Teva Director Therapy Area Head Global Regulatory Medical Writing 

United States, New Jersey 

194182250

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.
  

In this role you will offer 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, you may write and edit clinical regulatory documents, including submission summaries and other complex documents.

• Manage a team of direct reports; oversee contingent workers and/or vendors; provide training to others; strategically analyze needs to manage resources and take accountability for resource allocation for therapeutic specific business needs with support from the department head
• Oversee/provide 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
• Ensure that documents are fit-for-purpose, contain clear and consistent medical/scientific messaging that are accurate and complete, adhere to applicable regulatory guidelines, ICH guidance, and Teva standards
• Lead/contribute to the preparation/revision of document templates
• Participate 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

• PhD or PharmD in life sciences (or other related field) with a minimum of 8 years of experience; Master’s degree in life sciences (or other related field) with minimum of 10 years of experience
• 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.
• Knowledge of global regulations and guidelines for document submissions, and experienced in leading regulatory global submissions
• 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
  

We offer a competitive benefits package, including:
• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, 13 paid Holidays and 3 paid floating holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

Head of Global Regulatory Medical Writing

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