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Medical Reviewer Lead

Indegene, Inc. Remote ,OR
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Medical Reviewer Job Description:

Summary: 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 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.

· Work under the guidance of Medical Information & Medical Review team; work collaboratively with team supporting International review and approval of promotional and medical materials; and be willing to support on ad hoc global medical information/communication/affairs projects.

 

Requirements:

· Advanced bioscience or pharmacy/medical qualification.

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

· Strong scientific acumen and ability to grasp complex therapeutic areas, including rare diseases or orphan drug products.

· Good understanding of FDA regulations on advertising, promotion and scientific exchange.

· 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

 

Company Description
Indegene is a leading integrated scientific partner to global pharmaceutical and life sciences companies delivering a spectrum of marketing, medical, training, and research & analytics services.

Through an innovative and game changing business model, Indegene is growing rapidly across USA, Europe and the Emerging Markets. Indegene has a proven track record of delivery with 15 of the Top 20 global biopharmaceutical companies and has been routinely won prestigious industry awards including Hermes, RX club, Marcom and Webby for medical marketing and training initiatives.

Through a comprehensive suite of business technology solutions and platforms, we enable clients to transform Sales and Marketing, Research & Development, Medical & Regulatory management, Manufacturing Operations, Physician & Patient engagements effectively. Our suite of solutions and services leverage technology uniquely to solve some of the business problems in these domains.

Leveraging the depth of our scientific expertise, scale of operations, hybrid delivery model, global footprint and intellectual property, we deliver value across multiple dimensions including cost-effectiveness, ability to work with global teams and their local affiliates, and the ability to deploy cutting edge innovative platforms for R&D and marketing. We are uniquely transforming the industry and building a new kind of partnership with our biopharmaceutical clients through three key differentiators: Cost Benefit; Value Addition and Innovation

Indegene, Inc.

Why Work Here?

Indegene is a strategic solutions partner to several of the Top 50 pharma/life sciences and healthcare organizations worldwide.

Indegene is a leading integrated scientific partner to global pharmaceutical and life sciences companies delivering a spectrum of marketing, medical, training, and research & analytics services. Through an innovative and game changing business model, Indegene is growing rapidly across USA, Europe and the Emerging Markets. Indegene has a proven track record of delivery with 15 of the Top 20 global biopharmaceutical companies and has been routinely won prestigious industry awards including Hermes, RX club, Marcom and Webby for medical marketing and training initiatives. Through a comprehensive suite of business technology solutions and platforms, we enable clients to transform Sales and Marketing, Research & Development, Medical & Regulatory management, Manufacturing Operations, Physician & Patient engagements effectively. Our suite of solutions and services leverage technology uniquely to solve some of the business problems in these domains. Leveraging the depth of our scientific expertise, scale of operations, hybrid delivery model, global footprint and intellectual property, we deliver value across multiple dimensions including cost-effectiveness, ability to work with global teams and their local affiliates, and the ability to deploy cutting edge innovative platforms for R&D and marketing. We are uniquely transforming the industry and building a new kind of partnership with our biopharmaceutical clients through three key differentiators: Cost Benefit; Value Addition and Innovation

Address

Remote, OR
USA

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