Senior Director, Regulatory Documentation and Submissions
Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need including oncology, virology, inflammation. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world.
Document Development and Disclosure, part of Regulatory Affairs, is a global and diverse team of highly skilled professionals. We work collaboratively to advance strategy and create high-quality documents for successful regulatory submissions, by bringing our passion for science, discovery, and innovative strategic thinking into our daily work. We are dedicated to attracting new talent with diverse backgrounds and experiences. We are committed to providing individual development and growth opportunities while promoting a healthy work-life balance.
We have an exciting and unique opportunity for a Senior Director to join our dynamic team. You will oversee Medical Writing department personnel and deliverables for all Gilead oncology programs.
You will work collaboratively within cross-functional teams (eg, Regulatory Affairs, Clinical Development, Clinical Operations, Clinical Pharmacology, Global Patient Safety, and Clinical Data Science) to lead large clinical programs and drive document strategy for Medical Writing.
This position is open to US office locations, or remote based candidates.
- Acts as an advisor to development functional groups on the content and optimal presentation of clinical/regulatory documents in accordance with regulatory document requirements/guidance.
- For complex regulatory submissions, oversees strategic planning and manages cross-functional authoring teams to identify key document messages and substantiate data for delivery of target labels and to minimize regulatory questions.
- Oversees and manages/supervises medical writers and contractors to ensure the highest quality of medical writing and adherence to Gilead document standards.
- Represents Medical Writing on cross-functional initiatives/teams backing key company goals.
- Leads cross-functional process improvement initiatives on clinical document standards, template development, and document processes.
- Assists with budgetary and resource projections for oncology programs and the department.
- Author clinical/regulatory documents and perform other medical writing activities, working autonomously without direction, while ensuring effective teamwork with key contributors.
You Will Need:
- Extensive clinical research and development, regulatory affairs, or related industry or academic experience in a medical writing environment, managing staff and directing and preparing documents for regulatory submissions.
- The ability to understand the needs of cross-functional teams and to lead strategy for resourcing and content of any medical writing deliverable.
- The ability to balance integrity and efficiency when managing document and submission strategy.
- Extensive knowledge of global regulatory affairs and particularly the requirements and mechanisms for regulatory approval in the United States and Europe.
- Excellent medical writing, verbal communication, and project management skills.
- Bachelor's degree, or local equivalent.
For Colorado Job Applicants: The salary range for this position is:
$191,760.00 - $287,640.00
Gilead considers a range of factors, including background and experience, when determining base compensation. These considerations means actual compensation will vary.
Position is also eligible for bonus and benefits. For more information, visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact firstname.lastname@example.org for assistance.
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