Gilead Sciences, Inc. Associate Director, Medical Writing in Foster City, California

For Current Gilead Employees and Contractors:

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

Job Description

Job Overview/Summary

The Medical Writing department resides organizationally within Regulatory Documentation and Submissions 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.

Prepares scientific/regulatory documentation to support regulatory submissions. Plans and has oversight for medical writing deliverables for a wide variety of large complex clinical/regulatory submissions.

Job Responsibilities

  • Independently authors a wide variety of clinical/regulatory documents of all types and complexities (eg, CSRs, IBs, CTD summaries, PIPs, and regulatory responses). Ensures appropriate and effective collaboration with key functional contributors and that all documents are authored according to regulatory requirements, and internal Gilead document standards, with adherence to timelines and team expectations.

  • May serve as an effective filing lead for a large complex regulatory submission, which includes development and management of document timeline and resource planning for assigned projects.

  • As a submission lead, influences the identification of key document messages and supporting data for delivery of target labels and to minimize regulatory questions. Can develop solutions for the optimal organization and presentation of information to achieve the submission objectives in accordance with requirements and guidance for clinical/regulatory documents with minimal input.

  • May serve as a lead medical writer and department representative for a large development program or therapeutic area, including providing guidance to less experienced writers or contract medical writers working on the projects they manage.

  • Participates on multiple crossfunctional teams (eg, regulatory submission teams, regulatory project teams) and provides guidance on regulatory submission document strategies.

  • May represent Medical Writing on crossfunctional initiatives/teams supporting key RDS or Regulatory Affairs objective.

  • Participates in or may lead medical writing and crossfunctional process improvement initiatives on clinical document standards, template development, and document processes.

  • Coaches, trains, and provides guidance to less experienced writers or contract medical writers. Leads or advises others on complex projects or problems with broad impact and reviews documents written by less experienced or contract medical writers.

Knowledge & Skills

  • Excellent verbal communication, technical writing, and project management skills

  • Demonstrates success in the preparation of complex clinical/regulatory documents at the individual study report and submission level.

  • Expert knowledge of industry regulations, regulatory documentation requirements, and Gilead medical writing processes and standards

  • Effectively facilitates communication with a variety of individuals, including team/functional leadership and members of senior management

  • Provides leadership and has ability to influence, negotiate, and collaborate within a crossfunctional team environment

  • Facilitates issue resolution and collaborates with crossfunctional teams through processes of moderate complexity given clear direction

  • Medical writing subject matter expert for clinical/regulatory documents and submissions of medium to high complexity

  • Well-developed computer skills including proficiency in Word, Adobe, Excel, and the Regulatory Document Management System

Education & Experience

BA/BS and 10+ years of relevant experience (less with advanced degree)

Relevant experience includes clinical R&D, regulatory affairs, or related industry/academic experience, with 5+ years of direct experience in a medical writing/clinical submissions environment directing/preparing documents for regulatory submissions.

Meet the team:

https://regulatoryaffairs-careers.gilead.com/

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About Gilead:

Gilead Sciences, Inc. is a research-based biopharmaceutical 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. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

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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 careers@gilead.com for assistance.

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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:

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

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises 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. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community at http://gilead.avature.net/Gilead