Job Description
KorInsight, Inc. is looking to hire a Senior Medical Writer who will help provide full-time, remote consulting services to our biopharmaceutical client partner in the gene therapy space.
Contract Duration: 6-month contract role, with opportunity to extend or convert to FTE
Weekly Hours: 40
Responsibilities will include but are not limited to the following:
Ā Write, review, and edit clinical regulatory documents such as study synopses, clinical study protocols, clinical study reports (CSRs), interim analyses, etc
Ā Write, review, and edit regulatory and pre-clinical documents including briefing books, INDs, and related collateral documents
Ā Critically assess and interpret statistical and clinical data
Ā Help prepare for meetings with regulatory agencies
Ā Work closely with cross-functional teams to ensure documents are high quality and that there is team alignment on their content and progress
Ā Develop and carefully track timelines for document submission
Ā Contribute to the development and implementation of medical writing best practices, policies, and SOPS to improve standards for authoring, reviewing, and finalizing documents
Qualifications
Ā Advanced degree (M.S.) in relevant scientific discipline, Doctoral level degree (Ph.D., Pharm.D., or M.D.) preferred with minimum of 3-5 years of scientific or medical writing experience at a biotech/pharmaceutical company
Ā Familiarity with current regulatory requirements and guidelines that affect medical writing
Ā Excellent written and verbal communication skills
Ā Scrupulous attention to detail
Ā Ability to simplify complex information and present it in an engaging manner
Ā Exceptional work ethic and organizational, time, and project management skills
Ā Ability to foster relationships, build alignment, negotiate, and collaborate with cross-functional client partners
Ā Ability to work independently with minimal supervision
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