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Apex Life Sciences

Medical Writer - clinical protocols, study reports

Post Date:Jan 01, 2018Type:Contractor
Start Date:1/1/2018Salary:
Location:US-NJ-Basking ridge Job Reference:804620

Job Description:


  • Writes Phase 2-3 clinical protocols and study reports with guidance from study team members and senior medical writing personnel
  • Organizes and leads meetings with study team members to determine timelines and processes for protocol and study report development. 
  • Liaises with QC department to ensure quality control of documents.  Organizes and prepares cover sheets for report appendices.
  • Edits Phase 2-3 clinical protocols and study reports, NDA submission documents, and SOPs; Ensures key messages are clear and consistent; Adheres to house style guide for formatting and usage
  • Manage documents through the review process (coordinating document review meetings, collate and reconcile comments from various functional groups) and the approval process; Assist document approvers with using Documentum to provide electronic signatures
  • Writes clinical sections of investigator brochures and assembles nonclinical and CMC sections; Organizes and leads meetings with project team members to determine timelines and processes for IB development; Uses data from clinical study reports to update clinical sections of IB; Interacts with colleagues in Asia regarding updates to nonclinical section; Liaises with QC department to ensure quality control of IB
  • Provide independent document quality control services for documents on which the writer has no other role; Check electronically published CSRs for completeness (appendices and required signatures present) and adherence to company’s electronic publishing standards before archiving
  • Interacts with and supports CRO medical writers by communicating company standards, processes, templates, timelines, etc.


  • Bachelor’s Degree in Life Sciences or related field required; Master’s degree in Science preferred
  • 2+ years of experience in medical writing required
  • Knowledge of clinical development and clinical, medical, and regulatory writing a must
  • Experience with hands-on writing, coordination of document reviews, and document quality control (QC) for documents produced by other writers desire
  • Ability to ensure that documents are of high quality in terms of scientific content, organization, clarity, accuracy, format and consistency, and adherence to regulatory requirements and company guidelines, styles, and processes. 
  • Must edit NDA submission documents, edit SOPs, and interact with and support CRO medical writers.

**For immediate consideration, please email your updated resume to [Click Here to Email Your Resumé] with 'Medical Writer' in the subject line.

Contact Information
Apex Life Sciences

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