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.
Apply Now
Apply Now
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 Now
Apply Now