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Manager, Medical Writing

Gilead Sciences

$230,330.00 per year

Full-time

1530 NW 57th St

Seattle, WA 98127

For Current Gilead Employees and Contractors:

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 at Gilead.

Management Responsibility

  • May manage direct reports and may mentor and train less experienced writers.

Project Involvement

  • Participates in submission teams, regulatory project teams (RPTs), or other teams, with occasional guidance from a more senior writer for complex projects or strategic issues.

Key Differentiating Contributions

  • Has in depth understanding of industry regulations, Gilead standards, and medical writing processes and tools.
  • Understands the medical writer s role at Gilead as well as the potential for contributions of individual team members. Provides project teams with direction and strategic input on regulatory document timelines at a program or multi-document level. Uses appropriate judgement in determining issues that require negotiation and appropriately involves other team members or medical writing management in problem resolution.
  • Independently authors clinical study reports (CSRs) of all study phases, investigator brochure (IBs) updates, and other core medical writing deliverables. Authors high complexity documents such as integrated CTD summaries or pediatric investigation plans (PIPs) with some input from a more senior writer.
  • Can train others on document management and authoring tools. Has understanding of the publishing tools used for regulatory submissions.
  • Is highly proficient at technical writing. Can analyze data produced for assigned documents and effectively summarize key points without specific direction from other team members.
  • Performs other tasks pertinent to authoring of assigned documents, such as reviews of timelines, statistical analysis plans, table shells, and draft data tables. Has depth of scientific, regulatory, and medical writing practices knowledge to enable flexible transition across programs or therapeutic areas in times of departmental resource constraints.

Job Responsibilities and Skills

  • Independently prepares regulatory documents such as CSRs and IBs according to regulatory requirements and internal Gilead document standards. Noncritical documents are prepared with minimal supervision from a senior writer.
  • Authors more complex regulatory documents (eg, CTD summaries, PIPs, regulatory responses) with some direction from team leaders or a more senior writer.
  • Contributes to other non-regulatory medical writing activities as required.
  • Participates in cross-functional submission teams, RPTs, or other teams, with occasional guidance from a more senior writer for complex projects or strategic issues.
  • Leads document timeline/resource planning for assigned projects within the submission team.
  • Works collaboratively with functional contributors (clinical, biometrics, virology etc), ensuring all source information / 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 contributed to assigned documents from other functions such as Clinical Research, Biometrics, and Regulatory.
  • Contributes to development work in relation to document standards, template development, and other aspects of document management.
  • Demonstrated success in the independent preparation of regulatory documents, particularly at the individual study report level.
  • Excellent verbal communication skills. Can effectively communicate with a variety of teams and individuals, including team leadership and members of senior management staff. Shows flexibility in communication style to work effectively with a variety of team members.
  • Knowledgeable of regulatory document requirements/guidelines with direct experience in a wide variety of regulatory document types.
  • Well developed computer skills including proficiency in Word, Adobe, Excel, and the Regulatory Document Management System.
  • Attends and participates in routine departmental meetings.

Typical Education and Experience

  • Typically requires a BS degree and a minimum of 7 years of relevant experience within clinical R&D or regulatory affairs such as pharmaceuticals/biotechnology, including a minimum of 4 or more years of relevant experience in a medical writing/clinical submissions environment directing/preparing documents for regulatory submissions.

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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.


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