SUMMARY DESCRIPTIONState the overall function or purpose of the job.
This position will be responsible as the regulatory lead for review of promotional materials for our client's commercial portfolio in the EU region. This will involve review of materials against the approved product labelling, and the relevant guidance which for this role are particularly the EFPIA Code of Practice and the ABPI Code of Practice. This position will be required to interact frequently with the cross-functional team responsible for the core promotional materials developed for use in the region eg Marketing, Legal/Compliance, Medical Affairs. This role can be based in the London office or remotely.
RESPONSIBILITIESList the major responsibilities of the job.
- Provide regulatory promotional review for the portfolio of commercial products in the region. These are currently 5 products, with an additional two product approvals/launches expected in the next 12 months.
- The role involves review of the core promotional materials (detail aid, leave piece etc) for each product. These are prepared in English and then distributed to the local markets for use following internal review by the reviewing functions (Marketing, Legal/Compliance, Regulatory, Medical Affairs) in line with the relevant SOP.
- The Regulatory Promotional Material reviewer is responsible for ensuring proposed promotional materials are consistent with approved product labelling, and consistent with the requirements of the EFPIA Code of Practice and the ABPI Code of Practice.
- Amendments made to these core materials by local markets in line with local requirements, are back translated to English for further review by the cross-functional reviewers to ensure they are still consistent with approved product labelling and the EFPIA/ABPI Codes of Practice.
- The Regulatory Promotional Material reviewer is also responsible for review and updating of Abbreviated Prescribing Information (API's)
SCOPEQuantify the scope or impact of the job in terms of revenue, expenses, capital investment, headcount, etc.
This position represents a contract position of 23 months duration.
EDUCATIONState both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc.
BSc degree in life sciences
EXPERIENCEState both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job.
- Highly experienced in regulatory review of Promotional Materials, in particular with review against the provisions of the EFPIA Code of Practice and the ABPI Code of Practice.
- Experience with/awareness of regulatory requirements and enforcement for promotional materials in the major EU markets (DE, FR, ES, IT) would be valuable, but not essential.
- Skilled at working independently and as part of a team, this role will work closely with the cross functional team responsible for review and sign off of promotional materials for the region (including designated commercial/marketing, legal/compliance, and Medical Affairs personnel)
- This role calls for a mature and professional approach to review of promotional materials, the successful candidate will be able to defend their position with cross-functional colleagues, but also be able to suggest effective and compliant alternative approaches and solutions.
- Outstanding interpersonal and communication (written and verbal) skills