Manager, Regulatory Medical Writing
Manager, Regulatory Medical Writing
United States - Washington - Seattle
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
The Medical Writing department resides organizationally within Regulatory Documentation and Submissions (RDS) at Gilead. The Medical Writing department works to advance the strategy and creation of high-quality documents to support efficient and successful regulatory submissions across all regions.
The Manager of Medical Writing prepares scientific/regulatory documentation to support regulatory submissions. Plans and has oversight for medical writing deliverables for small clinical/regulatory submissions
- Authors clinical/regulatory documents such as CSRs of all phases and IBs according to regulatory requirements and internal Gilead document standards with limited oversight of a more senior writer
- Performs medical writing activities at the level of single study reports and noncritical documents with minimal supervision. May work in tandem with a more senior writer on other documents types such as integrated CTD summaries, PIPs, or regulatory responses
- Contributes to other nonregulatory medical writing activities as required
- May represent Medical Writing on cross-functional project teams with input or supervision of a more senior writer. May participate in regulatory submission teams, providing advice/guidance to the team on regulatory document requirements or on optimal presentation of data for achievement of document objectives
- May lead document timeline/resource planning within the submission team with input from a more senior writer for complex timeline/resource issues that span multiple document deliverables
- Works collaboratively with functional contributors (Clinical Research, Biometrics, Virology etc.), ensuring all source information and data are appropriately reported in terms of accuracy, completeness and scientific interpretation, and in accordance with project timelines
- Coordinates the compilation of final documents and appendices that are provided by other functions
- Contributes to development work in relation to document standards, continuing template development, and other aspects of document management
- Attends and participates in routine departmental meetings
Knowledge and skills:
- Demonstrates success in the preparation of clinical/regulatory documents particularly at the individual study report level
- Excellent verbal communication skills, can effectively communicate with a variety of teams and individuals
- Knowledgeable of regulatory document requirements/guidelines
- Well-developed computer skills including proficiency in Word, Adobe, Excel, and the Regulatory Document Management System
Education and experience:
- BA/BS and 7+ years of relevant experience (less with advanced degree)
- Relevant experience includes clinical R&D, regulatory affairs, or related industry/academic experience, with 3+ years of direct experience preparing clinical/regulatory documents in a medical writing/clinical submissions environment.
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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 email@example.com for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
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