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Sr. Medical Writer

Remote, CA remote

Posted: 09/15/2023 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 561866 Is job remote?: Yes Country: United States

Job Description

Job Responsibilities:
  • Independently or with minimal supervision write, edit, perform data verification, submit for review, and obtain approval for clinical and nonclinical regulatory documents including, but not limited to, clinical protocols, clinical study reports (CSRs), investigator's brochures, summary document, and safety reports
  • Perform copy editing for grammar, punctuation, style, and internal consistency
  • Collaborate effectively with other functional area authors to achieve submission schedules as prioritized by senior management
  • Administer QC checks to ensure documents comply with FDA guidelines
  • Help develop and manage medical writing processes, SOPs, and templates for key documents
  • Help manage the functional review of study documents produced by other contract writers
  • Keep abreast of professional information and technology through literature, symposia, and conferences
  • Participate in departmental and cross-departmental initiatives. Provide innovation and be a resource for improving departmental processes.
  • Provide expertise and guidance on document design and principles of good medical writing to department and product teams
  • Experience writing protocols from the design phase

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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