Sr Director, Global Regulatory Medical Writing & Data Transparency
About the position
- Responsibilities
- Provide leadership and direction to a team of medical writers and electronic document specialists.
- Ensure the production of high-quality clinical research documentation in compliance with regulatory guidelines.
- Serve as a liaison among internal functional groups to optimize medical writing support for projects.
- Mentor and develop manager-level direct reports in regulatory medical writing processes and standards.
- Requirements
- PhD in life sciences or related field with a minimum of 10 years of experience in medical writing, or a Master's degree with a minimum of 15 years of experience.
- Expertise in setting regulatory medical writing processes and technical standards.
- In-depth knowledge of global regulations and guidelines for document submissions.
- Proven experience in clinical drug development and regulatory medical writing.
- Nice-to-haves
- Experience in a leadership role within a global function.
- Strong communication and interpersonal skills to liaise with various stakeholders.
- Benefits
- Comprehensive Health Insurance (Medical, Dental, Vision, and Prescription coverage).
- 401(k) with employer match and annual Defined Contribution.
- Paid Time Off including vacation, sick time, caretaker time, and paid holidays.
- Company paid Life and Disability insurance.
- Employee Assistance Program and Employee Stock Purchase Plan.
- Tuition Assistance and Flexible Spending Accounts.
- Paid Parental Leave and Family Building Benefits.
- Virtual Physical Therapy and various insurance options.
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