Teva Director Therapy Area Head Global Regulatory Medical Writing 

United States, New Jersey 

622307465

Join us on our journey of pivot to strategic growth:

• To make an impact, innovate, and work on diverse portfolio of products within a promising pipeline centered around our core therapeutic areas
• To help make healthcare accessible to more patients, as part of a highly global diverse matrixed R&D team,
• To improve health and enable people to live better, healthier lives.
  

• 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

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
  

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

The annual starting salary for this position is between $177,000- $233,000 annually. Factors which may affect starting pay within this range may include geography/market, skills, education, experience and other qualifications of the successful candidate.
This position may also be eligible for bonus, sales target(s), and/or long-term incentive compensation awards. Level of the role will be commensurate to years of experience and performance criteria.