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Director (M/F/D) Therapy Area Head, Global Regulatory Medical Writing

10+ years
Not Disclosed
10 Nov. 22, 2024
Job Description
Job Type: Remote Education: PhD/Life Science/Pharm.D 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

About Us

At Teva Pharmaceuticals, our mission is to improve patients' lives. With a workforce of 2,900 employees in Germany, we provide essential medicines to millions of people every day. Recognizing the critical connection between health and the environment, we achieved carbon neutrality at our German sites in 2021, becoming a pioneer in sustainability within the German pharmaceutical industry.

Globally, we operate in over 60 countries and are the market leader in generics, home to Germany’s renowned pharmaceutical brand, ratiopharm. As a full-service provider, we offer a diverse portfolio of approximately 3,500 products, ranging from generics and biosimilars to innovative and over-the-counter medicines. Through our global network, we are continually developing new therapies to enhance healthcare for people worldwide.

We are proud of our impact and strive to innovate, explore new paths, and shape the future of healthcare. Join us and be part of this journey!


Job Opportunity: Director, Global Regulatory Medical Writing

Location: Remote – Candidate can be based anywhere in Germany.
Reporting To: Senior Director, Head of Global Regulatory Medical Writing.

As a Director in Global Regulatory Medical Writing (GRMW), you will lead strategic planning, document preparation, and team oversight for therapeutic area-specific or functional roles. Representing GRMW within cross-functional R&D teams, you will guide internal medical writing teams, ensuring clinical and regulatory documents meet high-quality standards and regulatory guidelines. This role includes leadership responsibilities, team development, and budget/resource management.


Key Responsibilities

Leadership and Team Oversight

  • Provide strategic guidance for therapeutic area-specific projects and oversee direct reports, contingent workers, and vendors.
  • Lead resource allocation, team training, and professional development, including performance reviews and hiring processes.
  • Represent the Medical Writing (MW) function in program teams, offering expertise as a Subject Matter Expert (SME).

Document Preparation and Review

  • Oversee and review clinical and regulatory documents, ensuring they are fit-for-purpose, compliant with global guidelines, and aligned with Teva’s standards.
  • Prepare/revise document templates and contribute to writing/editing complex regulatory documents as needed.
  • Ensure clear, consistent scientific messaging and accuracy across all documents.

Process Development and Metrics

  • Develop departmental processes, SOPs, and guidance documents in collaboration with leadership teams.
  • Track and report team metrics, establish Key Performance Indicators (KPIs), and forecast budgets as per business needs.

Cross-Functional Collaboration

  • Provide leadership in global submission processes, aligning with regulatory and clinical development teams.
  • Actively contribute to departmental initiatives and process improvements.

Qualifications

Required:

  • PhD or PharmD in Life Sciences (preferred) or Master’s degree in a related field.
  • 8+ years (PhD/PharmD) or 10+ years (Master’s degree) of experience in regulatory medical writing.

Expertise:

  • Proficient in preparing all clinical regulatory document types.
  • Advanced knowledge of global regulations and guidelines for document submissions.
  • Demonstrated ability to lead regulatory global submissions and mentor medical writers.

Competencies:

  • Excellent written and verbal communication skills.
  • Strong leadership, decision-making, and negotiation abilities.
  • Experience managing resources, budgets, and cross-functional teams.

What We Offer

At Teva, we care about your health, work-life balance, and career development:

  • Health Benefits: Company health management system, on-site doctor, physiotherapy, sports activities, and a company canteen.
  • Work-Life Balance: 30 days of vacation, a company kindergarten, and holiday camps for children.
  • Professional Growth: Comprehensive virtual training programs, leadership recognition initiatives, and career development opportunities.
  • Future Planning: Company pension scheme and various company events to celebrate achievements.

Application Process

Current Teva Employees:
Apply via the Internal Career Site on "Employee Central" for priority consideration. If you encounter access issues, contact HR/IT support.


Equal Employment Opportunity

Teva Pharmaceuticals is an Equal Opportunity Employer, providing employment without discrimination based on age, race, religion, gender, disability, or other legally recognized statuses. We are committed to a diverse and inclusive workplace.

If you require accommodations during the recruitment process, please inform us. All information will remain confidential and used solely for creating an accessible candidate experience.


Join Teva Pharmaceuticals and help us make a meaningful impact on healthcare worldwide!