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About the Role
This role is for a medical writer and leader at the Senior Director level, providing specialist content strategy and development expertise for regulatory guidance and industry standards. You will lead at the therapeutic area or portfolio level, overseeing strategic planning and drafting of complex submissions and other clinical, regulatory, or business content. You will collaborate with cross-functional teams to deliver documents on time and drive document strategy.
Responsibilities
- Leads and manages a team of direct reports and may manage external contractors and/or other people leaders.
- Hires, develops, and retains diverse top talent in the team.
- Ensures the team and the assigned work comply with established practices, policies, and processes and any regulatory or other requirements.
- Leads at the TA or portfolio level, overseeing strategic planning and drafting of the most complex submissions across TAs.
- Leads cross-functional teams to organize information and identify key messaging and supporting data to achieve submission objectives.
- Oversees, guides, and directs all deliverables and activities performed by the assigned team.
- Communicates changes to regulatory requirements and assists with the development of relevant cross-functional training programs, alongside process improvement initiatives on document standards, processes, and template development.
- Leads other special projects and represents the CSD function in other cross-functional initiatives.
- Acts as the subject matter expert, providing specialist medical writing expertise for clinical/regulatory documents for business-critical and high impact projects.
Requirements
- BA/BS or advanced degree in life sciences or related field with significant experience leading or co-leading large-scale, highly complex cross-functional work, projects, and teams in life sciences, including leading short- and long-range strategic planning, governance, and oversight.
Skills
- Content strategy
- Content development
- Medical writing
- Regulatory submissions
- Clinical research
- Clinical operations
- Clinical pharmacology
- Patient safety
- Clinical data science
- Strategic planning
- Team leadership
Experience Level
- Senior Director
Education Level
- BA/BS or advanced degree in life sciences or related field
About the Company
- Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need including virology, oncology, and inflammation.
- Gilead Regulatory Affairs is a committed and proud team of highly skilled professionals dedicated to helping deliver therapies in the most efficient and effective way to patients with unmet medical need around the world.
- The Content Strategy & Development (CSD) department is part of Innovation, Content, & Execution (ICX) within Regulatory Affairs, and advances the strategy and creation of high-quality documents to support efficient and successful regulatory submissions.
- We are an inclusive and diverse community, supported by strong leaders who are committed to providing individual development and growth opportunities while achieving our mission.
- Our collaborative and supportive structure help support work-life balance.
Equal Opportunity
- It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company.
- Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws).
- Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.