Senior Medical Manager

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Medical Affairs Group Job Sub Function: Medical Affairs Job Category: Scientific/Technology All Job Posting Locations: Kiev, Kyiv, Ukraine Job Description: To create value through generation, interpretation and communication of medical and scientific information and creative scientific ideas converted into marketing practices offering competitive advantage to the company. Interacts with a variety of divisional and/or corporate departments such as marketing and sales, legal affairs, regulatory affairs as well as PR. External co-operation with relevant national advisory boards, peer groups, industry associations and customers (doctors in hospital, etc.) is required. Ensuring compliance in all promotional activities with local laws, regulations, J&J standards and Scientific Engagement. EXTERNAL COMMUNICATION: Opinion Leaders, Health Professionals, Clinical Study Staff, Organization Firms, Advertisement Agencies, Health Authorities, Patient Organizations, Medical Associations. KEY ACCOUNTABILITIES 1. Primary member of the value team. Assumes active role in developing new strategies and improving current strategies in the Therapeutic Area he/she is responsible for. Collects and consolidates medical data for this purpose and presents scientific data of highest ethical standards at value team meetings. Maintains up-to-date scientific data. Works closely with the other departments concerned with the Therapeutic Area he/she is responsible for to consolidate strategies. Drives the delivery of all Medical plans and activities to agreed timelines, budget, and quality standards in alignment with internal Policies/Standards and external regulations. 2. Ensures that company strategies and practices in the medical area comply with the HCBI, national and global ethical procedures. Reviews the promotional materials and activities of competitors and notifies the related company, MoH and Pharmaceutical Manufacturers’ Association if not compliant with the local laws, regulations and local code. Assumes active role in identifying and organizing the contents of medical programs (education programs, participation in international/national congresses, advisory board meetings, courses, disease awareness programs, etc.), follows up on these and evaluates the outcomes. Organizes medical education activities and attends these educations to contribute to the realization of product plans. 3. Prepares and conducts educations to provide field teams with adequate and necessary medical information, follows up on these and evaluates the outcomes. Makes plans for, and updates education programs to ensure their continuity. Collects and evaluates scientific data on rival products/product groups and accordingly updates data on his/her product groups to effectively manage marketing strategies and activities. Contributes to market research activities that are planned to implement marketing strategies by providingscientific evaluation. Ensures that market research is conducted within the ethical limits and rules, particularly those relating to PV and confidentiality of patient data. 4. Establishes firm and continuous communication with opinion leaders by way of scientific platforms such as national/international congresses and medical education activities. Builds coordination among opinion leaders, associations, and health authorities to develop medical education activities. Visits physicians as planned in the i-connect system to be in constant contact with them and makes clinical presentations to share product-related information. 5. Provides medical support in line with company strategies for updates to SmPC/patient information leaflets for authorized drugs or for the preparation of SmPC/patient information leaflets for drugs pending authorization and provides data for reimbursement formalities. Prepares medical contents of authorization and reimbursement files. For this purpose, accompanies the Authorization and Health Economy Group in their presentations and visits. Holds regular meetings with the Regulatory Affairs, Health Economy and Business Units departments to maintain close cooperation and provides them with scientific data on diseases and products to ensure continuous improvement and development. 6. Provides medical contribution to the preparation of promotional material. Checks all materials related to a given product/disease, approves their consistency, scientific accuracy and validity, and ensures that the scientific contents of promotional materials comply with the HCBI policies, Ministry of Health regulations, and IFPMA/ EFPIA rules. Participates in, and provides support to, company or product promotion activities. Assists in the Medical Approval process to ensure the compliance of promotional materials and activities with local laws, regulations and J&J standards. 7. Receives and follows up on information from doctors with respect to drug safety and forwards such information to the Pharmacovigilance officer in accordance with the rules. Contributes to the action plans and implementations developed by the PV and Quality Assurance departments in response to alerts about drug quality and safety reported by local or Global sources. 8. Carefully evaluates requests from field staff or doctors relating to his/her area of responsibility, responds to these requests and follows up on the process of recording these in the med-info system. Reviews feedback from field staff or physicians, thinks proactively about objections/issues that may arise in relation to a product, investigates the matter and contributes to the solution of the problem. 9. Provides support to clinical research teams for planned/ongoing and completed clinical trials (selection of investigators and sites, investigator meetings, collective visits, identification of the congress/journal where the data will be presented, etc.) and helps establish communication with investigators within the framework of clinical trial activities. Plays an active role in the development of global and local trial protocols. Works in coordination with the clinical trial teams in adapting such protocols. Works in coordination with the Therapeutic Area Leader during local studies to review posters, summaries and complete texts of the clinical trial, providing support and coordination. Leads the NPP, independent research support (IIS) and RWE (Real World Experiences) processes andimplements these in accordance with MH regulations and HCBI procedures. Completes trainings on the Medical Affairs Compliance Process and ensures that such trainings have also been completed by concerned MSLs. 10. Plays an active role in preparing, managing and monitoring the medical budget for a given product. Takes necessary actions to complete activity and participant approval processes in line with the workflows in the i-connect system and works in coordination with relevant teams. Ensures that agreements are duly signed with speakers/moderators taking part in Medical Education Activities prior to the activity. Ensures that information required for this purpose is ent