Informacje o stanowisku
For our Client, one of the largest Pharmaceutical companies worldwide, we are looking for Global Labeling Senior Associate , who will ensure quality of primary and derived labeling documents and ensure support for the documents.
If you have relavant experience and would like to participate in the global labeling strategy, apply for this role.
What we expect
- educational background (univeristy degree in Life Sciences, Pharmacy etc.)
- professional experience in pharmaceutical/ medical industry
- experience in Regulatory Affairs with focuse on product labeling/labeling regulations
- understanding of drug development, including the therapeutic area(s) and individual product knowledge
- expertise in writing pharmaceutical labeling
- strong verbal and written communication skills
Employment agency entry number 47
this job offer is intended for people over 18 years of age
What we offer
- Beneficial leave policies
- Medical Care program & Life Insurance
- Pension plan
- Reimbursement of Exercises/WellBeing Programs and Cultural Activitie
- Company car
Your tasks
- Assists in the preparation and revision of text for labeling documents
- Conducts reviews, comparisons, and analyses of competitor labeling.
- Performs administrative tasks, as required
- Prepares/updates chronologies for labeling documents.
- Develops and communicates labeling summaries for annual reports.
- Reviews labeling forms and ensures completeness. Processes deviation requests with supervision and completes deviation tracking spreadsheet in a timely and accurate manner.
- Helps with projects of low to medium complexity in compliance with global labeling procedures.
- With close supervision, collaborate with applicable functions to develop, revise, review, and gain agreement of primary and derived labeling documents for content having low to medium complexity.
- Proactively remain current with new guidelines and processes.
- Learn relevant organizational functions, business units, and the contribution of each to the overall business success.
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