Director, Medical Affairs - Remote

Those who join Emergent Bio Solutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

JOB SUMMARY The Medical Director provides medical and scientific input into core strategic and operational medical affairs activities such as medical strategy, HCP engagement, support of company sponsored trials, scientific congress support, evidence generation, educational initiatives, and scientific communications. These will include both US and ex-US Medical Affairs initiatives. The Medical Director works closely with commercial and clinical teams to provide critical medical strategic input into evolving core medical strategy.

Specific duties include strategy as a subject matter expert, leading Promotion Review Committee for medical, coordinating Medical Information needs with our communications team and engaging with external experts as part of medical affairs strategy for publications/IITs/CME. This role will provide scientific matter expertise for internal needs within the therapeutic area or brand.

ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Serve as the subject matter expert to support therapeutic area priorities and growth strategies

Leads Global medical affairs activities by developing the therapeutic area strategy and provides medical leadership to the Global Medical Affairs Team.

Lead as the primary Medical Reviewer and Subject Matter Expert (SME) for Promotional Review Committee (PRC) and Medical Review Committee (MRC)
Provides medical review of Promotional and Medical Affairs materials to ensure statements are scientifically accurate, truthful and non-misleading, and that promotional claims are adequately supported, including the appropriateness of references cited

Lead cross-functional teams (including Marketing, Regulatory Affairs, and Legal) to ensure collaborative outcomes on work streams aligned to scientific strategy

Lead content development in collaboration with the Medical Communications team for Medical Information and training related documents; with ability to submit documents into Veeva Vault as needed

Create, review, and maintain Medical Affairs scientific materials, scientific slide decks, and internal training/directive documents

Lead collaboration with Medical Communications to support Med Inquiries and engage in appropriate scientific exchange  Collaborate with Medical Affairs team members and external vendors/consultants to facilitate the development of content for specific identified goals aligned to strategy

Collaborate with Global Safety & Epidemiology, to provide support for data generation and any potential external communication tools (pubs, presentations)
Provide training to internal business partners as needed on disease state or product

Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities. The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS Advanced scientific or clinical/medical degree required (MD, DO, PharmD, PhD, MPharm or equivalent)
Experience in leading cross functional teams within a complex matrix environment

Understanding of US and Ex US business needs to develop comprehensive support plans5+ years of working experience within the pharmaceutical industry and 2+ years of professional experience in Medical Affairs is required

Lead promotional/medical review
-experience required

Prior experience in digital review systems is required;
Veeva Vault and/or Veeva Med Comms is preferred

Prior experience in training/teaching

An established track record of facilitating effective…