Medical Reviewer

Medical Reviewer (German Speaking)

Please note: This is a contractual part time role where we would require your Medical Reviewer expertise with specific projects only. The projects will come in on ad-hoc basis. This role will require you to be fluent in German language.

Who are we?

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 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 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. If this excites you, then apply below:

Summary:

Indegene is looking for an EU (Germany) based Medical Affairs Professional with Medical and Compliance Review experience. The medical reviewer will work with Indegene’s pharmaceutical client partner and serve as a medical representative of company’s Local Medical, Legal, Regulatory (MLR) review team.

Background : Indegene partners with pharmaceutical (top 20) and emerging biotechnology firms to provide effective, AI-enabled material review and compliance solutions. We provide comprehensive medical, regulatory, and editorial review services as well as operations support through a team of 350+ experienced professionals. We have a good knowledge of key market regulations and codes of practice and our span of operations covers North American, European, and Asia-Pacific regions.

Responsibilities of Medical Reviewer: Serve as the medical delegate on 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 German 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. Ensure translation accuracy for localized material in German language (against global version) and adherence to approved local label (indications, disease state description, population etc. per local label) Advise on materials and events designed and produced by marketing and medical teams to ensure compliance with company policies and German 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 (Local 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 international 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

Requirements:

Advanced pharmacy/medical or bioscience qualification. Experience in pharmaceutical industry within medical affairs; experience working on a cross-functional Medical, Legal, Regulatory (MLR) review committee is preferred. Good knowledge of German and English as well as extensive knowledge of MS Office Good knowledge of international and EU and Germany’s compliance regulations (HWG, AMG, UWG), codes of practice and their practical application. Strong scientific acumen and ability to grasp complex therapeutic areas. 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

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, 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.