Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Senior Regulatory Labelling Associate (Cambridge or Uxbridge)

Company: Amgen
Location: Cambridge or Uxbridge
Reference: D011214
Closing Date: 27 Dec 18
Type: Full Time
Salary (£): Competitive
Benefits: Excellent

Job Summary:

Amgen Regulatory Labelling team are looking for an enthusiastic team player who is detail-oriented and has excellent verbal and written communication skills. Your key role will be to support the EU Labelling managers in executing Labelling tasks.

Requirements:

Senior Regulatory Labelling Associate

Competitive salary & comprehensive benefits package including bonus scheme

Cambridge or Uxbridge

 

If you are looking for your next career step within Regulatory Labelling field and want to be part of our mission – To serve patients – which drives all that we do, apply or get in touch.

 

Our Regulatory Labelling Team:

Labelling Process Management in Europe (LPM-EU) support the European Regional Regulatory Leads, Local Regulatory Representatives, Operations and Artwork in implementing product labelling into the European market. We are a small, friendly team committed to providing timely, high quality and compliant product information.

 

Sr Regulatory Labelling Associate role overview:

The Sr Regulatory Labelling Associate will report to the Director of Labelling Process Management. In this role, you will support all commercial products from a regional (European Union and extended Europe) labelling perspective.

As a Senior Regulatory Labelling Associate, you will provide product support to corporate Global Labelling and Regulatory staff (both regional and local) in implementing and maintaining processes for drug product information and product component labelling. The role is varied and requires high attention to detail and the ability to work on multiple tasks in parallel.

 

Responsibilities:

EU centralised procedure submissions:

  • Initiate linguistic review with vendor
  • At CHMP opinion, provide linguistic review timetable to vendor, EURL and LRRs
  • Monitor Linguistic Review trackers
  • End of member state review deadline follow up with EMA for any missing comments
  • Finalise translations and submit to agency

 

EU artwork projects:

  • Finalise translations for artwork, initiate approval dating, PV and contact details in leaflet, source text provision in LEXA – Amgen’s end to end labelling tracking tool.
  • Approve English master artwork (ensure alignment between approved source and text mapping) for cartons, labels, leaflets etc.

 

LEXA tasks:

  • Triage requests for label change
  • Complete LEXA-IMR linkage
  • Initiate and complete detailed artwork project tasks
  • Link source text to Artwork Projects
  • Complete “Approve Internally” action for Submission Packs
  • Initiate Artwork Projects in LEXA for launches as requested by ROLs
  • Complete post health authority approval tasks, initiate global labelling notifications (GLN) at procedure approval, distribute notification and complete “GLN Sent Date”
  • Complete public domain tasks

 

Translation management:

  • Initiate translations using the translation management tool
  • Inform LRRs of translation timelines
  • Interactions with vendors and Local Regulatory Representatives (LRR):

 

Other responsibilities will include:

  • Support local regulatory by providing guidance in maintaining data in LEXA and documents in the document management system (EPIC), including clarification of processes
  • As requested, support the development and maintenance of business process documentation and guidance; SOPs, manuals, forms, and eManual
  • Support initiatives which involve labelling
  • Qualifications and required experience:
  • Previous experience within pharmaceutical industry within, Labelling, Regulatory, Quality Management / Quality Engineering is required
  • Proven experience using document management tools
  • Proven experience and skills needed:
  • Strong oral and written communication skills
  • Strong interpersonal, collaborative, problem solving and conflict resolution skills
  • Ability to work well with others in demanding situations with a positive attitude
  • Ability to work in a fast-paced environment while retaining a high attention to detail
  • Excellent organizational and project management skills
  • Strong computer skills, including word processing, database document repository and project management software


 

About our company:

Amgen is one of the world’s largest independent biotechnology companies, with global revenue of $23 billion and nearly 20,000 employees globally. For more than 35 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.

 

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

 

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

 

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

 

Apply for this job: Senior Regulatory Labelling Associate (Cambridge or Uxbridge)

Contact Information:

Address:  Amgen (Uxbridge)
1 Uxbridge Business Park
Sanderson Road
Uxbridge
UB8 1DH
England
Tel:  + 44 1895 525000
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.