Director, Therapy Area Head, Global Regulatory Medical Writing

Director, Therapy Area Head, Global Regulatory Medical Writing

Date: Sep 20, 2024

Location: Parsippany, United States, New Jersey, 07005

Job Id: 57648

Who we are

Teva is a global pharmaceutical leader. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation.
At Teva, we strive to deliver quality medicines to patients around the world with integrity and ethical business practices. Our culture is about not only what we do, but how we do it. We innovate to create value for patients, our partners in the healthcare system and our stakeholders. We constantly look for original and better ways to excel, creating solutions for current and future unmet needs.

Join us on our journey of pivot to strategic growth:

• To make an impact, innovate, and work on a 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.

The opportunity

This is a remote opportunity and candidate can sit anywhere in the United States.

A Director, in Global Regulatory Medical Writing, reports into Head of Global Regulatory Medical Writing, will primarily work in a 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, and 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.

How you’ll spend your day

• 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, reviews documents internally within the 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, contain clear and consistent medical/scientific messaging that is accurate and complete, and 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 establishing key performance indicators.

Your experience and qualifications

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 a 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 the 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.
• 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 the 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.

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.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.