Manager, Medical Writing
Company: Gilead Sciences, Inc.
Location: Oceanside
Posted on: January 12, 2021
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Job Description:
Manager, Medical Writing United States - California - San Diego
Gilead Sciences, Inc. is a research-based bio-pharmaceutical
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. Making an impact on a global scale
Inclusion is one of the company---s five core values. That---s
because we know that we are stronger and more innovative at Gilead
when we are informed by a diverse set of backgrounds, experiences
and points of view. Gilead Sciences is a biopharmaceutical company
that discovers, develops and commercializes innovative therapeutics
in areas of unmet medical need. The company's mission is to advance
the care of patients suffering from life-threatening diseases
worldwide. When you join Gilead, you join our mission to change the
world by enabling people to live healthier and more fulfilling
lives. Come join a mission-driven bio-pharmaceutical organization
that values inclusion and diversity, has a strong portfolio of
products, and is constantly CreatingPossible 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. Job summary: 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 Job
responsibilities: 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. For jobs in the United
States: 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 careersgilead.com for
assistance. For more information about equal employment opportunity
protections, please view the ---EEO is the Law' poster. NOTICE:
EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND
MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION 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.
Keywords: Gilead Sciences, Inc., Oceanside , Manager, Medical Writing, Executive , Oceanside, California
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