OVERALL PURPOSE OF JOB:

• Responsible for Medical Affairs (MAF) strategy and plan in the assigned therapeutic area/product(s).
• Directs the operational function in Medical Affairs to achieve organizational objectives.
• Ensures Medical and Scientific Leadership in the therapeutic area of responsibility by implementing Medical Education and Proactive Communication Programs and nurturing professional relationships with thought leaders.
• As Clinical Advisors? (CAs) / Medical Scientific Liaisons? (MSLs) Manager is responsible for leading, coaching, and developing CAs (and the MSL function) to be therapeutic area scientific experts, responsible for discussing our products, treatment trends and studies in the therapeutic areas in which we are involved so they are considered to be trusted scientific counterparts and are seen to be the scientific face of Janssen.
• Responsible for providing scientific guidance to therapeutic area/products as member of Country Value Team (CVT) and to other internal stakeholders, i.e. Marketing, Regulatory, Health Economics Market Access Reimbursement (HEMAR), Medical Information, External Affairs, among others.
• Ensure and promote collaboration of assigned personnel within therapeutic area (TA).
• 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 studies, including Phase IIIb, Phase IV trials, non-interventional studies, registries, and other Real World Evidence (RWE) projects.
• Ensures the adequate management of Investigator Initiated Studies (IIS) in the designated area.
• Ensures the development of a publication plan.

MAIN ACTIVITIES/TASKS:

General Activities

• Responsible for the design and oversight of development and implementation of MAF strategy in the assigned therapeutic 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 Advisors/ Medical Scientific Liaisons? Management

• Team management & securing execution in field:
  • Set up and continuously lead a team of professional and highly effective collaborating CAs/MSLs.
  • Develop CA/MSL strategy and budget plan and gain commitment from internal medical and business partners to achieve organizational goals (in alignment with Therapeutic Area/Business Unit (TA/BU) goals).
  • Ensure execution of above-mentioned strategy covering all relevant CA/MSL activities but especially core activities such as Leading Specialist (LS) interactions and Medical Education.
  • Support and coordinate CAs/MSLs? involvement in IIS studies, NPPs, EAPs & PSPs, RWE/Registries.
  • Support CAs/MSLs in developing and maintaining close working relationships and alignment with commercial colleagues whilst adhering to Health Care Business Integrity (HCBI) guidance.
• Synthesize therapy knowledge and data to ensure Janssen TA strategy is aligned, implemented and course correct where necessary.
• Monitor competitor scientific activities to understand their ongoing strategies and discuss those with the relevant internal stakeholders.
• Collects scientific & treatment trends and provides feedback as input for strategic TA & medical teams (also mentioned in part "internal collaboration").
• Training & individual development:
  • Active coaching to raise individual`s self-awareness and foster consecutive skills to find problem solutions or methods/techniques to improve for oneself.
  • ?on the job? observation & immediate feedback loops (including co-visits) to ensure that CAs/MSLs interact effectively with LSs, other Health Care Professionals (HCPs) and other relevant stakeholders to evaluate individual CA?s scientific and professional engagement skills and identify areas for development.
  • Provide support to enable their team to undertake their activities. This may take the form of general or technical advice and will also include facilitating their personal development as well as facilitating progression through the organization.
  • Identify training needs of team members and provide solutions. Guarantee a good coordination between the CA/MSLs team members, sharing best practices and working as a virtual team.
  • Ensure skills and processes are in place for CAs/MSLs to identify, document and share medical insights with relevant colleagues.
  • Identify and address knowledge and skills gaps and ensure that CAs have access to training and resources to:
    • Continually develop their scientific expertise and knowledge including latest scientific data, current therapeutic guidelines, scientific activities and medical progress.
    • Continually enhance and improve their professional engagement skills.
  • Together with his direct reports builds, follow and keeps up to date the development and career pathway of CA/MSL.
  • Is the main contributor in keeping up to date CA training matrix and individual training plan.
• Main interactions
  • Internal collaboration & enhancement of MSL lead role:
    • Ensure that MSLs are effectively collaborating with internal [specifically Global Clinical Operations (GCO)] and external stakeholders [e.g. Contract Research Organizations (CROs) and others] to contribute to the planning, set up and management of clinical trials and IIS requests.
    • Work with other local CA/ MSL Managers to identify and share best practices and drive consistency in CA/MSL activities across TAs and teams. Share best practices with and from regional and global teams.
    • Support CA/MSLs to contribute to core medical strategies and the development and implementation of the local MAF product plan (in collaboration with Country Medical Team).
    • Represent the interests of CAs/MSLs to local and regional organizations (e.g. local MAF leadership and MSL Council).
    • Build and maintain understanding of relevant Company processes, systems and compliance requirements.
  • External:
    • LS interactions during co-visits, congresses/scientific meetings and Medical Education events.
    
    

Clinical Research Activities

• As Therapeutic Area Head has responsibility for the strategic decisions for a TA at local or regional level with respect to clinical studies and usually is involved in the approval of projects or key decisions during the conduct.
• As Study Responsible Scientist (SRS) has primary responsibility for the applicable medical activities and the oversight and management of applicable individual Company-sponsored/supported studies on products in the TA.
• As Program Coordinator, in collaboration with RWE Manager, provides program management for a product, a disease area or all products in a country or region within medical affairs and drives interactions with internal (e.g. GCO MAO) and/or external project execution partners.
• The scope of those responsibilities may involve interventional and non-interventional trials to support the development and marketing of the medicines already authorized and can include local pharmacovigilance/epidemiology studies according to Regulatory and Marketing needs and local legislation.
• Actively participates in protocol design for local trials and supports and supervise the following activities interacting with GCO: protocol internal approval according to Janssen EMEA procedures, Medical Review Plan development, Medical Review activities study feasibility, site selection, study documents review, trial set-up, oversight on study progress until site closure, participation in investigator?s meetings, elaboration/ revision of final study reports and publication.
• 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 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.

Pharmacovigilance

• Provides support to Local Safety Officer (LSO) in pharmacovigilance issues related with the respective therapeutic area, including the scientific input in the review of Adverse Events (AEs) 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 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 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 pharmacovigilance to provide safety-related regulatory communication (e.g. response to request for information from Local HA).

Medical Information

• 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 Core Medical Information Responses (CMIRs) when required.
• Reviews and approves local CMIRs.
• Develops scientific documents in collaboration with Medical Information to respond to unsolicited queries.
• Answers to Medical Information requests in coordination with Local Medical Information Unit.

Medical Education

• Cooperates in the implementation of mid-term and long-term business plans with regard to Medical Department in compliance with the HCBI 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 HCPs) as well as the provision of scientific information to HCPs, patients? associations and medical societies.
• Reviews and approves Medical Education materials (developed by direct reports, as applicable, e.g., MAF Managers, Medical Advisors, Medical Education 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. Product Information ? SmPC, PIL) and in clarifying any issues requested by the regulatory HAs.
• Coordinate the delivery of a comprehensive pharmacovigilance service and maintain standards for regulatory reporting requirements.

Marketing & Sales Support

• Participate actively in medical training and development of sales representatives 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 representatives and external customers cooperating in the documentation service.

Market Access Support

• Support the Market Access activities in the TA including the scientific assistance in the discussion of price and reimbursement strategies, preparation and review of reimbursement files, attending specific meetings or in clarifying any scientific issues requested by the Health Technology Assessment (HTA) authorities.

Compliance

• Ensures safety reporting requirements (timely AE/PQC reporting) as set out in Company policies and SOP?s are met and appropriately managed when planning projects, developing materials, executing projects and contracting vendors.
• Ensures Health Care Compliance (HCC) and legal requirements are fully understood, appropriately managed and complied with when planning projects, developing materials, executing projects and contracting vendors.
• Ensures high level of understanding of Johnson & Johnson (J&J) compliance policies, EFPIA and FCPA corruption laws.

Qualifications

SPECIAL REQUIREMENTS:

• Fluency in the national language(s) and the English language required.
• Deep Therapeutic Area Knowledge, including deep level of therapy knowledge and competitor activity, and continuous update by attending congresses, courses and industry meetings, reading publications and discussing therapy area with colleagues to keep up to date with developments within the pharmaceutical industry and pharmaceutical medicine.
• Business Acumen Skills & knowledge on Crafting a MAF strategy:
  • Proven deep insights & track record in health care environment, customer interaction and evidence generation; finance matters, budget planning & FTE planning are also beneficial.
  • This will translate into:
    • Collaboration & alignment with sales force while meeting all HCBI laws & while distinguishing from sales representative role.
    • Collaboration with other internal medical colleagues & also with the clinical team (GCO site managers).
    • Support the development of compliant materials.
    • Secure appropriate budget for CAs/MSLs to optimize their participation in scientific congresses, and functional / therapeutic training.
    • Manage team specific budget and strategically-aligned LS management budget, within a team of MSLs, as determined locally.
• Coaching & Managerial Knowledge & Skills:
  • Demonstrates capabilities for a field based medical role and proven competency at the senior CA level.
  • Proven ability to lead and coach scientific/medical personnel at all skills and knowledge levels and/or structured training when new in role: e.g. First Line Leader, Training & Essential Coaching Conversations, Integrity Communication or other.
  • Proven ability to interpret, communicate and implement medical/scientific strategies to direct reports.
  • Strong leadership/people management mindset, personal integrity and demonstrated customer focus.
  • Strong knowledge of the pharmaceutical market, encompassing medical strategies and market trends.
  • Excellent interpersonal, communication, negotiation and presentation skills (J&J trainings can be used).
  • Must be able to organize, prioritize, and work effectively on multifunctional teams in a constantly changing environment and to motivate a team to do the same.
• Leadership competence:
  • Ensures a high level of professionalism & competencies through recruiting, coaching & development of his individual employees but also ensures their effective collaboration.
  • Acts as a role model in terms of a Credo based behavior incorporating and living all four leadership imperatives
  • Realizes potential(s) & fosters individuals strengths: (CONNECT, LEAD & SHAPE):
    • In close exchange with his local/regional MSL lead colleagues he actively shapes the CA/MSL role`s evolution & ensures the mandatory level of uniformity between different TAs.
    • Supports CAs/MSLs in developing and maintaining close working relationships and alignment with e.g. commercial colleagues whilst adhering to HCBI guidance.
    • Represents the interests of CAs/MSLs to local and regional organizations (e.g. local MAF leadership and MSL Council).
    • As a permanent & proactive member both of the local MAF strategy team and the local CVT/product team as ambassador of the CAs/MSLs.
    
    

Experience (preferential)

• 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.

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.

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we in Portugal are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential.

No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means ?You Belong?!

Primary Location
Portugal-Lisbon-Lisbon-
Organization
Janssen-Cilag Farmaceutica, Lda. (7290)
Job Function
R&D
Requisition ID
2105963354W