Medical Writing Manager (REMOTE)

  • Freelance
  • Remote

The Fountain Group


My name is Kelli and I am a Recruiter with The Fountain Group. We are a national staffing firm and are currently seeking a Medical Writing Manager for a prominent client of ours. This position is Marlborough, MA. Details for the position are as follows:

Job Description:

· Accountable for the timely delivery of high quality regulatory submission documents.

· Lead the medical writing activities for one or more therapeutic areas or clinical development programs.

· Develop strategic medical writing plans in order to meet clinical program objectives.

· Provide management and oversight of medical writing staff to ensure regulatory submission documents are developed in accordance with medical writing plans.

· Develop strategic medical writing plans in accordance program and/or project objectives. Plans are developed in accord with applicable guidelines (ICH, CFR, etc.) and with adherence to company’s templates and SOPs.

· Determine resource requirements to meet regulatory submission document deliverable milestones and timelines in accordance with medical writing plans.

· Manage and provide mentorship and guidance to Medical Writing staff (internal/external) to ensure document development activities are performed in accordance with medical writing plans

· Provide senior level review of regulatory submission documents prepared by Medical Writing staff (internal/external).

· Author and review documents for regulatory submissions (protocols, investigator brochures, clinical study reports, and IND and NDA summary documents) in support of the clinical development lifecycle and program goals for one or more clinical development programs.

· Drive document strategies and messages to relevant subject matter experts to ensure appropriate, factual and concise presentation of assigned documents.

If you are interested in hearing more about the position please respond to this posting with your resume attached.