Job Description
A Manager in the Global Regulatory Medical Writing and Submission Management organization at Teva provides basic-level oversight and guidance, as well as resource management, for the direct medical-writing support given to Clinical Specialty Development (and other departments as appropriate) in the production of clinical research documentation. This role supports the areas of drug development, product registrations, and product marketing. International and domestic travel required and ample opportunity for professional growth!
Essential Duties & Responsibilities:
Oversees/Mentors for all document types and offers leadership and basic accountability, strategic assistance, and planning support at the product level for clinical regulatory documents
Ensures that these documents include the proper content and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards
Provides mentoring and know-how to medical writers preparing any document type
Aids medical writing (and other) staff on the organization and presentation of information within documents, as well as the design and format of data displays
Performs quality assurance review of documents and participates in meetings at the document team and clinical sub-team levels
Participates in 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 contractor oversight and Identifies, deploys and manages resources
Exhibits competent collaboration, conflict-resolution, and influencing skills
Participates in the recruiting/hiring process, and development of direct reports including identifying learning/training opportunities and executing development plans
Qualifications
MSc/PhD in life sciences (or other related field) with a minimum of 3 years of writing experience in medical writing and or/regulatory writing
Native level English
Previous experience with writing regulatory documents in medical device and Pharma
Experience in preparation of regulated documents in the pharmaceutical/biotech/medical device industry.
Ability to prepare any type of regulatory document(CSR, Protocols, clinical sections for submissions)
Detailed oriented
Previous experience in project management
Ability to work independently
Ability to manage without authority
https://careers.teva/job/Netanya-1111/747407000/?locale=en_US