Title: Medical Communication & Information Specialist
NJ, MX
Job Description
Must Have
Summary: Indegene is looking for a Mexico based medical communication & information professional to work on medical communication & information deliverables for their global clients and medical review of promotional and non-promotional materials. Key responsibilities would include developing and reviewing content for a variety of medical communications & medical information documents such as slide sets, videos, abstracts, posters, infographics, literature searches including review of promotional materials.
Responsibilities:
• Research, develop, and review content that is scientifically accurate, evidence-based, appropriately referenced, and complying with quality and regulatory standards. Responsible for authoring and reviewing medical and scientific documents including but not limited to abstracts, newsletters, posters, slide decks, videos, infographics, medical information letters, etc.
• 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
• 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 marketing and medical teams to ensure compliance with company policies and global 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 FDA regulations. Ensure standards for promotional claims and non-promotional product information sharing, ensuring promotions and communications adhere to regulations.
• Create medical information documents including, but not limited to, standard response documents (SRs), questions and answer documents (Q&As), and reactive slide decks by assessing and summarizing published medical and scientific literature. Update the documents at regular intervals and maintain a database of frequently used medical information documents as required
• Demonstrate expertise and knowledge of assigned therapeutic areas and a good understanding of pertinent disease state(s).
• Perform literature searches in Pubmed and Embase including formulating a search strategy, critically evaluating the validity of the scientific literature, data extraction, and data presentation that would support the creation of medical content and check for or obtain copyright permissions prior to internal or external use.
•
Good to have
Work on platforms and tools to support creation, review, management, documentation, analysis and tracking of medical information documents.
• Work with the medical information and medical affairs teams during congresses, product launches, and key data releases and ensure assigned work is completed as per the timelines and SOPs. Work collaboratively and develop a good working relationship with the Medical Affairs Leads and Medical Directors to ensure alignment of company medical strategy.
• Have a background and understanding of requirements for strategic communication planning, KOL profiling, scientific meetings (advisory boards, company sponsored meetings, congress symposia), disease-awareness programs, and training and development programs (internal and external).
• Respond to medical information requests (or inquiries) from internal and external customers and ensure the responses are medically and scientifically accurate, timely, balanced, and meet customers’ needs
• Respond to inquiries received via phone, email, internet or mail with high quality customer service and document the inquiry and response accurately and completely according to relevant Standard Operating Procedure (SOP) and regulatory guidelines.
Requirements:
• Advanced bioscience or pharmacy/medical qualification (PharmD, PhD, MD, any life science background).
• Minimum of 2-3 years of scientific writing/content writing/promotional review experience in research, life science and pharmaceutical companies, for example, within medical affairs or medical information teams, or medical communications agency experience. Specific medical communication & information and promotional review experience is preferred.
• Strong accountability, interpersonal and organizational skills, and the ability to work in a cross-functional team environment.
• Knowledge of regulatory guidelines affecting the dissemination of medical communication & information and product promotion.
• Excellent verbal and written communication skills and willingness to travel on as needed basis.
EQUAL OPPORTUNITY