Director (m/f/d) Therapy Area Head, Global Regulatory Medical Writing

at  Teva Pharmaceuticals

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Director (m/f/d) Therapy Area Head, Global Regulatory Medical Writing
Date: Sep 26, 2024
Location:Ulm, Germany, Other/Not Applicable, 89079
Company: Teva Pharmaceuticals
Job Id: 58272

WHO WE ARE

We want to improve the life of our patients. That is our daily mission. We are proud of our 2,900 employees who provide millions of people with essential medicines every day. Health needs a healthy environment - we are committed to this and, as an environmental pioneer in the German pharmaceutical industry, we set our German sites carbon-neutral in 2021.
And that’s not all: we are represented We want to improve the life of our patients. in over 60 countries worldwide, the market leader in generics and the home of Germany’s well-known pharmaceutical brand ratiopharm. As a full-service provider, we offer a wide range of approximately 3,500 products. These includes innovative medicines, generics, biosimilars and over-the-counter medicines. In our global network, we are constantly developing new, innovative therapies to further improve healthcare for all people. Several teams located at the German site are part of Global and European departments and thus contribute to Teva’s success around the globe.
In a nutshell: We are Teva - and we are very proud of it!
If you feel like us and if you are someone who enjoys exploring unknown paths - then we would like to get to know you. Are you also enthusiastic about global markets and pioneering technologies? And would you like to develop the future of healthcare at a leading provider of medicines? Fantastic! Then become part of our team!
Curious about the German site? Fantastic, then take a look: https://www.youtube.com/embed/73i_f4kpfVU?rel=0&showinfo

YOUR EXPERIENCE AND QUALIFICATIONS

Required:

• PhD or PharmD in life sciences (or other related field) is preferred or Master’s degree in life sciences (or other related field)
• PhD or Pharm D with a minimum of 8 years of experience Master’s degree with minimum of 10 years of experience

Functional Knowledge:

• Expert in all document types. Oversees/mentors for all document types at therapeutic area or functional level.
• Guides/oversees medical writers; considered a proficient manager with regulatory medical writing expertise.
• Considered an internal expert in all aspects of regulatory medical writing and clinical drug development.
• Influences and potentially leads creation of regulatory medical writing processes and standards. Serves as subject matter expert for the Medical Writing function.

Related Knowledge:
Knowledge of global regulations and guidelines for document submissions, and experienced in leading regulatory global submissions

Job-Specific Competencies:

• Excellent written and oral communication skills
• Team player, dynamic, engaged, and agile to drive business needs and execute departmental vision at Teva
• Primary accountability is delivering high quality documents that are fit-for-use and within timelines with medical writing colleagues
• Represents MW in program teams providing leadership and guidance as an SME
• Addresses business/program/project level issues; makes independent decisions using past experience and current situation to drive solutions and mitigate risks
• Persuades and inspires team to take action; coaches and mentors’ junior medical writers and team as applicable to build MW SME presence, has expert negotiation skills
• Contributes to content preparation for departmental initiatives, participates in process development, and improvement cross-functionally with direction from department head
• Leads development of process, and preparation/revision of SOPs and guidance documents with department head and medical writing LT team
• Forecasts and maintains budget as per business needs and direction from department head

Please refer the Job description for details