Senior Medical Writer FULL-TIME- REMOTE

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:
?? Write, review, and edit clinical regulatory documents such as study synopses, clinical study protocols, clinical study reports (CSRs), interim analyses, etc
?? Write, review, and edit regulatory and pre-clinical documents including briefing books, INDs, and related collateral documents
?? Critically assess and interpret statistical and clinical data
?? Help prepare for meetings with regulatory agencies
?? Work closely with cross-functional teams to ensure documents are high quality and that there is team alignment on their content and progress
?? Develop and carefully track timelines for document submission
?? Contribute to the development and implementation of medical writing best practices, policies, and SOPS to improve standards for authoring, reviewing, and finalizing documents

Qualifications
?? 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
?? Familiarity with current regulatory requirements and guidelines that affect medical writing
?? Excellent written and verbal communication skills
?? Scrupulous attention to detail
?? Ability to simplify complex information and present it in an engaging manner
?? Exceptional work ethic and organizational, time, and project management skills
?? Ability to foster relationships, build alignment, negotiate, and collaborate with cross-functional client partners
?? Ability to work independently with minimal supervision

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