Job Detail

Business Purpose

Teva Pharmaceuticals International GmbH is looking for a Senior Manager Medical Writing, in Global Regulatory Medical Writing, providing high-level medical writing support to Clinical Specialty Development (and other departments as appropriate) in the production of clinical research documentation, as well as in support of drug development, product registrations, and product marketing. The Senior Manager offers leadership and fundamental accountability, strategic supervision, and planning assistance at the product and program levels for clinical regulatory documents.

Company Info

Teva Pharmaceuticals International GmbH (“TPIG”) is a subsidiary of Teva Europe based in Switzerland. The company trades mainly Global Specialty medicines & Branded Generics Products with many markets in EU and the US.

The company is also hosting the trading hub for our Latin American markets. The company is engaged in Research and Development through its R&D hub based in Basel, it is also engaged in manufacturing and sales activities which are coordinated out from its headquarter in Jona.

Main Responsibilities

• Oversees and mentors all document types


• Ensures that these documents include the proper content and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messages, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards


• Provides mentoring and capability to medical writers preparing any document type


• Assists medical writing (and other) staff on the organization and presentation of information within documents, as well as the design and format of data displays


• Provides leadership/strategy at the product/program level


• Participates significantly in meetings at the product/program level


• Leads/Recommends the preparation/revision of document templates, development of process, and preparation/revision of SOPs and guidance documents


• Participates in Clinical Research Organization (CRO) alliance and other outsourcing activities


• Provides oversight for contractors


• Identifies, deploys and manages resources


• Performs quality assurance review of documents


• Exhibits proficient collaboration, conflict-resolution, and influencing skills


• Participates in the recruiting/hiring process, and development of staff


• Contributes to managing the budget

Qualifications

• Preferred: PhD in life sciences (or other related field) with a minimum of 5 years of experience related to medical writing or Masters in life sciences (or other related field) with a minimum of 9 years of experience


• Excellent English, both written and spoken


• High-level writing and editing skills and competence in the use of relevant software applications, and using templates, and other electronic formats


• Proper knowledge of regulatory requirements pertaining to drug development and understanding of the Company’s products and standard operating procedures (SOPs)


• Ability to organize and present information and to communicate regulatory medical writing processes and technical and editorial standards


• Excellent organizational/planning and problem-solving skills at the product and program level


• Works successfully with a low level of direct supervision

Function

Research & Development

Sub Function

Clinical Development

Reports To

Dir, Global Regulatory Medical Writing

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.