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Associate Manager

4 months ago

Foster City, United States Intelliswift Software Full time

Job Title: Manager, Global Medical Affairs (Hepatitis B)

Location: Foster City, CA

Duration: 6 Plus Months + will extended


Job Requirements:

• Demonstrate deep subject matter expertise with regard to LIFE 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

• Support data generation activities through:

o Critical review of global ISRs, Ph 3b and Ph4 study proposals

o Manage HBV Phase IV portfolio including liaising with key cross-functional partners such as clinical operations and local affiliates

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

• Other activities, as assigned, to support LIFE 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 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


Education & Experience:

• 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