Associate Director, Clinical Development Medical Writing (Remote)
Teva Pharmaceutical Industries
Who we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The Associate Director, Clinical Development Medical Writing, provides a significant level of oversight and expert guidance, as well as resource management for the direct medical-writing support given to Clinical Specialty Development (and other departments as appropriate) in the production of clinical research documentation in support of drug development, product registrations, and product marketing.
The Associate Director offers clear leadership and extensive accountability, strategic vision, and planning direction at the therapeutic-area level (may multiple therapeutic areas) for clinical regulatory documents, and ensures that these documents include the proper content and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards. The Associate Director provides mentoring and proficiency to medical writers preparing any document type.
Travel Requirements: International and domestic
Location: US-Based Remote (US Eastern time zone preferred)
RELOCATION ASSISTANCE IS NOT AVAILABLE
WORK VISA SPONSORSHIP IS AVAILABLE
How you’ll spend your day
- Primarily work on the multiple product/program level
- Manage direct reports; contingent workers and/or vendors and provides training to others
- Strategically analyze needs to manage resources. Manages/mentors for all document types
- Write and edit clinical regulatory documents (all types)
- Ensure that documents include the proper context and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messaging, are accurate and complete, and adheres to applicable regulatory guidelines and departmental and editorial standards
- Lead/recommend the preparation/revision of document templates
- Formulate strategy under guided supervision; demonstrates "big picture" perspective leveraging experience to recommend strategies
- Tackle difficult problems; makes decisions and troubleshoots in ambiguous situations
- Drive communication toward common understanding and actionable results; proficient in negotiation skills; and conceptualizes and leads initiatives within function
- Lead development of process, and preparation/revision of SOPs and guidance documents
- Manage and delivers assignments with quality and within timelines
- Provide input for budget planning
- Participate in the recruiting/hiring process, and development of direct reports including identifying learning/training opportunities and executing development plans.
Your experience and qualifications
- Master's degree in life sciences or related scientific discipline with at least 7 years of pharmaceutical industry regulatory writing experience. (CSRs, protocols and IBs.)
Enjoy a more rewarding choice
We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.
Therapy Area Head, Medical Writing
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