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Please log onto your Internal Career Site to apply for this job.Job Description
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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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.