Our client is currently seeking a SENIOR MEDICAL WRITER. This individual has responsibility for the preparation of clinical documents such as Investigator Brochures (IBs), protocol synopses and protocols, clinical study reports (CSR), narratives, integrated summary documents, clinical portions of INDs NDAs, ANDAs as well as SOPs. The Senior Medical Writer is an integral part of the development of processes and templates for clinical documents.

This job will have the following responsibilities:
  • Duties may include planning, writing, editing, and reviewing of clinical documents including but not exclusive to IBs, protocol synopses, protocols (Phase 1-3), clinical study reports (CSRs), narratives, as well as the review and revision of SOPs.
  • Manages review and approval workflows in SharePoint and the electronic document management system (EDMS).
  • Contributes to establishing vendor requirements for medical writing needs. Serves in an oversight capacity for outsourced medical writing deliverables.
  • Ensures document quality, compliance with SOPs and reviews clinical documents for consistency with company style guide, FDA, CTD, and other regulatory guidelines.
  • Collaborates with document project team members to establish timelines and priorities
  • Conducts document Kick-Off-Meetings (KOMs) and facilitates cross-functional document review meetings (e.g., Protocol Review Committee (PRC), CSR review meetings, etc.)
  • Participates in process improvements and enhancement of templates for the medical writing function.
  • Acts as the CSR Coordinator. Tracks and ensures final clinical study reports deliverables (report body, appendices and data files) are complete for publishing output.
Qualifications & Requirements:
  • Education:
    • PhD degree preferred in a scientifically-related area. Master’s degree required. If no Master’s degree, equivalent work experience will be considered.
  • Experience:
    • Minimum of 5-8 years experience in the writing of medical documents (IBs, protocols, CSRs) including working in a multifunctional team environment.
  • Preferred Skills/Qualifications:
    • Demonstrated leadership and collaboration abilities
    • Ability to effectively handle conflict through proactive action and direct and timely communication
    • Demonstrated attention to detail and experience to check behind the scenes to ensure documents contain the appropriate content.
    • Knowledge of FDA Pharmaceutical Guidelines and Common Technical Document (CTD) format
    • Strong organizational and planning skills
    • Excellent interpersonal skills with demonstrated ability to work in a team environment and to interact effectively with people at many levels of the organization
    • Experience in assembling scientifically complex data or information to develop documents such as a clinical trial final study report, clinical trial protocol, or other specific document for regulatory submission.
    • Preference will also be given to candidates that have worked across multiple study Phases (Phases I, II and III) and who have had submission experience.
  • Additional Skills/Competencies:
    • Excellent oral and written communication skills along with ability to listen effectively to others
    • Skilled in problem identification and solving, including ability to negotiate and influence
    • Previous experience in the participation and preparation of clinical documents for regulatory submission (e.g. clinical protocols, INDs) is a must
    • Proficient in the MS Office Suite with expertise in MS Word and prior experience using and Adobe Acrobat and SharePoint. Experience with MS Project is preferred.


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