Our portfolio of 14 marketed products includes a number of category firsts, including the only complete treatment regimens for HIV infection available in a once-dailysingle pill -- Atripla? (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), approved in 2006, and Complera?, approved in 2011.
Associate Director, 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
* 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.
* Demonstrated leadership of complex Medical Writing projects, including oversight of the contributions of other writers.
* Recognized as a resource within the function and a regulatory writing subject matter expert for project teams as well as the primary point of contact for cross-functional groups.
* Contributes to other non-regulatory medical writing activities as required.
* Participates in submission teams and provides advice/guidance for content and optimal presentation of data for achievement of document and submission objectives.
* Utilizes strong operational and management skills to ensure the Medical Writing function is achieving their strategic goals. This includes contributing to overall resource and prioritization planning for the Medical Writing department.
* 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.
* Manages and supervises the work of internal medical writers as well as external contractors to ensure the highest quality of medical writing and adherence to Gilead document standards.
* Leads the compilation of final documents and appendices coordinating clinical, biometrics and regulatory contributions.
* Leads group initiatives in relation to document standards, continuing MS template development, cross-functional processes, and other aspects of document management. Proactively identifies areas for process improvement initiatives within Medical Writing.
* Demonstrated experience in the preparation of regulatory documents, specifically critical CTD summaries for significant regulatory submissions and regulatory responses.
* Excellent medical writing and 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.
* 12+ years of experience with a BA degree.
* 10+ years of experience with an MS degree.
* 6+ years of experience with PhD, MD or DVM.
* 10+ 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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