Director, Therapy Area Head, Global Regulatory Medical Writing (Usa, Remote)

8 years

Not Disclosed

Parsippany

10 Nov. 21, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./D.Pharm/B.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Who We Are

Teva Pharmaceuticals is a global leader in the pharmaceutical industry. Our employees are at the core of our success, delivering high-quality medicines to 200 million people daily in over 80 countries.

Our Focus Areas:

Developing patient-centric solutions.
Growing our generic and specialty medicines business through investments in research, development, marketing, and innovation.
Upholding integrity and ethical business practices.
Innovating to create value for patients, healthcare partners, and stakeholders.

Join us on our journey to strategic growth:

Make an impact by working on a diverse portfolio of products within our promising pipeline.
Help make healthcare accessible to more patients as part of a global R&D team.
Improve health and enable people to live better, healthier lives.

The Opportunity: Director, Global Regulatory Medical Writing (GRMW)

Position Overview

As a Director in Global Regulatory Medical Writing, you will serve as a leader and subject matter expert (SME) in a therapeutic area, representing GRMW in matrixed R&D teams. You will provide oversight, strategic guidance, and leadership for the preparation of high-quality clinical and regulatory documents.

This role also involves mentoring and managing a team, contributing to departmental initiatives, and ensuring alignment with global regulatory standards and organizational goals.

Key Responsibilities

Leadership and Oversight

Manage direct reports and oversee contingent workers/vendors.
Provide training and guidance to the medical writing team.
Allocate resources to meet therapeutic-specific business needs.

Document Management

Oversee and ensure quality of all clinical regulatory documents prepared by the medical writing team.
Write and edit clinical regulatory documents (e.g., submission summaries, clinical study reports) as needed.
Ensure documents are:
- Fit-for-purpose and aligned with regulatory guidelines.
- Clear, consistent, and scientifically accurate.

Strategic Contributions

Lead the preparation and revision of document templates, SOPs, and guidance documents.
Serve as an SME in program teams, providing leadership and solutions to project-level challenges.
Forecast and maintain budgets for departmental needs.

Team Development

Mentor and coach junior writers, fostering their growth and development as SMEs.
Participate in hiring, training, and performance evaluations of direct reports.
Inspire and motivate the team to achieve business objectives.

Collaboration and Cross-Functional Engagement

Represent GRMW in cross-functional teams to align processes with organizational goals.
Lead the creation and standardization of regulatory medical writing processes.
Track team metrics and establish key performance indicators.

Your Experience and Qualifications

Education:

PhD or PharmD in life sciences (minimum 8 years of experience).
Master’s degree in life sciences (minimum 10 years of experience).

Skills and Expertise:

Extensive experience in all document types for clinical regulatory submissions.
Knowledge of global regulations and expertise in leading global regulatory submissions.
Strong written and oral communication skills.
Leadership and team-building capabilities.

Key Attributes:

Agile, dynamic, and team-oriented.
Proficient in managing cross-functional collaboration.
Expert in decision-making, negotiation, and risk mitigation.

Why Join Teva?

Comprehensive Benefits Package:

Health Insurance: Medical, Dental, Vision, and Prescription coverage from Day 1.
Retirement Savings:
- 401(k) with employer match (up to 6%).
- Annual 3.75% Defined Contribution to the 401(k) plan.
Paid Time Off (PTO):
- Vacation, sick/safe time, caretaker time.
- 13 paid holidays and 3 floating holidays.
Life and Disability Protection: Company-paid insurance.
Additional Benefits: Tuition assistance, Employee Stock Purchase Plan, Parental Leave, Identity Theft Protection, Legal Plans, and more.

Reports To

Head of Global Regulatory Medical Writing

Application Process

Current Teva Employees: Apply through the Internal Career Site on Employee Central for priority consideration.
External Applicants: Submit your CV and cover letter, highlighting relevant skills and experiences.

Equal Employment Opportunity Commitment

Teva Pharmaceuticals is dedicated to fostering a diverse and inclusive workplace.

We provide equal employment opportunities without regard to age, race, gender, religion, disability, or other legally recognized statuses.
Accommodations will be provided during the recruitment process as needed.

Important Notice for Employment Agencies

Teva does not accept unsolicited assistance from agencies for employment opportunities. All CVs/resumes submitted without a valid written search agreement will be deemed the sole property of Teva, and no fees will be paid.

Role Location

This is a remote opportunity and can be based anywhere in the United States.

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Director, Therapy Area Head, Global Regulatory Medical Writing (Usa, Remote)

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