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Senior Manager, Medical Writing
Ref No.: 18-13493
Location: Marlborough, Massachusetts
A Senior Manager, Medical Writing is accountable for the timely delivery of high quality regulatory submission documents. A Senior Manager, Medical Writing will lead the medical writing activities for one or more therapeutic areas or clinical development programs. A Senior Manager, Medical Writing develops strategic medical writing plans in order to meet clinical program objectives. A Senior Manager, Medical Writing provides management and oversight of medical writing staff to ensure regulatory submission documents are developed in accordance with medical writing plans.
Essential Functions Required for Job
The essential functions should describe the key responsibilities of the position in concise, comprehensive statements and address what the employee does to achieve the position's main purpose. Please indicate the approximate percentage of time spent on each essential function.

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 Sunovion 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.