Manager- Preclinical Documentation
* Coordinate, manage, plan, and track all aspects of Nonclinical (NCD) global regulatory documentation projects from development stage through post-marketing with Regulatory Affairs/Operations (GRA/O).
Coordinate, manage, plan, and track all aspects of NCD global regulatory documentation projects from development stage through post-marketing with Global Regulatory Affairs/Operations.
* Work with NCD and GRA project/program teams/subteams to prepare submission content plans that define content, assign project responsibilities, and determine the project timeline and senior management review and approval.
* Collaborate effectively with GRA/O staff and contributing functional areas to assure adequate prioritization, scheduling, preparation, and dispatch of regulatory submissions including proactive communication of requirements and issues to be considered by the Submission Team (Regulatory) and contribute to achieving realistic timelines.* Communicates and coordinates cross-functionally to gain endorsement of timelines and assignment of responsibilities.
* Manage and track project timelines to ensure regulatory documentation meets the defined timelines and content requirements and that milestone dates are met by contributors and reviewers.
30%: Create and maintain accurate NCD regulatory project/program trackers for distribution; manage day-to-day operational process for NCD regulatory submissions.
* Utilize regulatory knowledge to create detailed project plans, timelines, and identify key components, interdependencies and resource requirements for submissions components.
* Track evolving group performance metrics and gaps monthly and quarterly, and create status and database reports as needed.
10%:Liaise with NCD, Regulatory Affairs/Operations and other cross-functional groups within and outside R&D to monitor submission processes and work with GRA/O to continually refine. Coordinate staff training and ensure NCD compliance with Shire Regulatory Standard Operating Procedures and Working Procedures.
* Represent Nonclinical Development in Global Regulatory Affairs project/product meetings.
* Align with global Regulatory group processes; work directly with NCD and GRA/Ops teams to continually assess opportunities for improvements in best practices and overall operational excellence.
* Lead or participate on NCD-related regulatory project teams/subteams and special projects. Work closely with CROs, external vendors, business partners, and other Shire departments such as legal, clinical, business development, as required.
Education and Experience Requirements:
* Bachelors or Masters degree or higher in a relevant technical or scientific field is required.
* At least 3 years experience compiling nonclinical documentation or regulatory submissions; preferably within the pharmaceutical/biotech industry is required.
* Experience in a regulated environment (eg, CRO or global regulatory agency) with sound knowledge of relevant global regulatory agency regulations/ expectations and industry standards/best practices pertaining to regulatory operations and submissions is required.
* Fluency in written and spoken English is required.
Key Skills, Abilities, and Competencies:
* Understanding of the drug development process (both large & small molecule) and a solid understanding of regulatory requirements for the format, content, and quality of nonclinical documentation.
* Highly effective organizational and planning skills.
* Excellent interpersonal, oral, and written communication skills.
* Ability to effectively engage with a wide variety of internal/external technical and business experts.
* Ability to work in a high-visibility, fast-paced environment while handling multiple priorities. Must be flexible, detail-oriented, and possess good analytical and problem-solving skills.
* Ability to be a leader or member of project/program submission teams/subteams and manage overall regulatory group processes effectively.
* Highly experienced with MS Word, MS Excel, MS PowerPoint, Adobe Acrobat, and other electronic publishing software/tools.
* Experience with electronic document management systems (eg, Documentum) and standards is highly preferred.
* Keen attention to detail in composing, reviewing, and editing technical and nonclinical documentation.* Must be customer orientated with a good awareness of customer expectations.
Other Job Requirements: Domestic and international travel may be required.
Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives
As an Equal Opportunity and Affirmative Action Employer, Shire is committed to a diverse workforce. US Applicants who require accommodation in the job application process may contact 484-595-8400.Please apply at: Application URL: http://www.aplitrak.com/?adid=YWxlYXRvbi45ODU0OC4zMTY3QHNoaXJlLmFwbGl0cmFrLmNvbQ