Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.
Medical Affairs . Bothell, Washington
Description Summary: The Director, Global Medical Information serves as a global medical information strategic leader to deliver functional excellence relative to global medical information deliverables and overall business strategy in collaboration with internal colleagues and business partners. The Director is responsible for leading a team that communicates global scientific and medical information to health care professionals, patients, and consumers. This Director is accountable for ensuring that the department responds to unsolicited requests for information in an accurate, consistent, compliant, and timely manner. Additional responsibilities include identifying and developing solutions to improve efficiencies and to reduce risk across the department. The Director will lead efforts to ensure audit readiness, develop and maintain functional policies and procedures, quality assurance, measure operational effectiveness, and support global expansion of Medical Information. The Director manages the Medical Information staff, fosters teamwork, motivates team members towards the achievement of objectives, develops and mentors individuals, advocates for departmental needs, and works collaboratively with business partners across the company.
Leads and manages Medical Information staff; develops, coaches, and supports the professional growth of individual staff members
Creates and/or updates policies, standard operating procedures, and training guides to optimize work flow and ensure high quality provision of Medical Information consistent with regulatory guidance. Ensures compliance with all applicable corporate and HQ policies
Leads process improvement initiatives and development strategies to optimize medical information policies and procedures towards global alignment
Drives optimization of resources and utilizes outsourcing options when appropriate
Partners with Pharmacovigilance and Quality Departments to ensure AEs and PCs are captured and triaged in a timely and compliant manner
Collaborates with Global Medical Affairs team members to develop a strategy, prioritization and project plan for the development, maintenance and review, approval for global medical response documents; partners with affiliates to assist in development of local Medical Information strategies based on regional requirements
Responsible for Medical Information resourcing for program promotional review, commercial training initiatives, medical congress support, compendia working group, dossier review, and contributes to other business initiatives throughout lifecycle of assigned product(s)
Works collaboratively with functional area leads in Medical Affairs and other internal stakeholders to ensure the department is successfully supporting Medical Affairs strategies
Works collaboratively with alliance partners, and represents Medical Information in alliance partnership meetings
Provides verbal and written clinical and technical responses from the health care community, patients and internal customers as it relates to Seattle Genetics products
Provides sound medical judgment to quickly identify and be able to address medical issues and concerns as a result of medical inquiries received
Contributes to departmental/organizational efforts to support new product launch preparation and activities, including supporting global expansion
Other initiatives or duties as relevant to function or designated by Supervisor
5-7 years of pharmaceutical industry-based experience required with at least 3 years in Medical Information or Medical Communications
Superior leadership skills and prior management experience required
Knowledgeable of applicable regulations regarding dissemination of medical information, drug promotion, and adverse event/product complaint reporting
Highly motivated to function proactively, operate with a sense of urgency, and bring tasks to completion
Demonstrated ability to work cross-functionally
Excellent leadership, interpersonal, and verbal and written communication skills
An advanced healthcare degree is required (PharmD, MD, PhD)
As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.