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