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
Apply Now
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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
Apply Now
For more such jobs please click here!