WRITEMAN Cambridge, England, United Kingdom
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HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission to serve patients drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of.
ASSOCIATE LEGAL COUNSEL
What You Will Do
Let's do this. Let's change the world. In this vital role you will be responsible for legal support of Amgen's Global Development Organization, as well as Global Regulatory Affairs, Patient Safety, Medical Affairs, R&D Quality and Compliance, and other R&D functions.
* 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.
What We Expect Of You
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
* Degree educated and admission to practice Law in 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.
What You Can Expect Of Us
As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
* 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.
LOCATION:
Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.
Apply now
for a career that defies imagination. Objects in your future are closer than they appear. Join us.
careers.amgen.com
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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