Regulatory Labelling Project Manager job in Maidenhead, England

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Labelling & Artwork

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

Proclinical has partnered with a global pharmaceutical company in search for an EU Labelling Project Manager to be responsible for End to End labelling. You will be expected to work cross-functionally with a number of functions to ensure timelines and accuracy are both met.

Job Responsibilities

Creates/updates the EU PL in line with the draft SmPC, EU labelling requirements and language required for patient centric texts. Reviews/QCs final draft PI for submission.
Works closely with the SGL US team to ensure alignment with the agreed global labelling strategy.
QC SmPC/PL and labelling text updates as required.
For assigned marketed products, reviews the CCDS revisions and redlines the EU SmPC accordingly or for non-CCDS driven changes drafts the updates.
Participates in and contributes to Labelling Sub team (LST) meetings during labelling negotiations for assigned products.
Works to ensure quality documents are internally maintained and submitted to EMA.
Determines the need for artwork updates for Assigned products, leads mock-up discussions and review/approval for assigned products.
Leads readability testing strategy for assigned products.
Leads linguistic review translation co-ordination and co-ordinates with the vendor and affiliates.
Supports product launches where required for EU labelling function.
Updates, maintains, sends for approval website labeling content as needed.

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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