Associate Manager - Medical Affairs

Job Description
Reporting to the Sr. Director of Viral Hepatitis, Global Medical Affairs, this role is a key position within the Global Liver Inflammation, Virology and Established Products (LIVE) Team. This role is within the LIFE (Liver, Inflammation, Fibrosis and Established Products) Medical Affairs organization. This is a global role that involves the development and execution of global strategies for products in the LIVE franchise. The individual must be a self-starter and able to lead the development of global strategic activities as well as develop and execute them on a tactical level. As part of the global liver diseases medical affairs group, there will also be an opportunity to work across viral hepatitis, with the possibility of other LIVE therapeutic areas, should business needs arise. The key functions of this role will be to collaborate with internal and external stakeholders including the Foster City Medical Affairs team, Scientific Publications, Medical Affairs Research, Marketing, Global Commercial Product Strategy, Value and Market Access, Clinical Research, Public Affairs, Government Affairs, Contracts/Finance, Pharmacology, Virology and Legal on both the global and regional levels.
Specific Job Requirements

Demonstrate deep subject matter expertise with regard to LIVE products as well as Client s pipeline and competitive products.

Prepare presentation materials for internal and external meetings, including Advisory Boards.

Serve as an information resource and trainer to Client s colleagues, including the Medical Scientists, including medical educational activities, grants and investigator-sponsored/collaborative studies

Support data generation activities through:

o Critical review of global ISRs, Ph 3b and P study proposals

o Manage HBV Phase IV portfolio as a Global Project Manager, including liaising with key cross-functional partners such as clinical operations and local affiliate

o Review abstracts and/or manuscripts that result from the phase IV program

o Support the management and documentation of phase IV study status

Serve as Medical Affairs therapeutic area expert on Global Publications and Scientific Message Platform committees and other support for Scientific Communications

Provide medical and scientific coverage and support at key scientific meetings

Support project leads in the execution and tracking of their projects (eg. Global Medical Affairs Plan of Action, publications, reviews of medical and commercial assets, etc.)

Oversee medical and scientific review of promotional materials for GRC and MRC

Support tracking of purchase orders, budget tracking and invoicing for the viral hepatitis franchise

Other activities, as assigned, to support LIVE Medical Affairs
Essential Skills:

Excellent written, verbal and interpersonal, relationship-building and negotiating communication skills

Excellent organizational skills to support project planning across multiple activities, anticipate and prioritize workload

Excellent teamwork skills. Organized; attention to detail and able to meet timelines in a fast-paced environment

Excellent analytical and problem solving skills, demonstrated ability to identify and understand complex issues and problems and identify and query key findings from study data and publications

Experience in public health or Internal Medicine (general or subspecialty) is highly desirable, in addition to clinical patient care.

Experience in developing effective abstracts, manuscripts, posters and slides and presenting at scientific meetings

Must be fully cognizant and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; thorough knowledge of FDA regulations, ICH guidelines and Google Cloud Platforms governing the conduct of clinical trials

Must be able to work with autonomy and independence

Ability to work around international time zones and ability to travel to and participate in domestic and international conferences which will include occasional weekend travel is required

Ability to work in a global environment which will require participation in meetings outside of standard work hours and on the weekends to accommodate time zone differences
Knowledge, Experience & Skills

Bachelor s degree a minimum, but M.D., D.O., PhD (biological or pharmaceutical sciences), or PharmD preferred. Prior experience in hepatology, infectious diseases, virology or clinical virology a plus.

Preferred experience in Medical Affairs and/or Clinical Research including Phase IIIb and IV studies; clinical trials management, medical monitoring and scientific expertise