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Job Description:

We are currently looking for a Medical Affairs Manager (M/F) – Immunology/Rheumatology to be based in our Madrid office on a permanent contract.

OVERALL PURPOSE OF JOB

To plan, coordinate, and execute Medical Affairs Plan, including research and publication programs conducted by Medical Affairs.

To be a therapeutic area scientific expert and to maximize company product value through high scientific quality communication with Leading Specialists in Rheumatology.

To increase awareness and understanding of J& J products and processes to internal/external customers.

To design local epidemiological studies and scientific publications according to the Company strategy, to assess and discuss the IIS initiatives, collaborative studies and other RWE projects.

To define and implement medical education strategy for assigned therapeutic areas on behalf of J& J IM Spain, allowing Healthcare Professionals to make more informed decisions for their patient care within the therapeutic and disease areas of strategic importance to the organization.

To prepare the launch of future drugs in the area. To conduct proper trainings in the disease area for internal staff. To work with Marketing locally closely in the design, approval and dissemination of promo materials. To design and elaborate MedEd materials.

MAIN ACTIVITIES/TASKS:

Medical Affairs:

To keep abreast of the medical and scientific knowledge:

• Continuously update their knowledge of products, patient’s treatment trends and clinical activities and studies conducted within the therapeutic area in their region.
• Provides clinical and technical support to physicians, nurses and other medical professionals on company products and services.
• Provides feedback to scientific inquiries from the healthcare community and customer concerns about products and their use.
• Educates customers on clinical use of diagnostic and interventional products
• Support PV/Regulatory requests in terms of scientific advice and information to solve complaints/questions from physicians and other medical professionals

To plan, coordinate and follow up Medical Affairs Plan, including studies (i.e.: post approval studies, registries, early access programs, compassionate use, non-registration studies) and publication of the results and other RWE projects:

• To develop the concept and protocol, aligned with strategic interests of the company, and therapeutic area.
• To support study execution in collaboration with Operational groups (i.e. MADU and CROs including budget control, contract negotiation and oversight of vendor activities.
• Participates in the company's drug surveillance program including follow-up of adverse reaction events.
• Conducts quantitative and qualitative data analysis for Phase IV trials.
• Facilitates understanding of clinical trial data.
• To ensure, coordinate and participate in the publication of results and scientific data.

To evaluate, discuss and follow-up investigator-initiated trials and collaborative trials in collaboration with Medical Scientific Liaisons/other Medical functions/MADU, following company procedures.

To foster other different ways of scientific collaboration with stakeholders (ie. Data Base Enhancement/Database Profiling/Database research).

Support to company commercial objectives, such as marketing and communication strategies i.e. promotional materials & activities, ensuring compliance with the necessary Codes of Practice and Laws governing the promotion and sale of medicines.

To work proactively (ie. by initiating discussions around areas of concern) and creatively ensure dissemination and understanding of key company messages, particularly those with scientific, medical or clinical content.

To develop and maintain a contact network with Leading Specialists in Rheumatology.

• Understand their needs, key value drivers, practical treatment patterns and scientific activities within therapeutic area.
• Through scientific interactions, communicate medical benefits of products and contribute to foster innovative approaches.

To collaborate with Medical Education manager and MSLs in the development of Country Medical Education activities.

To collaborate with MSL manager and MATAL in the MSL plan development and implementation of MAF plan in the field.

To organize and participate in Advisory Boards in cooperation with other positions in the Marketing/Medical Affairs Department as appropriate.

Scientific support of company Marketing and Sales Representatives:

• Provides medical and product training and scientific support to marketing and Sales Representatives in coordination with Training/Medical Affairs Department as appropriate.
• Act as scientific reference for MSLs/Marketing/Sales Representatives for any scientific query, in collaboration with Medical Information as appropriate.

Provision of scientific support to other company departments, including but not restricted to Marketing and Sales Representatives, Market Access, Government affairs, KAMs, PV, Regulatory and Patient Advocacy.

To work closely with the EMEA medical teams to ensure a free flow of information and ideas between the different teams, while aligning objectives.

To work closely with the Market Access and RWE local team to ensure a free flow of information and ideas between the different teams, while aligning objectives.

To collaborate, work proactively and lead strategic scientific discussion and training within de CVT.

Through scientific interactions, i.e. interactions with Leading Specialist and participation in congresses, courses..., gain valuable insight into treatment patterns, and scientific activities in the therapeutic area and provide input to the company Medical Affairs Plan / business decision-making.

To develop and manage Key Opinion Leaders with the aim of them becoming product/pathology advocates.

Medical Education:

Define and develop Medical Education strategy for defined therapeutic areas as part of the Country Value Team (CVT).

• Identify Educational needs and build Medical Education Strategy and Medical Education Plan, in close collaboration and with the approval of the Medical Education Steering Committee (MESC),
• Integrate product evidence and align with unmet medical needs in the assigned therapeutic area
• Improve the impact of scientific information on the clinical practices of healthcare professionals
• Seek for competitive advantage through analysis of the scientific evidence
• Maintain fluent communication and networking with EMEA Medical education leads, and with peers from other countries, to ensure alignment, influence EMEA plans, and communicate local needs.
• Identify and customize scientific statements for the target audience
• Align the Medical Education plan to the Life Cycle management of the Therapeutic Area

Communicate the medical education plan to all involved functions. Act as a link by communicating regularly between other roles within the medical department e.g. medical information, medical affairs and medical scientific liaison to ensure strategic alignment and consistency of activities

Implement strategy by developing educational materials in association with selected third-party partners (e.g. medical education, logistics and delegate handling agencies)

Develop and maintain influencer databases to assist with provision of speakers and/or delegates for educational, promotional or advisory board purposes using appropriate systems

Dissemination of approved educational, product and therapy area data to HCPs in face to face or meetings environment

Develop and implement metric systems that monitor “quality” of educational programs and activities to allow for continued improvement for subsequent events. Work closely with field support to administer all logistics where necessary

Analyze and be trained on different types of formats (eg Digital) to develop the best experience of Medical Education according to HCPs needs.

Analysis and periodic monitoring of the resources used in the MedEd activity to optimize them and ensure a correct investment.

Plan, organize and/or facilitate advisory boards on behalf of the company in strategic therapeutic areas where necessary (using third parties where appropriate) in collaboration with other Medical functions.

Establish and nurture key customer relations to broaden contact base and knowledge.

Evaluation and management of unrestricted Educational Grants. Assure compliance with all applicable laws, policies, and guidelines; in alignment with therapeutic areas of educational interest and taking budget into consideration.

Provide point of contact to align EMEA medical education activities. Influence the EMEA plans in provision of appropriate activities for the local operating company to ensure that the correct educational needs are being met.

Partner with Medical Societies and other professional bodies to ensure alignment of J& J IM Spain medical education activities by gaining accreditation.

Partner closely with Medical Scientific Liaisons and MSL manager to assure appropriate medical plan implementation. According to business needs and experience, serve as MSL team manager, setting objectives, providing leadership to deploy an effective team, and measuring success.

Through a thorough understanding of HCC/HCBI, the Code of Practice and local regulations, monitor the content of all educational activities/materials to ensure strict compliance with internal and external regulatory requirements

Minimum Qualification

• Scientific degree: Medical Doctor, Pharmaceutical or Science university degree.
• Deep knowledge of the therapeutic area, strength in research and interpretation of medical data (including statistics).
• Relevant work experience of +3 years minimum in Medical Affairs or similar function.
• Strong scientific acumen and communication skills in order to be accepted by Leading Specialists in peer-to-peer relationship.
• Highly customer focused with an awareness of the importance of business results.
• Innovative with the ability to coordinate and drive a complex and changing environment.
• Awareness and adherence to Johnson & Johnson Credo values and International Health Care Business Integrity Guide.
• Deep scientific knowledge in the therapeutic area.
• Driving License