Manager, Medical Writing (Remote, East Coast, USA)

Tevapharm; Pennsylvania; Remote; USD 111,000 - 146,000; Full time

Job summary

Join a forward-thinking company as a Manager in Global Regulatory Medical Writing, where your expertise will help shape the future of healthcare. In this pivotal role, you will be responsible for crafting high-quality clinical regulatory documents essential for drug development and product registrations. Collaborate with a diverse team dedicated to making healthcare more accessible and affordable for millions. This position offers the opportunity to lead and mentor others while ensuring compliance with regulatory standards. If you are passionate about impactful writing and want to contribute to innovative healthcare solutions, this is the perfect opportunity for you.

Benefits

Comprehensive Health Insurance

401(k) with Employer Match

Paid Time Off

Life and Disability Insurance

Employee Assistance Program

Tuition Assistance

Flexible Spending Accounts

Paid Parental Leave

Virtual Physical Therapy

Identity Theft Protection

Qualifications

• PhD or PharmD required with relevant experience in regulatory writing.
• Strong knowledge of drug development regulations and guidelines.

Responsibilities

• Write and edit high-quality clinical regulatory documents.
• Provide guidance and oversight for clinical research documentation.

Skills

Clinical Regulatory Writing

Document Editing

Microsoft Word

Regulatory Guidelines Knowledge

Communication Skills

Problem Solving

Education

PhD in Life Sciences

PharmD in Life Sciences

Master's Degree in Life Sciences

Tools

Document Preparation Software

Electronic Formats

Job description

Manager, Medical Writing (Remote, East Coast, USA)

Location: West Chester, United States, Pennsylvania, 19380

Job Id: 59604

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.

The opportunity

As a Manager in Global Regulatory Medical Writing, you will write and edit high-quality clinical regulatory documents, including submission summaries and other complex materials critical for drug development and product registrations. You will also provide guidance, basic oversight, and resource management to ensure the seamless production of clinical research documentation that supports our mission to deliver innovative healthcare solutions.

How you’ll spend your day

• Write and edit clinical regulatory documents, including submission summaries and other complex documents.
• Ensure that documents include the proper content and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards.
• Offer leadership and basic accountability, provide strategic assistance, and planning support for clinical regulatory documents.
• Manage contingent workers and/or vendors.
• Provide training to others as needed.

Your experience and qualifications

• PhD or PharmD in Life Sciences (or a related field), or a Master’s degree in Life Sciences (or a related field).
• PhD or PharmD with a minimum of 2 years of experience, or a Master’s degree with at least 4 years of experience.
• Preferred experience: 2-4 years in regulatory medical writing.
• Proficiency in Microsoft (MS) Word and advanced use of software, templates, and electronic formats for document preparation.
• Demonstrated expertise in writing and editing clinical regulatory documents, including submission summaries and other complex materials.
• Strong knowledge of government regulations related to drug development, global submission guidelines, therapeutic areas, statistical concepts, and industry standards.
• Proven ability to contribute to strategy development and tackle complex problems, providing actionable solutions.
• Skilled in facilitating effective communication to drive alignment and deliver results.
• Knowledge of global regulations and guidelines for document submissions.
• Experience in process development, improvement initiatives, and budget planning.
• Ability to write, edit, and oversee the creation of high-quality clinical regulatory documents.
• Contribute to the development of strategies under moderate supervision.
• Ensure timely delivery of assignments with a focus on quality.
• Influence and enhance communication for clear, actionable outcomes.
• Exceptional English proficiency, both written and spoken.

Compensation

The annual starting salary for this position is between $111,000 - 146,000. 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. Level of the role will be commensurate to years of experience and performance criteria.

RELOCATION ASSISTANCE AND WORK VISA SPONSORSHIP IS NOT AVAILABLE

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.