Role and Responsibilities:
- Act in the capacity of project manager for medical writing projects. This may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues.
- Serve as the Medical Writing representative on assigned project teams, providing proactive support to CDM for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Identify any potential project challenges, including changes in the project plan, timeline, or out-of-scope requests, and suggest possible resolution options.
- Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review.
- Ensure document content and style adhere to ICH/FDA/EMEA or other appropriate regulatory guidelines, and comply with departmental and corporate or client SOPs and style guidelines.
- Coordinate and conduct interdivisional team review and sign-off of document deliverables including: distributing drafts, chairing review meetings, incorporating revisions, documenting key project events, and completing sign-off.
- Coordinate production and distribution of draft and final documents to DOM and client. Ensure that all work is complete and of high quality before team distribution or shipment to the client.
- Perform literature searches/reviews as necessary to obtain background information and training for the development of documents.
- Review statistical analysis plans to assist in determining the appropriateness of content/format for clinical writing.
- Attend internal technical team and client team meetings as required.
- Provide training and guidance and act as a mentor to less experienced departmental members.
- Ensure proper collection of materials for the assembly of client deliverables and filing appropriately in the department project files.
- Assist management as needed with the preparation of resourcing estimates for potential new medical writing projects.
- Assist management as needed in reviewing requests for proposal packages sent by clients to determine the content and appropriateness of materials required for the development of clinical documents.
- Initiate and participate in departmental or interdivisional process improvement and training initiatives.
- Initiate and manage the development of formats, templates, and general guidelines for clinical documentation and workflow procedures.
- Assist in the development of departmental SOPs.
- Respect for the Company's Values and Code of Ethics.
Qualifications and Skills:
- B.Sc. in Medicine or Pharmacy.
- 4 years of experience in medical writing.
- Familiarity with the fundamentals of biostatistics.
- Knowledge of FDA and ICH guidelines for clinical trials.
