Post by mark on Sept 14, 2015 14:20:47 GMT
Regulatory Affair assistant in Pharmaceuticals
15th September 2015
About us
During the last half-century, we have brought together a number of innovative pharmaceutical companies with one overarching goal: to address and solve some of the most important unmet medical needs of our time. Today, we are united under a common name — the Janssen Pharmaceutical Companies of Johnson & Johnson.
Together, we share a vision of providing innovative solutions that bring value to people, healthcare professionals and health systems around the world.
Summary
Under close supervision, performs limited or routine duties in the preparation, review and submission of pre- and post-approval submissions to the Food and Drug Administration, using governmental guidelines and regulations.
Qualifications
MSc specialized in regulatory affairs or equivalent needed
No experience required
Knowledge
-Current Food and Drug Administration (FDA) regulations and guidelines.
-Logistics and work of the pharmaceutical industry.
-Personal computer hardware and software applications.
-Business English usage, spelling, grammar and punctuation.
Skills
-Responding to routine inquiries from management, employees and regulatory agencies.
-Communicating clearly and concisely, both orally and in writing.
-Managing multiple projects, duties and assignments.
-Applying Federal, state and local policies, procedures, laws and regulations.
-Ensuring compliance with all Company policies and procedures, including safety rules and regulations.
Salary: to be discuss, can be reevaluated after the first 6 months contract
Location: High Wycombe, Buckinghamshire , UK
Full time position with a 6 months contract that can be extended to an unlimited-term contract
Contact information: send your CV and cover letter to j.m.ido[at]jnj.com and m.y.best[at]janssen-cilag.com
