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

Responsibilities:
Serve as the content review SME, which is responsible for reviewing 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 market.
Review materials and ensure data included are accurate, within context, and presented in a fair/scientifically balanced manner and aligned to the product/brand tonality. 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.
Understanding US FDA requirements is essential. Support US marketing and medical colleagues through guidance and provision of information on company products, brand messages and claims that follow 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 in collaboration with Marketing and Brand team supporting review and approval of promotional and medical materials; and be willing to support on ad hoc global medical information/communication/affairs projects.
Participation in MLR discussions and submissions.
 
Requirements:

Advanced bioscience or pharmacy/medical qualification (Pharm.D., MBBS/MD, Ph.D ).
Total 4-8 or more years’ experience in pharmaceutical within medical affairs, medical communications, or Marketing teams
2-4 years of prior work experience working as a medical reviewer in the pharmaceutical company/agencies. 
Can work as collaborative team member with strong communication skills who provides compliant, medically accurate solutions - while improving marketing messages for consumer, healthcare providers and managed care materials. Strong ability to work independently, with flexibility and a strong ability to connect with multidisciplinary teams.
Strong scientific acumen and ability to grasp complex therapeutic areas, including - Immunology, Cardiovascular, Renal, Neurology, and Oncology would be preferred
Experience in dealing with the requirements of US FDA regulatory framework. and their practical implementation regarding the creation and approval of advertising materials and non-advertising materials.
Good multitasking, project management, and organizational skills.
Solution oriented, positive attitude and excellent interpersonal skills; as well as oral and written communication skills.
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.