuity, CHEMISTRY IS EVERYTHING.

Manager, Quality Control

Mon, 20 May 2013 04:15:28 EDT

ImmunoGen, Inc. is seeking a Manager, of Quality Control to manage the chemistry and raw materials groups out of our Norwood facility. The successful candidate will continuously improve on quality control systems and provide support to manufacturing and facilities, while working in compliance with ImmunoGen’s quality policies and cGMP requirements. This candidate will also contribute to the overall achievement of department and corporate goals.

Job responsibilities include but not limited to the following:

Manage QC raw material staff: Provide guidance, career development to direct reports
Develop individual goals
Provide support to budget development and monitoring for areas of responsibility
Ensure appropriate identification, selection and oversight of contract test labs
Develop analyses for in house testing versus outsourced testing
Collaborate with analytical development groups, partners, CMOs & CTLs, as necessary
Ensure appropriate completion and review of routine QC documentation
Perform routine audits of Quality Control Systems as part of continuous improvement and preventive action
Lead investigations of Out-of-specification results
Monitors invalid-assay rate and identifies root cause and corrective action as, necessary
Maintains centralize testing schedule
Serve as the QC technical expert as it pertains to in-process, release and stability testing
Assist in writing / review of regulatory documents, reports
Works with QA unit and Inventory Control staff to support timely disposition of raw materials and intermediates

BS degree in biochemistry or in a related scientific field. Minimum of 8 years experience in pharmaceutical/biopharmaceutical quality control with at least 3 years in a supervisory role, or a minimum of 8 years experience in a testing laboratory with 5 years in a GMP environment and at least 3 years in a supervisory role. Experience applying phase appropriate (Phase I- III) QC policies and practice. Candidate must have the ability to work well in a cross-functional environment.

Candidate may be required to lift 30 lbs., working with hazardous chemicals up to Safe Bridge Level III. Also, candidate may be required on occasions to work extended hours and weekends. Some travel is required.

ImmunoGen, Inc. offers an excellent salary and benefits package including 100% paid health and dental insurance, 401(k) and tuition assistance. Please send a detailed resume to: Human Resources Department, ImmunoGen, Inc., 830 Winter Street, Waltham, MA 02451: Fax: 781-895-0611; E-mail: resumes@immunogen.com. Please reference the ad source in your response.

We are an Equal Opportunity Employer

Specialist, Clinical Risk Management

Mon, 20 May 2013 03:39:07 EDT

Position Summary:

This position works in a team oriented environment and will have the following primary responsibilities:

Serves as Pharmacovigilance CRM representative for assigned project/product team meetings
Responsible for weekly literature review and evaluation
Assists with preparing aggregate reports, the Risk Management Plan, and/or Risk Evaluation and Mitigation Strategies for assigned products
Performs routine assessment of safety signals and prioritization for full evaluation in conjunction with responsible CRM Safety physician.
Contributes to regulatory submissions (PSUR, ASR, IND annual, Agency requests, etc.)
Performs and documents vendor oversight activities (review of deliverables provided by vendors) including tracking of quality issues and escalation of safety or quality concerns
Assists with preparation of responses for inquiries from stakeholders for assigned products in conjunction with CRM physician
Assists with writing and maintaining standard operating procedures
Assists with preparing Reference Safety Information (US Package Insert, Investigators Brochure, Developmental Core Safety Information, Company Core Safety Information etc) for assigned products
Assists with developing standards and metrics for CRM activities
Works on/manage special projects as directed

Minimum Basic Qualifications

Minimum BS in a life science degree with previous experience in a healthcare setting
Minimum of 1 year experience in drug safety/Pharmacovigilance
Familiarity with regulatory safety reporting requirements and guidelines are required, including Good Clinical Practices (GCP).
Must be detail-oriented and have strong organizational and communication skills

Preferred Qualifications and Experience:

Experience with MedDRA coding and safety database systems strongly desired
Knowledge and/or experience with safety surveillance, signal detection, labeling analyses, and ad hoc safety analyses.
Experience in the reviews of relevant safety information from all sources and analysis of safety data.
Excellent interpersonal, communication, and personal organization skills.

Competencies:

Ability to focus on delivering excellent results and improving the performance of oneself and of Cubist by taking initiative to try new approaches for more effectiveness and efficiencies, while still following the rules (e.g., company, government and ethical), by taking action to surpass one's own past performance, excel at an objective measure or goal, or do something that has never been done before.
Ability to recognize opportunities and/or issues and apply analytical and creative thinking to maximize performance.
Ability to targeting one's efforts on discovering and meeting an internal or external customer's needs by ensuring timely follow through to customer inquiries or business issues, and being proactive in adding value to the customer.
Ability to demonstrate respect for others by seeking to understand how they think about issues and perceive problems and opportunities through actively listening and understanding the unspoken or partly expressed thoughts, feelings, and concerns of others.
Ability to work cooperatively with colleagues and take initiatives to build relationships despite differences in interest, offering support and help to peers without being asked or proactively seeking input from others to solve problems.
Ability to express ideas and information clearly and accurately.
Ability to work independently to accomplish individual and department objectives within deadlines.
Ability to work effectively as both a collaborative member of a team and as an individual contributor.
Ability to prioritize workload and work effectively, sometimes within resource constraints

Work Environment:

This is a Lexington-based position that requires significant interactions with internal colleagues from other departments and with external colleagues and consultants. Works within Cubist's established policies and procedures and ensures alignment of their work with Cubist's values.

Physical Demands:

Minimal travel may be required

*LI-CP

Apply Here

Manager - Scientific Writing/Editing Team

Mon, 20 May 2013 10:23:01 EDT

https://home.eease.adp.com/recruit/?id=5184501

Scientific Writer/Editor

Mon, 20 May 2013 09:36:09 EDT

https://home.eease.adp.com/recruit/?id=5151011

Pharmacovigilance Coordinator (329-419)

Mon, 20 May 2013 09:31:48 EDT

ARIAD is a Cambridge, Massachusetts-based biotechnology company focused on cancer. We are a cohesive team of talented people from diverse backgrounds with a shared vision: We seek to transform the lives of patients with breakthrough cancer medicines. This is our purpose. This is our passion. This is our promise.

The Pharmacovigilance Coordinator will be responsible for providing tactical support to efficient drug safety operations related to processing and reporting of serious adverse events (SAE) from clinical trials. Responsibilities Include:
Perform initial processing and tracking of SAEs under the direction of a Drug Safety Specialist Plan and maintain coordinated processes between PVG and other internal and/or external groups (e.g. CRO) for the timely and accurate transfer of files/data as required Perform SAE case closure activities Management and tracking of queries for clinical trial SAEs Assist in reconciliation activities including performing review of source data in SAE files and providing direction in the accurate generation of queries Create and maintain standard SAE queries for use during reconciliation of the clinical and safety databases Maintain holiday schedules to ensure all SAEs are handled in accordance with safety regulations and department procedures and communicate to internal/external groups as necessary Assist in the preparation of aggregate data for safety review sessions Create/maintain multiple tracking spreadsheets and routinely provide metrics/trending Assist in supporting audits/inspections; create and maintain audit-ready files including training files Perform other operational tasks in support of Safety Operations as required by Management Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners. Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the ARIAD organization
Job Requirements:
Bachelor’s degree in life sciences A minimum of 2 years prior experience in a supporting operational/tactical role Detail-oriented and persistent with excellent organizational skills Proficient with Microsoft Word, Excel Familiarity with medical terminology Prior experience with providing operational support in a regulated environment and/or knowledge of US/Global regulations governing adverse event reporting is desired Familiarity or prior experience in safety database or similar database is desired Strong commitment to business ethics Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners

Submitting a resume online at a job site could cause valuable screening information to be missed.
Click here to apply: http://ariad-openhire.silkroad.com/epostings/submit.cfm?fuseaction=app.dspjob&jobid=329&company_id=16419&jobboardid=306
ARIAD is an equal opportunity employer. The Company's policy is to afford equal employment opportunities to qualified individuals without regard to race, color, religion, national origin, ancestry, citizenship, marital status, veteran status, physical or mental disability, sex, sexual orientation or age and to comply with applicable laws and regulations. All employment decisions will be consistent with the principle of equal employment opportunity.

Manager - Medical Communications, Publications (328-419)

Mon, 20 May 2013 09:28:32 EDT

Summary The Manager, Medical Communications, will support strategic scientific planning and execution efforts and provide project management oversight for publication projects (abstracts, posters, oral presentations, and manuscripts) for assigned compounds or indications. The successful candidate will also write, edit and review publications and conference material and liaise with internal and external contributors to develop content. Prior scientific publications medical writing experience, ability to communicate data effectively, and excellent project management skills are essential; prior experience managing medical communication vendors is preferred. Duties and Responsibilities - Works with cross-functional, multidisciplinary teams to execute and manage strategic publication plans for ARIAD’s proprietary compounds. - Writes, edits, and reviews publications and conference materials as required, along with managing the review and submission process. - Manages medical communication vendor(s) as required. Builds and manages relationships with internal and external contributors to publications and conference material. - Responsible for ensuring the scientific integrity, quality, and accuracy of all deliverables within their remit. - Monitors and ensures compliance with Corporate and Departmental Policies and procedures, as well as external guidelines and regulatory bodies such as FDA and ICMJE guidelines, GPP2, and project-specific society or journal guidelines. - Maintains knowledge of product areas, current trends, and current literature. Requirements - Advanced scientific degree in the life sciences preferred (PhD, MD, or Pharm D) - 4+ years of relevant pharmaceutical or biotechnology industry experience required - Excellent ability to interpret and present scientific and clinical trial data to a variety of audiences, along with a strong understanding of statistics - Excellent writing skills coupled with a comprehensive knowledge of the publication process and publication guidelines, along with careful attention to detail - Strong leadership, planning and project management skills, along with initiative and the ability to be productive with minimal supervision - Demonstrated innovation and creativity in production of work products and methods to maximize data disclosure in a timely, appropriate and effective manner - Excellent interpersonal and communication skills, with the ability to work well both independently and as part of a team - Commitment to ethical practices in the preparation and dissemination of publications, including conference material - Proficient with computer software applications, in particular Microsoft Word, Microsoft Power Point, and EndNote software. Previous experience with Datavision is an advantage.

Submitting a resume online at a job site could cause valuable screening information to be missed.
Click here to apply: http://ariad-openhire.silkroad.com/epostings/submit.cfm?fuseaction=app.dspjob&jobid=328&company_id=16419&jobboardid=306
ARIAD is an equal opportunity employer. The Company's policy is to afford equal employment opportunities to qualified individuals without regard to race, color, religion, national origin, ancestry, citizenship, marital status, veteran status, physical or mental disability, sex, sexual orientation or age and to comply with applicable laws and regulations. All employment decisions will be consistent with the principle of equal employment opportunity.

Principal Scientist, Protein Purification [GBT]

Mon, 20 May 2013 02:33:56 EDT

To apply for this position, please CLICK HERE

Alliance Manager, Centers for Therapeutic Innovation [CTI]

Mon, 20 May 2013 02:27:30 EDT

Org Marketing Statement
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That’s why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.

Department Marketing Statement
The Centers for Therapeutic Innovation (CTI) unit is aimed at forging seamless, highly impactful ties between pharma and academia, thus enabling the accelerated translation of innovative findings to the clinic. Pfizer’s ambition is to bridge the gap between early science and clinical applications, by allowing investigators access to Pfizer’s extensive libraries and proprietary screening and antibody development technologies. In addition, academic collaborators will have the support of internal Pfizer scientists who can help match Pfizer resources to researcher needs.

CTI offers a differentiated approach, the incentives, operating model and goals of which are all designed to focus on achieving a positive Proof of Mechanism (PoM) study in humans.

Pfizer Centers for Therapeutic Innovation will consist of several laboratories which combine the xpertise and innovation of both Pfizer colleagues dedicated to a specific function, as well as approximately 20 post-docs assigned to sponsored programs.

This initiative represents a significant opportunity for leading academic investigators and institutions to enable the fast, efficient translation of novel, innovative science into clinical candidates, and – eventually – approved therapeutics. We believe that the combination of the operating, financial resource and scientific access modal partly described above will bring more and more novel programs to the clinic, ultimately creating significant benefit for the patient, for investigators and for institutions.

Responsibilities
The candidate will assist in the effective operations of CTI’s governance and structure ensuring that Joint Steering Committees between Pfizer and our academic partners run as efficiently as possible and the Pfizer CTI is viewed as a partner-of-choice by academic institutions. The candidate will be a point-person for several Pfizer-Academic joint steering committees, and t hus will have significant exposure to high-level academic leaders as well as senior Pfizer scientists.

Specifically, the candidate will be responsible for:
• Relationship management with academic medical centers – serving as a single point-of-contact for our academic partners as they work through issues of proposal submission, research operations, financial issues, and general problem-solving
• Joint Steering Committee Meeting Operations – working with joint steering committee members to schedule, plan for and attend quarterly meetings of steering committees at multiple academic institutions in the California area
• Liaison to Intellectual Property – managing the complex IP implications of CTI projects and contracts, work together with Pfizer IP attorneys and u niversity tech transfer office staff to ensure that all the necessary information is accurately captured to ensure protection of future Pfizer/university rights
• Institutional Marketing – working with local steering committee members and Pfizer scientists, design and execute marketing activities to increase the profile of CTI on local campuses and in the scientific communities in which we work. Includes refinement to CTI Portal, to enhance online engagement with CTI resources and more efficiently manage the proposal process
• Coordinate with Project & Portfolio Management Team – the candidate will work closely with CTI-s portfolio management team to ensure that the steering committee logistics are well-aligned with portfolio decision-making needs, including the oversight of a .multi-stakeholder proposal review process
• Liaison to Business Development – in addition to the responsibilities described above, the candidate occasionally coordinates with our business development and legal colleagues on contracts, ongoing negotiations and other partner-related matters.

The candidate will be expected to be a team player, with a demonstrated track record for working across large, complex organizations. This candidate will be a go-to resource for our most-valued external partners and will be expected to represent CTI and Pfizer with the utmost of integrity and professionalism.

Qualifications
1.Bachelor’s Degree required
2.3-5+ years in pharmaceutical biotech industry in one of various roles – scientist, project manager, junior marketer, operations professional, etc.
3.Good problem-solving skills – creative in finding solutions to difficult challenges
4.Strong communications skills and ability to influence others
5.Comfort working in a fast-paced and rapidly changing environment
6.Detail oriented with ability to manage multiple simultaneous projects

Equal Employment Opportunity

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Pfizer in the U.S. In certain circumstances it may be advantageous to Pfizer to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Pfizer and the specific job and/or work site. Pfizer may at its business

discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Pfizer in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Pfizer's support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Pfizer.

To apply for this position, please CLICK HERE

Oncology Sales Specialist - The Bronx

Mon, 20 May 2013 01:59:29 EDT

At Millennium: The Takeda Oncology Company; “We Aspire to Cure Cancer”. Millennium is a leading biopharmaceutical company focused on oncology that combines the agility, ideals and camaraderie of a start-up with the resources of Japan's largest pharmaceutical company. The result is a creative, entrepreneurial environment where quality science and making a difference in patients' lives are the priorities. Here, employees who share a drive and commitment to innovation for the benefit of oncology patients find their ideas, experience and contributions are valued and rewarded. Millennium offers great benefits, a friendly and respectful atmosphere, and a culture that promotes flexibility between work and life and encourages employees to give back to their community.

POSITION SUMMARY:
An Oncology Sales Specialist represents Millennium and implements the strategies that will result in the achievement of short and long term product and company objectives.

DUTIES & RESPONSIBILITIES:
The Sales Specialist will be recognized by customers, peers and managers as having expert knowledge of customers, oncology, VELCADE™ and other Millennium products and competitive products in the oncology field.

Responsibilities include, but are not limited to:
- Achievement of all assigned sales and company goals
- Development and implementation of territorial business plans
- Financial management of assigned territory
- Excellent use of marketing materials and programs
- Initiation of activities resulting in expanded business opportunities for Millennium
- Knowledgeable/professional presentation to customers
- Excellent relationship building
- Other duties as assigned

QUALIFICATIONS:
- Proven oncology Sales skills and results - knowledge of oncology disease states products
- Excellent written and oral communication skills and strong interpersonal, organizational, analytical and business skills
- Proven ability to create and innovate, build and expand business and work both independently as well as in teams
- Ability to quickly assimilate complex information
- Ability to succeed in a complex environment
- Ability to travel
- Knowledge of reimbursement
- Knowledge of territory and key accounts
- Candidate must live within the territory

To apply for this position, please CLICK HERE

Senior Development Engineer - Purification Process Development

Mon, 20 May 2013 01:55:38 EDT

Primary Duties:
The individual will be a key contributor within a group responsible for performing purification process development, including timely completion of small-scale experiments, scale-up, technology transfer and GMP support for programs that bring new biopharmaceutical products to pre-clinical, clinical and commercial manufacturing phases. The successful candidate will contribute to the design and execution of all related activities for the specific target molecule (these include therapeutic proteins and oligonucleotides) process development, troubleshooting, data analysis, authoring technical reports, and agency submissions. The experimental studies involve both lab scale and pilot plant runs, including, but not limited to toxicology, clinical and validation batches. The individual will effectively collaborate and communicate within the framework of cross-functional, multi-disciplinary process development teams. In addition this person will interact with other departments such as Manufacturing Sciences and Operations Support, manufacturing, plant engineering, validation and quality.

Responsibilities:
65% - Experimentation and manufacturing support related work including laboratory and pilot scale studies (chromatography and filtration unit operations) to support process development and optimization. Contributes to the evaluation of novel, generic platform technologies that can be applied across multiple programs. Participates during tech transfer of programs spanning all phases of biopharmaceutical lifecycle, including discussions of scale, equipment design and oversight of GMP, engineering and pre-clinical batches. Interacts with manufacturing operations staff, troubleshoots problems and supports their operations.
25% - Writing and reviewing data summaries as per established company guidelines and procedures. Authors technical reports, tech transfer packages and presentations. Contributes to regulatory submissions.
10% - Organizational support and cross-functional project team participation.

Education and Experience Requirements:
- PhD (0-3 years), MS (3+ years) or BS (5+ years) in Chemical/Biochemical Engineering or related discipline with relevant academic and/or industry experience.
- PhD engineering degree with chromatography expertise is the preferred qualification, including advanced understanding of relevant scientific theories, concepts, principles and small-scale experimental techniques.
- Product and purification process development experience in the biotechnology/pharmaceutical industry including scale-up, tech transfer and manufacturing support to large scale GMP operations is preferred.

Key Skills, Abilities, and Competencies:
- The candidate must be customer focused, results oriented, science driven and embrace Shire's values.
- Designs technical strategies to fulfill assignments under the general guidance of supervisor.
- Must have experience in Design of Experiment, statistical analysis and the ability to interpret data collected and derive appropriate conclusions.
- Authors high quality technical reports and presentations for management and peers.
- Contributes to publications in the field of expertise and to the preparation of CMC sections of regulatory filings.
- Familiarity with cell culture, fermentation and the analytical characterization of all types of proteins and nucleic acids (e.g. SDS PAGE, HPLC, ELISA) is desired. Working experience with process simulation is preferred.
- Experience with the purification of modified proteins and proteins expressed from differing sources is highly desirable.

Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives

Shire is an Equal Opportunity and Affirmative Action Employer

To apply for this position, please CLICK HERE

GMP Document Management System Administrator

Mon, 20 May 2013 01:51:27 EDT

Primary Role
This position will perform configuration activities, systems analysis and support the deployment and on-going administration of a 21CFR Part 11 compliant Electronic Document Management System (EDMS), QUMAS application. Responsibilities include understanding business processes, configuring the system to support the business process and on-going enhancements, and developing / maintaining system documentation.

Responsibilities
- 25% Ability to provide support to application changes by documenting the change, configuring the system, and testing the system changes in accordance with standard operating procedures.
- 25% Provide on-going systems administration services to ensure application availability in accordance with service level agreement (SLA). These services include but are not limited to the following: user account maintenance, application log file analyses, and application error troubleshooting/remediation (both server and desktop environments). .
- 20% Develop, test and implement Crystal Reports and Business Objects analytics to support on-going reporting needs.
- 20% Create and maintain system-related documentation including user requirements, design specifications, traceability matrixes, risk assessments and test scripts as required; as well as standard operating procedures, training plans and other user documentation.
- 10% Contribute to the definition of application deployment priorities to ensure application deployment activities reflect current business priorities
- Develop and sustain collaborative, professional relationships within Shire which reflect company values.
- Strong customer focus and ability to influence decision making is required.
- Participate in continuous improvement activities aimed at reducing cycle times, eliminating redundancies, and increasing throughput.
- Possess strong and effective verbal / written communications skills to effectively participate with cross-functional teams.
- Reading/writing in English is required.
- Develop and maintain a thorough understanding of business unit functions supported by the Information Technology group.

Education and Experience Requirements
- Minimal requirements include a Bachelor's degree in a scientific or business discipline and eight-ten years pharmaceutical or biopharmaceutical industry experience.
- Qualified candidates will have experience as systems analyst supporting an EDMS deployment.
- Qumas DocCompliance experience is a plus.

Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives

Shire is an Equal Opportunity and Affirmative Action Employer

To apply for this position, please CLICK HERE

Scientific Recruiter

Sat, 18 May 2013 05:01:24 EDT

The Broad Institute is a biomedical and genomic research center located in the biotech heart of Kendall Square in Cambridge, Massachusetts. Our Human Resource function consists of about twenty individuals who collaborate extensively with internal managers and support an organization of over 2,000 people.Whether you are a life sciences recruiter with a passion for science and a commitment to curing the world’s most intractable diseases, or an experienced scientific researcher with an interest in building teams and an understanding of the human side of organizations, we have an exciting opportunity for you!

We have an opportunity for a recruiter who is capable of influencing hiring managers by informing staffing decisions with an acute knowledge of the organization and a deep expertise of the research science labor market.You’ll create value by using your knowledge of the organization’s strategy, and how it impacts talent needs.
You’ll be able to prioritize requisitions based on your knowledge of the Broad’s overall strategy.You will build deep pipelines of talent based on their labor market expertise, particularly in the fields of chemistry, biology, computational biology, bioinformatics, translational medicine, proteomics, and pharmacology, to name just a few. Able to effectively engage, pursue, and convert candidates, both at the PhD and non-PhD levels.You’ll enhance staffing decisions using a persuasive communication style. Win the trust of hiring managers by establishing technical credibility and consistently demonstrating reliability and teamwork.

CHARACTERISTIC DUTIES
• Execute full life-cycle recruitment process, independently exercising professional expertise and judgment in planning targeted recruitment efforts, advising managers in job development and analysis and candidate screening, interviewing and selection.
• Works closely with hiring managers to understand the recruiting needs of all groups; anticipates hiring needs and proactively identifies recruiting solutions to meet those needs; develops long-term staffing strategies that drive long-term advantage.
• Develops effective sourcing strategies, sources candidates, conducts competency-based interview, checks references and executes the offer process. Sources and identifies candidates using all available tools, including but not limited to the following: applicant tracking and job board sourcing; initial contact, HR interview, technical interview, and administrative interview. Provides applicants with relevant organizational information.
• Screens and interviews potential candidates, makes informed recommendations on compensation, evaluating employment factors such as job experience, education and training, skills, knowledge and abilities, and other data pertinent to classification, selection and referral.
• Ensures the organization complies with laws, regulation and reporting as it relates to sourcing, recruiting and hiring with regard to AA/EEO policy. Plan and participate in industry job fairs. Contributes to the ongoing maintenance of internal career page.
• Conducts new hire orientation on a regular basis
• Assist with visa and work authorization procedures for selected candidates and current staff.
• Performs other related responsibilities as necessitated by the position or as assigned.
• B.A./B.S. degree and a minimum of 3 years of experience proactively recruiting qualified and diverse scientific candidates (i.e. Research Scientists, Research Techs, Postdocs, etc.).
• Expertise in tailoring effective recruiting and sourcing strategies to position needs, as well as advising managers in the selection and hiring of qualified and diverse applicants
• Demonstrated ability to develop and analyze job specifications, compose job descriptions and postings
• Demonstrated experience with creative sourcing techniques
• Demonstrated experience with applicant tracking systems and recruitment metrics
• Expertise in employment law, designing recruitment strategies, developing positions, including level and compensation analysis
• Proficiency in working with flexibility in establishing and meeting work plans while juggling multiple priorities in a fast-paced environment both independently and as a team member
• Proficiency in fostering positive interpersonal and "customer service" relationships
• Must be able to exercise sound judgment when problem solving and demonstrate a strong bias for action, sense of urgency, responsiveness, and customer focus

The Broad Institute will not offer visa sponsorship for this opportunity.

To apply for this position, please CLICK HERE

Senior GCP Quality Specialist

Sat, 18 May 2013 03:03:42 EDT

Senior GCP Quality Specialist (Vertex Pharmaceuticals Incorporated; Cambridge, Massachusetts):

Audit non-clinical and clinical activities related to industry standards and regulations for Good Clinical Practice (GCP). Assist with the proactive strategic alignment and refining of group or team goals for ongoing projects / activities to audit a wide range of GCP issues (e.g., investigator site management, in-trial, evaluation / qualification, data management, drug supply, training of QA staff, computer system validation, medical writing, and regulatory agency inspections). Travel required up to 30% of the time. Must have solid skills in oral / written communication.

Duties: maintain contemporary knowledge of current industry trends, standards and methodologies relating to GCP quality systems and management; communicate to manage expectations of clients and stakeholders; review and author SOPs and Work Instructions for GCP, with minimal supervision; represent the Quality Division on assigned project sub-teams regarding quality and compliance issues; implement and monitor quality activities to support the Company’s role in GCP; collaborate with internal departments on strategy and implementation of quality principles and regulatory requirements; and, work with all stakeholders and internal cross functional team members to foster GCP compliance.

REQUIREMENTS:
Minimum requirements are: B.Sc. (or equivalent degree) in Biotechnology, Pharmacology or relevant life science plus 5 years of experience, either in the position offered or in a relevant role as a clinical quality auditor. Alternatively, will consider qualified candidates with relevant M.Sc. in Biotechnology, Pharmacology, or relevant life science plus 3 years of relevant experience, either in the position offered or in a relevant role as a clinical quality auditor.

Must have: proven experience conducting clinical audits for drug discovery targets, including on-site investigations and the relating site surveillance; proven experience working with the relevant GCP regulations of the FDA and the ICH, including 21 CFR Part 11 (compliance with electronic reporting requirements) and Part 312 (Investigational New Drug Applications) and ICH Section E6; proven technical skills working with GCP protocols and the ability to provide effective guidance to the various stakeholders in a clinical drug environment (e.g., trial patients, FDA and ICH officials, scientific investigators, vendors, CROs, statisticians, and patients / consumers); must be willing to travel up to 30% of the time; and, proven skills in oral and written communication in a multidisciplinary team environment.

Send resume to: Lauren O’Hearn, Senior Human Resources Assistant, Vertex Pharmaceuticals Incorporated, 130 Waverly Street, Cambridge, Massachusetts 02139-4242.

No phone calls, please.

Reference: VX-201305. Vertex is an EOE/AAE.
HOW TO APPLY:
Please apply via Postal Mail
CONTACT ADDRESS1: 130 Waverly Street
Or
Email: lauren.ohearn@gmail.com

Research Associate, Biochemistry

Fri, 17 May 2013 04:58:21 EDT

Our client is seeking an experienced Research Associate to provide high quality technical support using plate-based biochemical assays, both kinetic and binding and enzyme kinetic data. In this position you will characterize basic biochemical and catalytic properties of recombinant enzymes and their interactions with small molecule inhibitors including mechanism of action. This position requires the ability to develop, optimize, validate, trouble shoot and execute biochemical assays as well as the ability to develop and execute cell-based assays utilizing a variety of technical approaches. This position requires a B.S. in Biochemistry or related discipline with a 4+ years of relevant industry experience. Solid quantitative skills and an understanding of biochemical assays and enzymology is required. Experience with automated liquid handling systems and standard cell biology techniques are a strong plus.

Research Associate, Process Development (Biologics)

Fri, 17 May 2013 04:42:40 EDT

We are seeking a dynamic talented RA to work in an exciting fast paced Process Development group. This position requires 1-3 years in a bioprocess development lab. Experience with bioreactor set-up, maintenance, and operations experience would be helpful. Understanding of Tangential Flow Filtration is required. Experience in protein purification including chromatography and filtration is required.

Reproductive Sciences Project Manager

Fri, 17 May 2013 04:05:00 EDT

The Jackson Laboratory, a world-renowned nonprofit organization focusing on mammalian genetics research, is looking for a dynamic Project Manager to work directly with our customers and our team. This role is at the intersection of science, business and superior customer experience.

The Reproductive Science Project Manager works with investigators to define the project scope, goals and deliverables.

The position is responsible for preparing quotations, overall project coordination, execution and completion. An in-depth understanding of genetics and mouse biology, a customer-centric focus, excellent communication skills, and proficiency with available project tracking and communication tools are essential to success in this position.

Education Qualifications / Experience Requirements:

Knowledge of reproductive sciences through bachelor’s degree in biological/life science (or equivalent years of relevant experience). Master’s degree an advantage.
Exceptional verbal and written communication skills required. Must be able to establish effective two-way communication with investigators and department heads regarding scientific needs and deadlines.
Demonstrated ability to provide exceptional customer service to understand the needs of investigators and provide workable solutions.
Superior organizational skills and attention to detail necessary to maintain project records and customer reporting.
Proven ability to work collaboratively with investigators and internal departments to achieve desired business results.
High level of proficiency with a variety of software tools including MS Office, laboratory information management databases (LIMs) and CRM solutions.

This position offers opportunities for advancement, and fulfilling interactions both with internal and external groups.

To be considered for this position, please submit a cover letter and resume as one document to requisition 3745 at www.jax.org/careers

Clinical Research Scientist

Fri, 17 May 2013 04:04:35 EDT

Clinical Research Scientist
Rresponsibilities include overall accountability for the clinical trial, execution of clinical trial objectives, the management of clinical trial timelines, authorship of clinical trial documents, budget management and overall trial oversight, in adherence with GCP-ICH guidelines, corporate SOPs & policies • Supports cluster head and cluster physician/clinical scientific lead in determining the overall clinical strategy and objectives of trials. • Within the Development organization, CRS supports process improvement and participates in working groups as applicable • Contributes to the project strategy and to the Clinical Development Plans • Primary responsibility ( together with Cluster Physician, Clinical Scientific Lead or Senior Clinical Research Scientist) for: o Preparing trial protocol, amendments and informed consent form, taking active part in study design internal discussion/meetings o Coordinating the preparation of other clinical trial documents including: CRF, diary cards, study manuals, IND updates, clinical summaries o Maintaining accurate and up-to-date information in project management systems and trial specific tracking systems (Clin Track) o Management of overall timelines for internal study document approval and trial allocation o Ensuring that appropriate documents are available to regional teams for timely submission to Ethics Committees and/or Regulatory Authorities according to local requirements • Supports cluster MD/Clinical scientific lead in preparation of investigators’ brochure • Contributes to preparation of Clinical Trial Reports/Clinical Study Reports • Contributes to clinical parts of regulatory dossiers and assists in the preparation of regulatory filings • Typically responsible for 1-4 trials of average design and protocol complexity (on lower end of capacity if responsible for trials of greater size and complexity, or across regions) Clinical Trial Execution and Trial Leadership • Maintains expertise in GCP and clinical trial methodology • Can fill the role of cCTL(central clinical trial leader) for clinical trials including clinical project management • As cCTL, leads the clinical trial team, retains overall accountability for the clinical trial including compliance, quality, budget tracking and timelines throughout the trial • As cCTL, coordinates all central activities for the clinical trial (e.g. serology, data management, clinical supplies, data listing review, rCTMs, regulatory issues, interaction with CTGE if same CRO is used globally etc.) • Together with Regional Team and the rCTM(s), supports organization (especially in case of global meetings), attends, makes presentations and provides GCP/ICH/FDA regs/SOP training at investigator meetings as appropriate and assures continuity and alignment with the trial objectives and overall clinical program throughout the trial • Interact with other cCTLs, CRS and regional CTMs to share best practices, lessons learned and implementation of improvements • Actively participates and contributes to cluster meetings Potential Additional Responsibilities • Maintains expertise in Cluster’s projects and in the medical and scientific issues of vaccines development, • Responsible for budget coordination for all trials within cluster and overview of trial budgets • Interacts with representatives, ethics committees and opinion leaders and participates in meetings as appropriate • Helps with presentations at internal and external meetings, authorship contribution to publications • Coordination of DMC activities

Minimum requirements • Bachelor degree required (or comparable), preferably in a science or health related discipline • Post graduate degree in a life science field desirable • Excellent knowledge of written and spoken English • At least 5, preferably 7+ years hands-on experience in clinical research comparable to Novartis Vaccines experience and scope (i.e. responsible for trial document preparation, site management, study and team coordination) • At least 2 years of experience in regional clinical trial leadership desirable • Project Management skills and general understanding of project management tools (e.g. MS Project) • Previous experience in the field of vaccinology desirable • In depth knowledge of GCPs and ICH Guidelines • Solid understanding of clinical trial design, trial execution and operations • Understand business implication of clinical trial design and execution • Excellent communication and presentation skills (both written and verbal), attention to detail, good organizational skills and proactive approach to problem solving • Demonstrated solid experience working on teams with a broad range of cultures including team leadership is desirable

Digital Marketing Assistant - Part-Time

Fri, 17 May 2013 03:54:00 EDT

This position supports the Digital Marketing team to both update existing content, as well as develop new web-based content, associated with NEB’s product portfolio and our promotions via a multitude of digital marketing tactics.

Primary Responsibilities:

Content development and management for neb.com, as well as our international website and that of the Singapore Subsidiary.
The development of new content associated with new product launches and targeted promotional campaigns.
Support for NEB’s social media program, including strategy review and development, as well as communication across its many channels (FB, Twitter, LinkedIn, Google+, etc...).
Keyword research selection and optimization for online campaigns.
Product, campaign and branded PPC and SEM support, including working with the different third party vendors that support NEB.
Branded and non-branded organic SEO optimization, both with and independent of NEB’s third party support vendors.
The placement and support of rich media on NEB’s websites, including animation and video (tagging, international distribution, YouTube analytics and reporting, etc.).
Support for NEB’s email marketing program, including creation and execution of email blasts, coordination with content writers and graphic designers, analytics, reporting and salesforce.com lead synchronization.

Required Qualifications:

3 years experience in digital marketing and website creation/ development.
Knowledge of digital marketing tactics including website development and basic html.
Experience using Google Analytics.
Experience using Content Management Systems.
Experience in social media management, as well as platforms such as Twitter, Facebook, LinkedIn, etc…
Experience using SEO and SEM.
Strong project management skills and the ability to multi-task, prioritizing and managing multiple projects, simultaneously.
Meticulous attention to detail and an eye for consistency.
Ability to work independently and problem solve.
Ability to work in a team setting as an integral member of the Digital Marketing Department, and with Marketing Communications, Product Marketing Managers and occasionally Product Managers or other scientific staff.

Preferred Qualifications:

B.A. in marketing or communications preferred
Strong interpersonal, verbal and written communication skills.

New England Biolabs, Inc. is an equal opportunity/affirmative action employer

Candidates may apply online at www.neb.com