Apolis
Medical Reviewer Job Description:
Summary:
Indegene is looking for a bilingual Medical Affairs Professional with Medical Review experience to serve as medical representative as part of the Chile Medical, Legal, Regulatory (MLR) review team. Responsibilities: Serve as the medical delegate on Chile 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 CHILE 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. dvise on materials and events designed and produced by Chile marketing and medical teams to ensure compliance with company policies and global standards for ethical promotion and scientific interactions. Support Chile marketing and medical colleagues through guidance and provision of information on company products, brand messages and claims that are in compliance with CHILE regulations. Ensure standards for promotional claims and non-promotional product information sharing, ensuring promotions and communications adhere to regulations and support appropriate Chilee 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: dvanced bioscience or pharmacy/medical qualification (Pharm.D., MD, Ph.D ). Total 6-8 or more years' experience in pharmaceutical within medical affairs, medical communications, or medical information teams 2-4 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). 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. Strong scientific acumen and ability to grasp complex therapeutic areas, including rare diseases or orphan drug products. Good understanding of Chilean 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 bility to work cross-functionally with marketing, legal, regulatory, medical affairs Bilingual candidate with Spanish and English expertise
Indegene is looking for a bilingual Medical Affairs Professional with Medical Review experience to serve as medical representative as part of the Chile Medical, Legal, Regulatory (MLR) review team. Responsibilities: Serve as the medical delegate on Chile 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 CHILE 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. dvise on materials and events designed and produced by Chile marketing and medical teams to ensure compliance with company policies and global standards for ethical promotion and scientific interactions. Support Chile marketing and medical colleagues through guidance and provision of information on company products, brand messages and claims that are in compliance with CHILE regulations. Ensure standards for promotional claims and non-promotional product information sharing, ensuring promotions and communications adhere to regulations and support appropriate Chilee 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: dvanced bioscience or pharmacy/medical qualification (Pharm.D., MD, Ph.D ). Total 6-8 or more years' experience in pharmaceutical within medical affairs, medical communications, or medical information teams 2-4 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). 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. Strong scientific acumen and ability to grasp complex therapeutic areas, including rare diseases or orphan drug products. Good understanding of Chilean 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 bility to work cross-functionally with marketing, legal, regulatory, medical affairs Bilingual candidate with Spanish and English expertise