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