Title:  Medical Review Manager

Job Description

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven.  We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work.

Must Have

Indegene is looking for a US-based Medical Affairs Professional with Medical Review experience to serve as medical representative as part of the US Medical, Legal, Regulatory (MLR) review team. 
Responsibilities:
•    Serve as the medical delegate on US Medical, Legal, and Regulatory (MLR) review committee, which is responsible for review and approval (Sign off) of all 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 US 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 US marketing and medical teams to ensure compliance with company policies and global standards for ethical promotion and scientific interactions.
•    Support US marketing and medical colleagues through guidance and provision of information on company products, brand messages and claims that are in compliance with US regulations.
•    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 Medical Affairs Leads and Medical Directors to ensure alignment of company medical strategy.  This includes escalating materials accordingly when guidance is required.  

Requirements:

Educational and experience related:
•    Candidate with medical degree/medical doctor qualification (MD)
•    3-5 years of industry experience in Pharmaceuticals within medical affairs, medical communications, or medical information teams
•    US board certified medical professional with good clinical experience preferred, internal medicine specialist with specialization in pain management will be preferred 
•    1-2 years of prior work experience working as a medical delegate in the pharma MLR committee (providing medical sign-off on Promotional and Non-promotional materials)
Additional work related:
•    Can work as collaborative team member who provides compliant, medically accurate solutions - while improving marketing messages for consumer, healthcare provider and managed care materials. Strong ability to work independently, with flexibility and a strong ability to connect and work with multidisciplinary teams
•    Good understanding of FDA and international regulations on advertising, promotion and scientific exchange.
•    Familiarity with Veeva PromoMats and Veeva MedComms platforms preferred
•    Excellent multitasking, project management, organizational skills and attention to detail
•    Solution oriented, positive attitude and excellent interpersonal skills; as well as oral and written communication skills.
•    Experience working as part of a multi-national teams
•    Ability to work cross-functionally with marketing, legal, regulatory, medical affairs 

Good to have

EQUAL OPPORTUNITY

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.