Senior Manager, Medical Writing (Bay Area, California)

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Since 1987, Gilead Sciences has worked to discover, develop and commercialize medications to advance the care of patients suffering from life-threatening diseases in areas of unmet medical need.

In just over 20 years, Gilead has become a leading biopharmaceutical company with a portfolio of 14 marketed products, a growing pipeline of investigational drugs and approximately 4,500 employees in offices across four continents.
Gilead's therapeutic areas of focus include HIV/AIDS, hepatitis, serious respiratory, cardiovascular, and metabolic conditions, cancer and inflammation.

Senior Manager, Medical Writing

Specific Responsibilities
The Medical Writing function resides organizationally within Regulatory Affairs at Gilead and provides scientific/regulatory writing services to support clinical trial reporting as well as a wide variety of regulatory submissions across antiviral, respiratory, cardiovascular and oncology indications.

This position is responsible for working with Gilead project teams across sites to produce complex clinical documents for global regulatory submissions, including clinical summaries and overviews, clinical study reports (CSRs), investigator brochures, pediatric investigational plans (PIPs), clinical trial results postings (ClinicalTrials.gov), and other key clinical and regulatory documents.

* Is able to prepare a wide variety of regulatory documents independently or with minimal supervision
* Writes multi-study summary documents for pivotal studies
* Writes sections of product approval applications and other submissions
* Works with Biometrics on clinical data interpretation
* Reviews and prepares FDA briefing packages
* Serves as a cross-functional resource
* Can facilitate issue resolution and lead multi-functional teams with clear direction through complex processes

Essential Duties and Job Functions
* Demonstrated ability to prepare a wide range of regulatory documents, such as clinical study reports and Investigator Brochures, as well as CTD summaries, pediatric investigational plans [PIPs], and regulatory responses, in-line with regulatory requirements and Gilead internal document standards, and without appreciable supervision.
* Contributes to other non-regulatory medical writing activities as required.
* Participates in submission teams and provides advice/guidance for optimal presentation of data for achievement of document objectives.
* 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.
* Performance management may be required.
* Leads the compilation of final documents and appendices coordinating clinical, biometrics and regulatory contributions.
* Leads/contributes to development work in relation to document standards, continuing MS template development, and other aspects of document management. Proactively identifies areas for process improvement initiatives within Medical Writing.
* Demonstrated success in the independent preparation of regulatory documents, particularly at the individual study report level.
* Excellent verbal communication skills.
* Knowledgeable of regulatory document requirements/guidelines.
* Well developed computer skills including proficiency in Word, Adobe and Excel

Knowledge, Experience, and Skills
Typically requires a BS degree and minimum 10 years of relevant experience within clinical R&D or regulatory affairs such as pharmaceuticals/biotechnology which includes 5+ years of relevant experience in a medical writing/clinical submissions environment directing/preparing documents for regulatory submissions.

* 10+ years of experience with a BA degree.
* 8+ years of experience with an MS degree.
* 4+ years of experience with PhD, MD or DVM.
* 5+ years in medical writing or the clinical submissions environment preparing documents for regulatory submissions.

To apply for the position, please click here.

Gilead is an equal opportunity employer.

Location: Bay Area, CaliforniaPrincipals only. Recruiters, please don't contact this job poster.Please, no phone calls about this job!Please do not contact job poster about other services, products or commercial interests.

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