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Therapy Area Head, Global Regulatory Medical Writing Leader
vor 1 Monat
The Opportunity
This is a remote opportunity and candidates can sit anywhere in Germany.
A Director, in Global Regulatory Medical Writing, reports into the Head of Global Regulatory Medical Writing, will primarily work in therapeutic area specific/functional role as a leader and SME representing GRMW in matrixed stakeholder R&D program teams. This role provides a significant level of oversight and SME guidance to internal medical writing team and cross-functional matrixed project teams in the strategic planning, scope determination and development of clinical and regulatory documents used in drug development and product registrations. The Director offers clear guidance, leadership, accountability for the preparation of quality, fit-for-use clinical regulatory documents for various regulatory and reporting purposes in an E2E business model. As per business needs, may write and edit clinical regulatory documents, including submission summaries and other complex documents, as well as resource and budget management.
Key Responsibilities
- Primarily works on the therapeutic area/functional level
- Likely to have direct reports; oversees contingent workers and/or vendors; provides training to others; strategically analyzes needs to manage resources and is accountable for resource allocation for therapeutic specific business needs with support from department head
- Oversees/provides guidance and accountable for all document types prepared by medical writers, review documents internally within medical writing function before stakeholder engagement, may write and edit clinical regulatory documents (all types) as per business needs
- Ensures that documents are fit-for-purpose, contains clear and consistent medical/scientific messaging that are accurate and complete, adheres to applicable regulatory guidelines, ICH guidance, and Teva standards
- Leads/contributes to the preparation/revision of document templates
- Participates in the recruiting/hiring process, development of direct reports including identifying learning/training opportunities, performance assessment and reviews
- Responsible for tracking/providing team metrics and establish key performance indicators
Requirements
Required:
- PhD or PharmD in life sciences (or other related field) is preferred or Master's degree in life sciences (or other related field)
- PhD or Pharm D with a minimum of 8 years of experience Master's degree with minimum of 10 years of experience
Functional Knowledge
Expert in all document types. Oversees/mentors for all document types at therapeutic area or functional level.
Guides/oversees medical writers; considered a proficient manager with regulatory medical writing expertise.
Considered an internal expert in all aspects of regulatory medical writing and clinical drug development.
Influences and potentially leads creation of regulatory medical writing processes and standards. Serves as subject matter expert for the Medical Writing function.
Related Knowledge
Knowledge of global regulations and guidelines for document submissions, and experienced in leading regulatory global submissions
Job-Specific Competencies
- Excellent written and oral communication skills
- Team player, dynamic, engaged, and agile to drive business needs and execute departmental vision at Teva
- Primary accountability is delivering high quality documents that are fit-for-use and within timelines with medical writing colleagues
- Represents MW in program teams providing leadership and guidance as an SME
- Addresses business/program/project level issues; makes independent decisions using past experience and current situation to drive solutions and mitigate risks
- Persuades and inspires team to take action; coaches and mentors' junior medical writers and team as applicable to build MW SME presence, has expert negotiation skills
- Contributes to content preparation for departmental initiatives, participates in process development, and improvement cross-functionally with direction from department head
- Leads development of process, and preparation/revision of SOPs and guidance documents with department head and medical writing LT team
- Forecasts and maintains budget as per business needs and direction from department head
What We Offer
At Teva
- We take care of your health (among other things through a company health management system, a company doctor, physiotherapy, sports activities and a company canteen)
- You have time for your family (through our own company kindergarten and holiday camps for school children, as well as 30 days of vacation)
- You can develop your potential to the fullest (through a comprehensive virtual training program)
- Your achievements are valued accordingly (e.g. through recognition and Senior-Leaders-Programs, as well as various company events)
- We think together with you about your future (e.g. through a company pension scheme)
Function
Research & Development
