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Medical Compliance Reviewer - Nom Sig

Employer
Indegene
Location
UK
Salary
Competitive
Closing date
7 Jul 2022

View more

Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
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Indegene is on a mission to empower every healthcare enterprise in its transformation journey. We are uniquely positioned to solve the challenges of the healthcare industry through our combination of deep medical knowledge and verticalized technology and help make healthcare affordable and accessible to every person on the planet.

We are innovators at heart and real innovation for us means constantly obsessing over what will drive success for our customers in the future. No wonder 18 of the top 20 global biopharma organizations lean on us for an agile and enduring partnership. With more than 3000 brilliant employees spread across the US, Europe, China, and India, we have delivered over 100 strategic engagements and fully commercialized over a $2 billion portfolio.

We have brought together a group of incredibly passionate and brilliant people and entrusted them to solve some of healthcare's most challenging problems, which has led to our culture being centered on passion, innovation, and collaboration. We're passionate about healthcare; we believe that technology and innovation will carve an indomitable path in transforming healthcare for the better, and to achieve this, we collaborate with the best minds in the medical and technological domains from 50 different countries.

Medical Compliance Reviewer

The medical reviewer will serve as a medical representative and certifier of the UK pharma's Medical, Legal, Regulatory (MLR) review team.

Day to Day You'll Be Responsible For:

· Serve as the medical delegate on UK Medical, Legal, and Regulatory (MLR) review committee, which is responsible for review, approval, and certification (where applicable) of promotional and medical materials containing information on pharmaceutical company's marketed products and compounds in development, as well as the corresponding disease states developed for UK markets.

· Review materials and ensure data included are accurate, within context, and presented in a fair/scientifically-balanced manner. Verify substantiation of all claims and comparisons. Determine acceptability of references, advise on whether claims are consistent with appropriate approved label, and ensure that the piece is relevant and of utility for the target audience.

· Advise on materials and events designed and produced by UK/global marketing and medical teams to ensure compliance with company policies and UK standards for ethical promotion and scientific interactions.

· Support marketing and medical colleagues through guidance and provision of information on company products, brand messages and claims that are in compliance with regulatory requirements and applicable external codes of practice, including the ABPI (Association of the British Pharmaceutical Industry), EFPIA (European Federation Pharmaceutical Industries and Associations) and IFPMA (International Federation of Pharmaceutical Manufacturers) codes.

· Ensure standards for promotional claims and non-promotional product information sharing, ensuring promotions and communications adhere to regulations and support appropriate use of products.

· Work collaboratively and develop a good working relationship with the Marketing and Multi-channel Consultants, Medical Affairs Leads, and Medical Director to ensure alignment to company's marketing and medical strategy. This includes escalating materials accordingly when guidance is required.

· Work collaboratively with cross-functional teams supporting in creation and review of above-country and affiliate/country materials and projects

About You:

· Strong scientific acumen and ability to grasp complex therapeutic areas, including immunology, neurology and oncology.

· Sound knowledge of international and EU and UK medical compliance regulations, codes of practice and their practical application.

· Good multitasking, project management, and organizational skills.

· Solution oriented, positive attitude and excellent interpersonal skills; as well as oral and written communication skills.

· Experience working as part of a multi-national team

· Ability to work cross-functionally with marketing, legal, regulatory, medical affairs

Must Have:

· UK-register pharmacist or physician

· Experience in pharmaceutical industry within medical affairs; experience working on a cross-functional Medical, Legal, Regulatory (MLR) review committee.

Nice to Have:

· Previous experience as UK nominated signatory (with MHRA) for a pharmaceutical company.
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