Associate Director, Medical Writing
Teva Pharmaceuticals
4 hours ago
Remote friendly (West Chester, PA)
United States
Clinical Research and Development
Associate Director, Global Regulatory Medical Writing
Responsibilities:
- Lead the development, writing, and critical review of clinical regulatory documents across all document types, ensuring high quality, consistency, and compliance with global regulatory requirements.
- Provide functional leadership and oversight to medical writers, offering guidance, review, and mentoring to support delivery excellence and professional development.
- Serve as a recognized internal subject matter expert in regulatory medical writing and clinical drug development, advising cross-functional stakeholders on strategy, content, and standards.
- Apply deep therapeutic area knowledge and statistical concepts to interpret clinical data and translate it into clear, accurate regulatory narratives.
- Drive best practices, quality standards, and continuous improvement within the medical writing function for efficient and compliant document development.
- Act as a trusted partner to clinical, regulatory, and project teams to enable timely, high-quality submissions and successful regulatory outcomes.
Qualifications:
- Master’s degree with a minimum of 8 years OR PhD/PharmD with a minimum of 6 years of relevant experience.
Skills / Required:
- Excellent command of English (written and spoken).
- Ability to formulate regulatory medical writing strategies under guided supervision.
- Strong judgment and decision-making in complex and ambiguous situations.
- Strong communication and influencing skills.
- Negotiation and stakeholder-management skills.
- Knowledge of global guidelines and regulations relevant for Regulatory Medical Writing.
Also Good to Have:
- Experience with technical and digital advancements in regulatory medical writing.
- Experience in vendor oversight.
Benefits (explicitly listed):
- Comprehensive Health Insurance (Medical, Dental, Vision, Prescription)
- Retirement Savings (401(k) with employer match)
- Paid Time Off
- Company paid Life and Disability insurance
Application instructions:
- Apply through the internal career site on Twist.
Responsibilities:
- Lead the development, writing, and critical review of clinical regulatory documents across all document types, ensuring high quality, consistency, and compliance with global regulatory requirements.
- Provide functional leadership and oversight to medical writers, offering guidance, review, and mentoring to support delivery excellence and professional development.
- Serve as a recognized internal subject matter expert in regulatory medical writing and clinical drug development, advising cross-functional stakeholders on strategy, content, and standards.
- Apply deep therapeutic area knowledge and statistical concepts to interpret clinical data and translate it into clear, accurate regulatory narratives.
- Drive best practices, quality standards, and continuous improvement within the medical writing function for efficient and compliant document development.
- Act as a trusted partner to clinical, regulatory, and project teams to enable timely, high-quality submissions and successful regulatory outcomes.
Qualifications:
- Master’s degree with a minimum of 8 years OR PhD/PharmD with a minimum of 6 years of relevant experience.
Skills / Required:
- Excellent command of English (written and spoken).
- Ability to formulate regulatory medical writing strategies under guided supervision.
- Strong judgment and decision-making in complex and ambiguous situations.
- Strong communication and influencing skills.
- Negotiation and stakeholder-management skills.
- Knowledge of global guidelines and regulations relevant for Regulatory Medical Writing.
Also Good to Have:
- Experience with technical and digital advancements in regulatory medical writing.
- Experience in vendor oversight.
Benefits (explicitly listed):
- Comprehensive Health Insurance (Medical, Dental, Vision, Prescription)
- Retirement Savings (401(k) with employer match)
- Paid Time Off
- Company paid Life and Disability insurance
Application instructions:
- Apply through the internal career site on Twist.