Manager, Medical Writing at Sunovion
Manager, Medical Writing
- Location: US National – Remote
Sunovion Pharmaceuticals is looking for a Manager, Medical Writing to join our Global Regulatory Affairs organization (Anywhere in the US).
A Manager, Medical Writing is accountable for the timely delivery of high quality regulatory submission documents that are aligned with strategic medical writing plans. A Manager, Medical Writing will lead the medical writing activities for one or more therapeutic areas or clinical development programs. A Manager, Medical Writing may provide management and oversight of contract medical writing staff to ensure regulatory submission documents are developed in accordance with medical writing plans.
- Author and review documents for regulatory submissions (protocols, investigator brochures, clinical study reports, and IND and NDA summary documents) that are aligned with medical writing plans that support the clinical development lifecycle and program goals for one or more clinical development programs.
- Negotiate document deliverable milestones and timelines with cross-functional teams to ensure alignment with teams and with medical writing plans.
- Drive document strategies and messages to relevant subject matter experts to ensure appropriate, factual and concise presentation of data for assigned documents.
- Manage and provide oversight of external/contract Medical Writers 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).
Minimum Education, Experience, Knowledge and Skills:
- Bachelor’s degree required; advanced degree (Master’s or Ph.D) in science desired.
- 3-5 years medical writing experience, including writing and review of documents to support the clinical development life-cycle from IND to NDA and beyond.
- Some management/mentorship of medical writers (either internal or external writers).
- Experience representing medical writing on cross-functional teams.
- Experience with automated document templates and AMA style guide.
- Knowledge of FDA and/or EMEA regulations, GCP, ICH guidelines and familiarity working according to established GCP standard operating procedures.
- Strong interpersonal and teamwork skills.
- Excellent oral and written communication skills.
- Strong analytical and organization skills and a high attention to detail.
- Strong working knowledge of Adobe PDF, MS WORD, EXCEL, PowerPoint, and Project.
Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sunovion are carried out with the “best” industry practices and the highest ethical standards.
Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
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