Regulatory Promotional Material Reviewer
- Employer
- i-Pharm Consulting
- Location
- London, England
- Salary
- Negotiable
- Start date
- 13 Jul 2021
- Closing date
- 27 Jul 2021
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Management
Job Details
State 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.
RESPONSIBILITIES
List 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)
SCOPE
Quantify 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.
EDUCATION
State 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
EXPERIENCE
State 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
Company
i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.
We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.
Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world.
With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.
For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them.
As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.
We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.
- Website
- http://www.i-pharmconsulting.com/
- Telephone
- +44 (0) 20 3189 2299
- Location
-
52 Bedford Row
London
England
WC1R 4LR
United Kingdom
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