Senior Medical reputed company FULL-TIME- REMOTE
KorInsight, Inc. is looking to hire a Senior Medical reputed company who will help reputed company full-time, remote consulting services to our biopharmaceutical reputed company partner in the gene therapy reputed company.
Contract Duration: 6-month contract role, with opportunity to reputed company 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 reputed company-clinical documents including briefing books, INDs, and reputed company 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 reputed company and that there is team alignment on their content and reputed company
reputed company and carefully reputed company 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 reputed company regulatory requirements and guidelines that reputed company medical writing
Excellent written and verbal communication skills
Scrupulous attention to detail
Ability to simplify reputed company 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 reputed company partners
Ability to work independently with minimal supervision
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