
Global Regulatory Lead
1 day ago
Job Title: Global Regulatory Writing Leader
About the Role:
We are seeking a professional to oversee the preparation and review of scientific and regulatory submission documents. The successful candidate will serve as a functional area lead on product teams, maintain key business relationships with cross-functional team members, and provide expertise in document design and principles of good medical writing.
The ideal candidate will supervise, train, and mentor regulatory writers, oversee contract writers and CROs, and manage day-to-day departmental activities. Additionally, they will assist executive leadership with resource planning and other department management activities.
Key Responsibilities:- Oversight of scientific and regulatory submission documents
- Leadership of product teams and cross-functional team members
- Expertise in document design and good medical writing principles
- Supervision, training, and mentoring of regulatory writers
- Overseeing contract writers and CROs
- Management of day-to-day departmental activities
- Assistance with resource planning and department management activities
- A Doctorate degree and 4 years of directly related experience OR
- A Master's degree and 8 years of directly related experience OR
- A Bachelor's degree and 10 years of directly related experience
- Experience reading, understanding, and applying regulations to a constantly changing environment
- Proven leadership skills with motivation, negotiation, persuasion, collaboration, and analytical judgment
- Expertise in analyzing scientific data and interpreting its significance
- Excellent written and oral communication skills and attention to detail
- SUPERIOR time and project management skills
- A self-starter with perseverance and a drive for results
- Strong management and supervisory skills with previous experience developing and delegating to direct reports
- Advanced knowledge of scientific writing and editing and the clinical development process
- Advanced knowledge of related regulatory/industry considerations and guidelines
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