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

8 years
Not Disclosed
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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