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 https: //www.jnj.com

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

For our pharmaceutical sector, we are currently recruiting a Medical Affairs Manager (M/F) – Oncology/Lung on a permanent contract to be based in our Madrid office.

Essential Job Duties and Responsibilities

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.

To increase awareness and understanding of Janssen 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.

MAIN ACTIVITIES/TASKS:

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. MAO) 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/MAO, 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.

• 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.

Observes and promotes all regulatory requirements as defined in applicable regulations, rules and procedures established by the Company, including but not limited to Health Care Business Integrity and Pharmacovigilance.

Report any AEs, PQCs and/or special situations to the local designated person (e.g., LSO/designee), local Call Center or electronic collection tool within one (1) Business Day. In the event of a public holiday, measures must be taken to ensure reporting no later than Calendar Day Three (3).

Ensure inspection readiness with respect to individual personal training compliance, and availability of recent Summary of Experience (SOE) and individualized Job Description.

Additionally, for all employees involved in Research Related Activities (RRAs):

• Ensure safety reporting requirements (timely AE/PQC reporting) as set out in company policies and SOPs (Standard Operating Procedures) are met and appropriately managed when planning projects, developing materials, executing projects and contracting vendors.
• Ensure HCC and legal requirements (Fair Market Value, Transfer of Value rules, Promotional Materials rules) are fully understood, appropriately managed and complied with when planning projects, developing materials, executing projects and contracting vendors.

Minimum Qualification

Scientific degree: Medical Doctor, Pharmaceutical or Nature Science university degree.

Minimum 4 years of Experience in Medical Affairs, with deep knowledge of the therapeutic area. Strength in research and interpretation of medical data (including statistics).

Relevant work experience, 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 of, and adherence to, Johnson & Johnson Credo values and International Health Care Business Integrity Guide.