Sr Director, Global Regulatory Medical Writing & Data Transparency at Tevapharm

Sr Director, Global Regulatory Medical Writing & Data Transparency

Date: Oct 31, 2024

Location: Parsippany, United States, New Jersey, 07054

Job Id: 59073

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day.

The opportunity

The Senior Director in Global Regulatory Medical Writing & Data Transparency provides leadership, direction, and competence to a team of medical writers/managers and electronic document specialists within Clinical Specialty Development for the production of high-quality clinical research documentation, which adheres to departmental standards and regulatory guidelines in support of drug development, product registrations, and product marketing to meet the company’s global strategic, scientific, regulatory, and commercial goals.

The Senior Director will also:

• Offer clear leadership and extensive accountability, strategic vision, and planning direction at the global function level for clinical regulatory documents.
• Serve as a liaison among internal/global functional groups to ensure optimal use of resources in making medical writing support available for all projects.
• Provide mentoring and proficiency to manager-level direct reports.

Location: This is a hybrid opportunity that can be based out of our Parsippany, NJ or West Chester, PA offices.

Your experience and qualifications

• PhD in life sciences (or other related field) with a minimum of 10 years of experience related to medical writing OR Masters in life sciences (or other related field) with a minimum of 15 years of experience.
• Expert/Mentor at global function level to management-level staff.
• Highly skilled at setting regulatory medical writing processes/policies and technical and editorial standards.
• Considered an internal expert in all aspects of regulatory medical writing, T&D, and clinical drug development.
• Knowledge of global regulations and guidelines for T&D and document submissions.

Enjoy a more rewarding choice

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.

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.