
Associate Legal Counsel
- Cambridgeshire
- Permanent
- Full-time
- Working directly with clients, provide strategic and practical legal counsel on a wide variety of drug and device development legal and regulatory issues.
- As a strategic partner, work to identify and advise on regulatory issues with important legal implications both independently and as part of a larger team.
- Collaborate with internal clients and Law Department colleagues in different countries and across departments.
- Degree educated and admission to practice Law n European jurisdiction.
- Previous experience as an attorney in a large law firm, biopharmaceutical company, or in a major government agency practicing law related to biotechnology, pharmaceutical, device and/or healthcare.
- Experience working with the regulatory authorities and the laws and regulations relating to the discovery, development, approval, sales & marketing of biotechnology/pharmaceutical/device products, including:
- Review of R&D and Operations related policy matters: consult on policy matters, review draft policies, advise on options, (e.g. Pediatric Investigational Plans, orphan drug designation issues).
- Support Global and EU product team strategy and acute legal questions.
- Legal advice in support of clinical trial execution.
- Pharmacovigilance and Safety: Legal advice in support of GPS Risk Management Plans, Inspection legal support.
- Experience with contracts, and/or products liability.
- Excellent interpersonal skills needed to work in cross functional, cross regional/international teams.
- Ability to handle, prioritize and follow through on diverse issues on a timely basis.
- Strong research and writing skills.
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits