Senior Manager, Medical Writing - Oncology
October 9
Description
• Medical Writing acts as a strategic partner across drug discovery, development, and commercial teams. • Participate in cross-functional drug discovery, development and commercial product lifecycle management. • Collaborate cross-functionally to advance Gilead's product strategies and ensure successful licensure and maintenance of licensure of Gilead's medicinal products. • Author a wide range of regulatory documents independently, including documents of high complexity • Lead review and planning processes for multiple products or projects. • Represent Medical Writing on relevant product, project, and/or regulatory submissions teams.
Requirements
• PharmD/PhD with 4+ years’ relevant experience • MA/MS/MPH/MBA 6+ years’ relevant experience • BA/BS with 8+ years’ relevant experience • Significant medical writing, regulatory, quality, clinical R&D, or related experience supporting medicinal products • Significant experience in the biopharma industry is strongly preferred • Experience authoring a broad range of regulatory, scientific, and/or medical documentation across multiple stages of drug development • Experience working with one or more Gilead TAs and varying stages of drug development is strongly preferred • BA/BS or advanced degree in life sciences or related field with significant medical writing experience in the biopharma industry • Demonstrated ability to be a fast learner • Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed • Recognized as a SME in a broad range of regulatory documentation and a resource for specialist advice and guidance • In-depth knowledge of relevant health authorities, including system, processes and requirements • In-depth knowledge of regulatory document requirements and guidelines relevant to assigned products, projects, and markets, as evidenced by effectiveness and successes authoring a broad range of regulatory documentation • Able to advise cross-functional partners on standard/routine regulatory documentation and processes to meet business goals and objectives • Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, project management skills and proficiencies with Microsoft Office suite, as evidenced through accomplishments in past roles • Ability to lead and influence programs, projects and/or initiatives • Strong interpersonal skills and understanding of team dynamics • Proven ability to work successfully in a team-oriented, highly matrixed environment • Capability to attend evening meetings as needed to support ROW submissions • Significant oncology therapeutic area experience is strongly preferred • When needed, ability to travel
Benefits
• Company-sponsored medical, dental, vision, and life insurance plans* • Discretionary annual bonus • Discretionary stock-based long-term incentives (eligibility may vary based on role) • Paid time off • For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
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