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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