Senior Manager - Medical Reviews

Job Title: Senior Manager - Medical Reviews

Location: Cambridge, MA

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

The Senior Manager, Medical Review is a Cambridge-based member of the US Medical team in the Rare Blood Disorders franchise covering portfolio.  The mission of this team is to support the company by functioning as the internal expert in rare blood disorders and therapies and helping Health Care Professionals and Payers optimize patient care and treatment outcomes through evidence-based decisions.  We feel this is best accomplished through the generation, interpretation and communication of accurate clinical and scientific information.  The Senior Manager plays a key role in this mission by providing strategic input into the rare blood portfolio and reports to the Director of Medical Operations.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

The Senior Manager of Medical Reviews will:

• Ensure timely Medical Material and Promotional Material reviews via the Medical Material Review Committee (MMRC) and Promotional Review Board (PRB).

• Ensure full compliance with all corporate and industry policies and legal and regulatory requirements, for all medical affairs activities

• Ensure promotional/non-promotional review for assigned products in the RBD BU, which include major assets, sound medical advice that minimizes the risk of regulatory and legal action, competitively positions assigned products and is consistent with applicable FDA regulations and company policies for advertising and promotion of prescription drug products and biologics

• Provision of competitively positioned promotional materials that comply with applicable FDA and corporate regulations, policies and guidance

•  Analyze whether clinical and non-clinical promotional claims are supported

•  Provide insight, judgment and sound decisions on promotional programs and tactics for assigned products.

•  Maintain a deep and current awareness of evolving FDA regulations and interpretations, FDA advisory comments, enforcement letters and policy issues affecting the pharmaceutical/biologics industry and communicate relevant information appropriately to stakeholders.

• Advise on the development of US labeling to ensure support for anticipated promotional messages and claims.

•  Develop/maintain an in-depth understanding of labeling for assigned company and competitor products and the subsequent translation of that knowledge into the development of promotional materials.

• Ensure application of key learnings across assigned brands, ensuring alignment of development and commercial objectives

• With limited supervision, recommend appropriate actions for proposed advertising and promotion sometimes with little or no precedent

•  Develop/maintain an in-depth understanding of labeling for assigned company and competitor products and the subsequent translation of that knowledge into the development of promotional materials.

About You

Qualifications:

• Advanced degree (PhD, PharmD, MD) required

• Previous experience in medical review or ad-promo either in industry or agency highly preferred

• Demonstrated detailed orientated and strong attention to data accuracy and consistency

• Be hands-on and accountable

• Possess outstanding communication and influencing skills, able to work in a multi-cultural environment, and represent the company with utmost professionalism in a wide array of forums

• Be a critical thinker, able to share fact-based opinions

• Able to make complex science understandable for a non-scientific audience

• Results-oriented, can embrace a fast-paced “can do” culture undefined

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless