Director, Therapy Area Head, Global Regulatory Medical Writing
About the position
The Director, Therapy Area Head, Global Regulatory Medical Writing at Teva Pharmaceuticals is a leadership role responsible for overseeing the medical writing team and ensuring the quality and compliance of clinical and regulatory documents. This position involves strategic planning, resource management, and providing expert guidance in the development of documents used in drug development and product registrations. The role is remote and allows for collaboration with cross-functional teams to enhance healthcare accessibility and improve patient outcomes.
Responsibilities
• Lead and oversee the medical writing team, providing guidance and mentorship.
,
• Ensure the preparation of high-quality, fit-for-use clinical regulatory documents.
,
• Manage resources and budget allocation for therapeutic specific business needs.
,
• Participate in the recruiting and hiring process for medical writers.
,
• Track team metrics and establish key performance indicators.
,
• Contribute to the development and revision of document templates and SOPs.
,
• Write and edit clinical regulatory documents as needed.
Requirements
• PhD or PharmD in life sciences (or related field) preferred; Master's degree acceptable.
,
• Minimum of 8 years of experience with a PhD or PharmD; 10 years with a Master's degree.
,
• Expertise in all document types related to regulatory medical writing.
,
• Strong knowledge of global regulations and guidelines for document submissions.
,
• Excellent written and oral communication skills.
Nice-to-haves
• Experience in leading regulatory global submissions.
,
• Proficient in negotiation and influencing skills.
Benefits
• 401(k) with 6% match
,
• Dental insurance
,
• Disability insurance
,
• Employee stock purchase plan
,
• Health insurance
,
• Life insurance
,
• Paid Time Off
,
• 13 paid Holidays
,
• Tuition Assistance
Apply Now
The Director, Therapy Area Head, Global Regulatory Medical Writing at Teva Pharmaceuticals is a leadership role responsible for overseeing the medical writing team and ensuring the quality and compliance of clinical and regulatory documents. This position involves strategic planning, resource management, and providing expert guidance in the development of documents used in drug development and product registrations. The role is remote and allows for collaboration with cross-functional teams to enhance healthcare accessibility and improve patient outcomes.
Responsibilities
• Lead and oversee the medical writing team, providing guidance and mentorship.
,
• Ensure the preparation of high-quality, fit-for-use clinical regulatory documents.
,
• Manage resources and budget allocation for therapeutic specific business needs.
,
• Participate in the recruiting and hiring process for medical writers.
,
• Track team metrics and establish key performance indicators.
,
• Contribute to the development and revision of document templates and SOPs.
,
• Write and edit clinical regulatory documents as needed.
Requirements
• PhD or PharmD in life sciences (or related field) preferred; Master's degree acceptable.
,
• Minimum of 8 years of experience with a PhD or PharmD; 10 years with a Master's degree.
,
• Expertise in all document types related to regulatory medical writing.
,
• Strong knowledge of global regulations and guidelines for document submissions.
,
• Excellent written and oral communication skills.
Nice-to-haves
• Experience in leading regulatory global submissions.
,
• Proficient in negotiation and influencing skills.
Benefits
• 401(k) with 6% match
,
• Dental insurance
,
• Disability insurance
,
• Employee stock purchase plan
,
• Health insurance
,
• Life insurance
,
• Paid Time Off
,
• 13 paid Holidays
,
• Tuition Assistance
Apply Now