Associate Manager - Medical Affairs*
Associate Manager - Medical Affairs*
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Salary Not Disclosed
1 Vacancy
Job Description
Job Duration: 6 months
Job Location: Foster City California
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.
Demonstrate deep subject matter expertise with regard to LIVE products as well as pipeline and competitive products.
Prepare presentation materials for internal and external meetings including Advisory Boards.
Serve as an information resource and trainer to colleagues including the Medical Scientists including medical educational activities grants and investigator-sponsored/collaborative studies
o Critical review of global ISRs Ph 3b and Ph4 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
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
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 GCPs 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
Bachelors 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
Employment Type
Remote
Company Industry
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
