Global Medical Affairs Specialist
ABOUT THE POSITION:
This positon will support Global Medical Affairs (GMA) focus areas, including medical/regulatory/legal review of medical materials (MeRL), medical education grants, and global medical information. The Global Medical Affairs Specialist consistently applies a clear understanding of Medical Affairs current best practices and regulatory requirements to ensure process and system compliance. This position reports to the Director of Global Medical Affairs Operations.
Key functions of the Global Medical Affairs Specialist are: 1) To serve as GMA's MeRL Coordinator; 2) To serve as GMA's Medical Education Grants Coordinator; 3) To provide extensive support to Global Medical Information, from both a scientific and an operational perspective. The employee must have a creative, practical and flexible approach to problem solving and project management, and must understand departmental operational needs and develop a deep familiarity with the scientific data.
ESSENTIAL DUTIES AND KEY DELIVERABLES:
- Assist with key Global Medical Information responsibilities, both scientific and operational:
- Provide subject matter expertise (SME) and accuracy checks for medical materials review; support creation and review of both standard and custom responses
- Respond to unsolicited inquiries and handle escalated responses
- Appropriately represent the company at medical/scientific congresses and respond to inquiries from health care professionals with accurate and balanced information
- Manage external medical communication agencies to develop timelines and manage the process for successful execution of assigned projects
- Work with regional Medical Affairs colleagues on a global basis to ensure consistency and efficiency of medical information responses worldwide
- Support training of call center staff in all global regions through both live assistance and creation of user manuals and other training materials
- SOP and process development and revision, system (IRMS) configuration and administration, system content management, validation and testing activities
- Coordinate the MeRL Committee's activities, including materials routing for approval, quality control, interfacing with agencies and other key stakeholders, leading committee meetings, developing agendas, revising and maintaining SOPs and facilitating rollout of and compliance with process changes
- Provide agency oversight and project management as needed for individual scientific projects
- Coordinate the Medical Education Grants Committee's activities, including routing grants for approval, communicating with applicants, providing summaries and recommendations for grant support, leading committee meetings, developing agendas, revising and maintaining SOPs and facilitating rollout of and compliance with process changes
- Provide metrics on all activities as needed for GMA reports to senior management and other key stakeholders
- Other research or work activities as needed in order to support these functions.
Core compentencies, education, and experience.
- Strong preference for advanced degree; e.g. PhD, PharmD, etc.
- 1 to 3 years of pharmaceutical/biotechnology industry experience preferred
- Knowledge, understanding and adherence to global regulatory guidelines (e.g. FDA, PDMA, JPMA, PhRMA, etc.)
- Exemplary interpersonal communication skills, both oral and written, and strong presentation skills
- Advanced problem-solving, project management and process improvement skills
- Strong analytical, conceptual, administrative, and computer skills
- Demonstrated ability to comprehend complex scientific data and concepts, and to communicate effectively to a variety of audiences
- Proven ability to interact with employees at all organizational levels in a culturally diverse work environment; previous experience working in a global matrixed organization strongly preferred
- Ability to work locally based in the Emeryville office; availability to travel domestically and internationally up to 20% of the time
Why Kelly **** ?
With Kelly, you'll have access to some of the world's highest-regarded scientific organizations-providing you with opportunities to work on today's most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you'll be proud to help advance. We work with 95 of the Fortune 100 companies, and found opportunities for more than 9,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career-connect with us today.
AboutKelly Services ****
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook at https://www.facebook.com/kellyservices , LinkedIn at http://www.linkedin.com/company/kellyservices and Twitter at https://twitter.com/kellyservices .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm