Sr Director, Global Regulatory Medical Writing & Data Transparency
Posted 2025-08-15
Remote, USA
Full Time
Immediate Start
About the position
The Senior Director of Global Regulatory Medical Writing & Data Transparency at Teva Pharmaceuticals is responsible for leading a team of medical writers and electronic document specialists. This role focuses on producing high-quality clinical research documentation that adheres to regulatory guidelines and supports drug development and product registrations. The position requires strategic vision and planning at a global level, ensuring optimal resource use and providing mentorship to manager-level direct reports.
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. Apply tot his job
The Senior Director of Global Regulatory Medical Writing & Data Transparency at Teva Pharmaceuticals is responsible for leading a team of medical writers and electronic document specialists. This role focuses on producing high-quality clinical research documentation that adheres to regulatory guidelines and supports drug development and product registrations. The position requires strategic vision and planning at a global level, ensuring optimal resource use and providing mentorship to manager-level direct reports.
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. Apply tot his job