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Position Overview:
We are looking for a Senior Manager or Manager in Medical Writing to oversee the development of clinical regulatory documentation supporting drug development and regulatory filings. This role will focus on writing, revising, and managing high-quality materials while providing guidance and leadership to ensure that documents meet regulatory standards.
Core Responsibilities:
- Direct the creation and editing of clinical regulatory documents, including submission summaries and other essential materials for drug development and regulatory submissions.
- Ensure all documents are precise, thorough, and in compliance with regulatory guidelines and best practices.
- Lead and manage teams of internal staff, contingent workers, and vendors, providing strategic direction and support.
- Contribute to the creation of document templates and process enhancements to improve efficiency and document quality.
- Work closely with cross-functional teams to ensure all regulatory documentation aligns with submission requirements and standards.
Required Qualifications:
- A PhD, PharmD, or Master’s degree in Life Sciences or a closely related field.
- For the Manager role: A PhD/PharmD with 2+ years of experience or a Master’s with 4+ years of experience in regulatory medical writing.
- For the Senior Manager role: A PhD/PharmD with 4+ years of experience or a Master’s with 6+ years of experience in regulatory medical writing.
- Expertise in Microsoft Word and proficiency in document preparation tools and electronic formats.
- In-depth experience in regulatory writing with a solid understanding of global submission requirements and regulatory standards.
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Writing/Editing
Industries: Pharmaceutical Manufacturing and Biotechnology Research
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