Caring for the world, one person at a time’… inspires and unites the people of Johnson & Johnson. We embrace research and science – bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Janssen Pharmaceutical joined the Johnson & Johnson group in 1961. Today, Janssen is one of the most innovative pharmaceutical companies in the world.
OVERALL PURPOSE OF JOB:
- Responsible for Medical Affairs strategy and plan in the assigned therapeutic area/product(s).
- Directs the operational function in Medical Affairs to achieve organizational objectives.
- Responsible for the design and oversight of development and implementation of studies, including Phase IIIb, Phase IV trials, non-interventional studies, registries, other RWE projects.
- Ensures the adequate management of Investigator Initiated Studies (IIS) in the designed area.
- Ensures the development of a publication plan.
- Ensures the implementation of medical educational programs and materials promotional and reporting materials for products, including maintaining professional relationships with thought leaders.
- To coordinate with the Medical Affairs Managers, Medical Advisors and Clinical Advisors, the successful implementation of the Medical Affairs strategy at regional level.
- Responsible for providing scientific guidance to therapeutic area /products as member of Country Value Team and to other internal stakeholders, i.e. Regulatory, HEMAR, Medical Information, External Affairs, among others.
- Ensure and promote collaboration of assigned personnel within Therapeutic area.
- To support the coordination of safety reporting as required for Marketing Authorization Holders (MAH) and/or study sponsor, as applicable.
- Responsible for the design and oversight of development and implementation of medical affairs strategy in the assigned area/product(s).
- Manages the design and implementation plans of medical affairs program, including identification of critical paths, budget development and tracking of all projects.
- Manages and delegates work of direct reports and establishes accountability for assignments.
- Participates or ensure participation and member of the EMEA Medical Affairs Product Team (EMAPT).
- Responsible for hiring, training, development, management and performance evaluation of direct reports.
- Maintains collaborative working relationship between medical affairs and internal stakeholders to deliver timely and expert support to product development.
- Manages budget, contract negotiation and oversight of vendor activities.
- Complies with own training requirements to perform duties of own job.
Clinical Research Activities
- Supports the clinical trials program in the respective business area. The scope of those responsibilities may involve interventional and non-interventional trials to support the development and marketing of the drugs already authorized and can include local pharmacovigilance/epidemiology studies according to Regulatory and Marketing needs and local legislation.
- Active participation protocol design for local trials and support and supervision of the following activities interacting with GCO: protocol internal approval according to Janssen EMEA procedures, study feasibility, site selection, study documents review, trial set-up, oversight on study progress till site closure, participation in investigator’s meetings, elaboration of final study reports and publication.
- Ensures medical (safety) monitoring as Study Responsible Physician for local studies.
- Reviews and approve IIS proposals.
- Ensures that all the trials are done according to annual plans, agreed with central structures in Janssen EMEA MAF and also with commercial structures in Portugal aiming to reach the objectives both quantitative and qualitatively, including number of studies, dates and budget that were originally forecasted.
- Ensures that trials/registries are conducted according to all applicable guidelines, regulations, company procedures and high ethical/quality standards.
- Provides support to LSO in Pharmacovigilance issues related with the respective therapeutic area, including the scientific input in the review of ADR reports occurred in Portugal and PSUR elaboration.
- Supports the coordination of safety reporting requirements as required for MAH and/or study sponsor, as applicable.
- Responsible for the review and support in collection and reporting of Adverse Events (AEs) and pregnancy reports obtained through spontaneous reporting, solicited reports, clinical study, Local Health Authorities (HAs) and other potential sources.
- Assists with initial quality review and assessment of individual cases when required.
- Undertakes site visits for special interest cases as requested by LSO.
- Provides input into safety sections of local protocols as required and coordinates the provision of support for third party safety agreements at the local level.
- Assists in the provision of local data as required to support the preparation of Safety Summary reports (PSURs, ASR, etc).
- Where applicable, supports the Qualified Person (QP) for PV to provide safety-related regulatory communication (e.g. response to request for information from Local HA).
- Implements policies and procedures for development and provision of medical information pertaining to the company’s products for internal use by customer and by government.
- Analyzes publications and contributes to the development of local CMIRs when required.
- Reviews and approves local CMIRs.
- Develops scientific docs in collaboration with Medical Information to respond to unsolicited queries.
- Answers to Medical Information requests in coordination with Local Medical Information Unit.
Medical Education Support
- Cooperates in the implementation of mid-term and long-term business plans with regard to Medical Department in compliance with the Health Care Business Integrity processes.
- Contributes actively to Janssen’s strategic planning and decision-making.
- Cooperates in the development of the annual medical education plan (therapeutic categories,
educational subjects, scientific fields and respective health care professionals) as well as the provision of scientific information to health care professionals, patients’ associations and medical societies. Review and approve Medical Education programs and materials (developed by Medical Affairs Managers, Medical Advisors or Clinical Advisors).
- Reviews and approves Medical Education materials (developed by direct reports, as applicable, e.g., Medical affairs Managers, Medical Advisors or Clinical Advisors).
- Develops relationships with key opinion leaders (KOLs) ensuring that the market appreciates the company’s social and corporate image.
- Attends scientific events (conferences, educational programs, other events) in order to enhance the corporate image and identify the training and information needs of the medical scientific community.
Regulatory Affairs Support
- Support the Regulatory Affairs activities in the therapeutic area including the review of documents (e.g. PIL, SmPC), and to provide scientific support for reimbursement files, and in clarifying any issues requested by the regulatory authorities.
- Coordinate the delivery of a comprehensive PV service and maintain standards for regulatory reporting requirements.
Marketing & Sales Support
- Participate actively in medical training and development of sales reps and also other internal elements of different areas as long as it is necessary, including active participation in sales conventions.
- Provide support for the daily activity of the respective commercial area /unit, in order to allow all commercial areas to have the necessary support and technical consulting, cooperating with them and providing all necessary resources to the execution of the policies and commercial objectives, established by the company management. This includes to participate and to support clinical sessions, to cooperate in the elaboration of promotional materials, and to answer questions forwarded by the sales reps and external customers cooperating in the documentation service.
- Observes and promotes all regulatory requirements as defined per applicable regulations, rules and procedures established by the Company, and notifies any violation or deviation to
the immediate supervisor or appropriate authority.
- Assures that all assigned personnel have the appropriate training and qualifications to perform all duties and responsibilities.
- Complies with own training requirements to perform duties of own job.
- Fluency in the national language(s) and the English language required.
- Deep knowledge of the therapeutic area, scientific acumen and communication skills.
- Strategic business vision.
- Solid business acumen and pharmaceutical market experience.
- Leadership and management skills.
OTHER FEATURES OF THE JOB:
- Qualified Medical Doctor and experience in pharmaceutical regulations and R&D processes.
- Residency (or experience as internship) of Internal Medicine, Haematology, Oncology, Psychiatry/Neurology, Anti-Infectives and/or other medical specializations.
- The role holder will be expected to be based in their current country of residence and includes national and international travelling.
ESSENTIAL KNOWLEDGE & SKILLS:
- Good communication and personal relationships skills.
- Leadership and motivation capabilities for specific projects. Able to gather and transmit information in a clear and simple way.
- Teamwork mind orientation.
- Organized and accurate in the execution of all tasks.
- Persistent, dynamic, creative, looking for opportunities and flexible.
- Able to use new technologies like the Internet as a valuable tool on his work.