French Medical Review Lead
Location: This position will be initially based out of Cork, Ireland with travel across Europe as needed
About the company:
With offices across the world, my client is partner to most of the worlds Top 25 pharma companies helping transform their commercial and medical operations.
As life sciences companies embrace digital and omni-channel marketing for more personalized customer engagement, my client helps enable this shift by integrating commercial content development with deep data, analytics, and campaign expertise.
Across brands and geographies, we help some of the worlds largest pharma companies drive consolidation and excellence in omni-channel customer experiences by integrating data operations, and advanced analytics into the design and personalization of customer campaigns and creation of digital content.
This is enabled by bringing together deep analytics expertise and contemporary AI and Big Data technology to establish Global Centres of Excellence for Marketing Operations.
Further, our co-commercialization solutions integrate all our omni-channel expertise and our proprietary technologies on a turnkey basis to help life sciences companies drive auditable revenue growth for their brands across the product lifecycle and a wide range of business needs.
Across the industry, medical organizations are increasingly looking to drive efficiency and productivity in all traditional work streams that are human/capital/ time intensive, while maintaining high compliance of regulatory requirements. My client has an enviable track record of providing full-spectrum enterprise business solutions for clinical, regulatory, safety and medical affairs, and has always been known for its strong domain expertise. It is now delivering differentiated outcomes (faster clinical trials, reduced time-to-agency, intelligent real-world evidence, enhanced productivities & efficiencies, higher accuracy and compliance) by contextualizing modern AI, ML and NLP technologies for the life sciences and thereby disrupting the status quo.
In light of this, the position for Medical Review Lead is crucial.
S/He partners with the MLR team at our key clients worldwide. The role will require you to work closely with end-customers and business unit leadership in the US, EU, and India. To this end, we are looking for people with an experience and expertise and the ability to work with cross-functional teams to define and execute on priorities, and to serve as a trusted partner to senior leaders across the client organization.
The Job entails the following but is not limited to:
- Work on different projects with pharmaceutical clients as medical reviewer/expert.
- Serve as the medical reviewer for the clients Review Committee to ensure timely review of materials intended for internal or external audiences
- Review promotional and scientific materials to ensure presentation of promotional claims reflect strengths and weaknesses of supporting data, medical accuracy, clinical relevance of study methodology, appropriateness of content for the intended audience, and accurate interpretation/use of data
- Review materials against approved labelling to verify accuracy and appropriateness of reference and data on file citations
- Provide guidance on the development and use of medical and scientific materials including but not limited to medical response letters, presentations, publications and scientific exchange resources
- Provide medical guidance on sales training and promotional materials advertised through broadcast, internet or print, including but not limited to presentations, sales aids, and websites
- Maintain strong knowledge of and monitor changes to regulations and guidance surrounding prescription drug and medical device advertising and promotion
- Monitor new literature to ensure representation of current citations related to clinical data, medical concepts and disease state facts
- Conduct reviews utilizing a validated, electronic platform and adhere to clients Medical Affairs policies, standard operating procedures, work instructions and training programs as needed
- Collaborate with cross-functional teams and provide scientific cross-functional support as needed
- Provide medical expertise, advice, guidance, training, and support to the team as well as client organization.
- Assist internal teams and client organization in development of medical strategy, guidance and expertise on new marketing concepts and promotional tactics for assigned product(s).
- Basic Qualification:
- Education: Advanced degree, PharmD, or MD in health care field required
- Experience: Minimum of 8 years relevant experience
- Desired Skills and Experience
- 8 years of relevant pharmaceutical industry experience as a medical reviewer in leading teams in advertising and promotion
- Experience in Pharma industry and MLR reviews, as medical reviewer in MLR committee
- Knowledge of ABPI and EFPIA requirements related to the medical review function
- Experience in Pharma Medical Affairs and Advisory Board highly desirable
- Established expertise in drug information
- Positive attitude and project management ability
- Excellent interpersonal, oral and written communication skills
- Strong administrative management skills and ability to work effectively with others
- Italian and English at a fluent level