Associate Director, Regulatory Affairs - OPDP
Summary: The Associate Director of Regulatory Affairs, Advertising and Promotions is responsible for providing strategic and operational leadership in the area of advertising and promotion. The Associate Director will serve as AMAG's regulatory liaison to the FDA Division of Drug Marketing, Advertising and Communications (OPDP) for all company products. The candidate should possess proven ability to impact and influence cross-functional teams and work effectively with senior management; as well as excellent written and verbal communication skills. The successful candidate will have expert knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of advertising and promotion. This person will establish SOPs for review, approval and submission of advertising and promotional materials to the FDA, and will serve as primary contact with FDA OPDP. A proven track record of successful interaction with OPDP is required
Essential Duties and Job Functions include but are not limited to the following:
In this position, the candidate will be responsible for regulatory strategy and operational leadership in the area of product labeling and commercial communication for AMAG products and development programs. Working in a team environment, the Associate Director will be responsible for development of product labeling, including package inserts and core labels. This position is responsible for establishing processes and procedures to ensure that marketing and other commercial communication are in compliance with applicable laws, regulations and guidelines. Working closely with Marketing, Medical Affairs, Legal, and Strategic Communication, the Associate Director will be involved in the development of advertising and commercial communication materials that support corporate goals and comply with applicable FDA regulations and other regulatory authorities worldwide.The Associate Director will also monitor the external environment to advise AMAG on evolving regulatory requirements related to advertising, labeling and promotion.
The incumbent is responsible for performing regulatory review of advertising and promotional materials and provides expertise with respect to the requirements for promotional materials as set forth by OPDP. Develops and maintains a positive working relationship with regulatory colleagues in-house and business partners; advises project teams on regulatory best practices regarding planning and execution of marketing strategies; and also assures that cross-functional advertising and promotion review teams are operating according to approved company compliance processes.
- In depth working knowledge of regulations and their implementation and specific experience in the area of advertising and promotion and the support of multiple commercial products are required.
- The applicant must have demonstrated leadership skills and ability to interact and influence Teams and senior management.
- Excellent written and verbal communication abilities are essential.
- Expert knowledge of the pharmaceutical business and proficiency at representing/interpreting the strategic business objectives of the company is critical.
- Experience working directly with OPDP is critical.
- A proven track record of successful interaction with OPDP is preferred.
- The candidate should possess proven ability to impact and influence cross-functional teams and work effectively with senior management; as well as excellent written and verbal communication skills.
- The successful candidate will have expert knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of advertising and promotion.
- Direct advertising and promotional material review experience.
- Able to communicate effectively and maintain effective working relationships. Must be able to effectively influence peers and others within the organization.
- Proven ability to prioritize and multi-task with minimal supervision based on interactions with project team members.
- Excellent written and verbal communication skills (native and non-native English speakers) with the ability to meet regulatory requirements and standards while maintaining effective relationships.
- Strong organizational skills and high level of attention to detail, with the ability to coordinate multiple large and diverse projects simultaneously.
- Editorial skills and ability; experience developing and managing technical processes and procedures
- Project management skills and experience: ability to present recommendations, sequence work, identify cross-functional needs, drive to completion, provide reports and evaluate results
- Excellent presentation skills including ability to tailor information and delivery to audience; manage pace, timing and audience engagement; field and respond to questions; adjust approach and content to last minute changes; present in various formats (slides, video, speaking) and delivery methods (teleconference, video conference, webcast, panel, platform, office demonstration)
The functions will include the responsibility for the creation and maintenance of the Company Core Datasheets (CCDS), US Package Inserts (USPI), participate in the Centralized Procedure or Mutual Recognition Procedure EU Summaries of Product Characteristics, EU Summaries of Product Characteristics and Patient Labeling, as well as, review of package labels for US and EU submissions. The following are the major responsibilities:
- This individual will review, help develop, and approve advertising, promotional materials, sales training and other materials involving communications about marketed products.
- This person will also submit advertising and promotion material to regulatory agencies as appropriate.
- He or she will ensure that agency feedback on any promotional activities is shared with appropriate individuals and the information is retained in a manner to enhance institutional use of that information.
- This person will review, help develop, and approve presentations and materials to be used by medical liaisons and other scientific staff, as well as review for publications, abstracts, and the use of these materials.
- The candidate will have the responsible for the training of regulatory, commercial, clinical and medical staff, as required
- This individual will also assist with the development and delivery of compliant training programs with respect to the regulations and guidance impacting advertising and promotion and the development of company procedures.
- The incumbent must have the ability to develop an understanding of the data available for the commercial products and assess promotion, publication, and medical information document content referencing such data.
- Ability to prepare final proposed target product profile that is in line with clinical development plan and the regulatory strategic plan for review by Labeling Working Groups and Labeling Review Committees and represents the labeling position prior to submission to regulatory authorities.
- Drive Labeling Strategy development and backup strategies for label negotiation. Resolve issues that arise during labeling negotiation and cannot be resolved using the backup strategies.
- Resolving labeling issues that arise during post-approval and providing input on timelines for label dissemination and implementation timelines as necessary.
A BS/BA, MS, JD or PhD degree in a relevant discipline and 8 years previous industry experience; with about 5 years in RA advertisement and promotional activities.
Scientific knowledge in chemistry, general biological/physical science and ability to apply that knowledge to regulatory issues and product development with technical complexity.
Please apply via our website: www.amagpharma.com