Senior Manager Medical Writing
Company: Ascent Services Group
Location: San Diego
Posted on: April 8, 2021
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Job Description:
We are seeking talented individuals who will thrive in our
collaborative, diverse, fast-paced environment and share in our
mission to identify, develop and deliver life-changing therapies to
people living with rare disease. We stick by our values centered on
patients, courage, community, and collaboration to pursue our
vision of becoming a leading biopharmaceutical company dedicated to
the delivery of innovation and hope to patients in the global rare
disease community.
Position Summary:
The Senior Manager, Medical Writing is responsible for oversight
and authoring (if needed) of regulatory, clinical, and safety
documents, including protocols and amendments, clinical study
reports (CSRs), Investigator's Brochures (IBs), Common Technical
Document (CTD) sections, and Periodic Safety Update Reports
(PSURs). This position is expected to contribute directly to the
drafting of high level (eg, Module 2) submission documents and be
responsible for overall project management during the drafting,
reviewing, and approving cycles of documents. This position will
oversee the drafting of documents that are compliant with
company-specific medical writing standards, are completed on-time
and on-budget, and are ready for submission to global, regional,
and local regulatory authorities. Additionally, this position will
support projects across all phases of clinical development and
post-marketing life cycle management.
Essential Functions:
1001 Galaxy Way, Suite 405
Concord, CA 94520
925-627-4900
info@ascentsg.com Employment Verifications
Via The Work Number, employer code 105779 Additional office
locations in Chico, CA; Chicago, IL; Los Angeles, CA.
Keywords: Ascent Services Group, San Diego , Senior Manager Medical Writing, Healthcare , San Diego, California
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