Medical Affairs Advisor - Bad Homburg, Deutschland - ARTO

Beschreibung

The Company:

An international pharmaceutical company driven by innovation and the chance to make an important impact, with products distributed worldwide. You will get the chance to join an exciting company, to work with their innovative pipeline, and to bring encouraging new products to patients and physicians.

The Medical Advisor plays a pivotal role within the medical affairs, clinical development, and business unit brand teams, employing scientific and medical expertise alongside relevant clinical experience. Their primary objective is strategic planning to support the launch and commercialization of products, ultimately enhancing the overall customer experience. Here, "customers" encompass patients, healthcare providers (HCPs), and payers.

The Medical Advisor collaborates closely with Development teams, Therapeutic Area Program Phases, Early Phase/Clinical Pharmacology, and Translational Medicine teams throughout the entire drug development and clinical trial continuum. Specific duties include:

• Contributing to global and/or regional clinical/medical plans in their respective therapeutic area.
• Leading or contributing to the development, execution, and reporting of local and global clinical trials.
• Ensuring compliance with adverse event reporting requirements as per corporate patient safety protocols.
• Reviewing and providing input on protocols, study reports, publications, and data dissemination.
• Supporting the development of product labels, pricing documents, reimbursement strategies, and access initiatives.
• Engaging with regulatory bodies and government agencies.
• Conducting outreach medical activities targeted at the external clinical community, including thought leaders.
• Performing various medical activities to drive demand realization.

Furthermore, the Medical Advisor works closely with the Director-Medical and Business Unit Team Physician/Regional Medical Leader to align their activities with the strategic priorities of the respective business unit and global Medical Affairs, brand, and development teams.

Clinical Research Physician Responsibilities:

The Clinical Research Physician serves as a scientific resource for study teams, departments, and stakeholders as necessary. They ensure that all medical team activities comply with local and international regulations, laws, and guidance (e.g., FDA, ICH, CPMP), as well as Good Clinical Practices (GCPs), company standards, policies, and global quality standards. Additionally, they ensure alignment with the medical vision of the organization.

Primary Responsibilities:

As a Medical Advisor specializing in Haematology/Oncology, your primary role is to provide medical expertise across our product portfolio. You collaborate with affiliate, regional, and global teams to shape medical strategies and drive brand commercialization efforts.

Your responsibilities include:

• Maintaining detailed and current knowledge of the data related to the respective Molecule(s), ensuring informed contributions to medical strategies.
• Cultivating effective partnerships with various internal functions, including Pricing Reimbursement & Access (PRA), Clinical Operations, Corporate Affairs, Human Resources, Legal, Marketing, Medical Information, Global Product Safety, and Training.
• Developing strong relationships with clinicians, key influencers, and external groups to support brand initiatives.
• Understanding and anticipating the scientific information needs of local/regional customers, including payers, patients, and healthcare providers.
• Addressing customer inquiries promptly by leading data analyses and conducting new clinical or health outcomes research.
• Contributing to the development of medical strategies to drive brand commercialization activities.
• Providing scientific and medical expertise to the PRA organization, particularly in developing payer partnership programs and defending product value.
• Actively participating in strategic planning for currently marketed brands.
• Offering scientific and creative input and participating in the development, review, and approval of promotional materials for the brand team.
• Supporting the training of sales representatives, medical representatives, Medical Affairs Personnel (MAPs), and Medical Science Liaisons (MSLs).

Provision of Medical Expertise

• Ensure detailed, up-to-date knowledge of the data surrounding the respective Molecule(s)
• Input into regulatory submissions and Health Technology Assessments (HTAs)
• Assist Medical Information and Global Product Safety in the affiliate as requested, including out of hours calls
• Drive and take accountability for the process and content of scientific publications
• Provide initial and ongoing disease, product and competitor training for all Lilly employees
• Provide presentation to groups of HCPs and others as determined by business needs
• Participate at an early stage in the production of materials with substantial or critical medical content (e.g. detail aids, clinical slide sets etc.)
• Attendance of relevant internal and external meetings
• Scientific Data Dissemination/Exchange

Compliance and Education

• Knowledge of compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals. Review and approve promotional and non-promotional materials in line with the local compliance guidelines.
• Drive the response to challenges from competitors,
• Comply with Good Pharmaceutical Medical Practice, Good Clinical Practices (GCP) and comply with all local laws
• Support the planning of symposia, advisory board and medical meetings
• Support medical information associates in preparation and review of medical letters and other medical information materials.
• Support training of local medical/non-medical personnel – Medical lead for internal training
• Prepare or review scientific information in response to customer questions or media requests
• Support data analysis and the development of slide sets
• Develop and maintain appropriate collaborations and relationships with relevant professional societies.

Clinical Planning/Clinical Research/Trial Execution and Support

• Drive process of India Clinical Trial (CT) selection from the Global and Regional plan
• Input into the development of Global and Regional CT plans
• Implement, in consultation with the Clinical Operations lead, the Global / Regional CT plan with Quality Speed and Value
• Develop and implement a local CT plan. Participate in investigator interaction and site selection, start-ups, site issue resolution and Plan Do Review (PDR) meetings, trial initiation meetings along with MAPs wherever required

External Relations

• Identify and engage with Health Care Professionals (HCPs), Advocacy Groups, government and other professional bodies as determined by business needs
• Share and involve relevant HCPs compliantly in new developments / data surrounding the product
• Drive involvement of relevant HCPs at internal and external local, national and international meetings
• Drive appropriate involvement of relevant HCPs with publications and product communications

People Responsibilities

• Works closely with direct reports like Medical Affairs Professional (MAP) on performance management plans (objectives), development plans, and documentation of their expertise. Keeps these documents and plans up to date. Meets regularly with each direct report to coach, mentor, evaluate performance, evaluate training and development needs, and monitor career development goals. Maximizes each individual direct report's career potential, maximizing the value to the organization
• Actively participate in recruitment, diversity, and retention efforts, and hiring efforts as applicable
• Works closely with dotted line reports ie Medical Science Liaisons (MSLs) for enhancing their scientific knowledge on disease area and clinical trial data of the product, provide inputs for preparing field medical plans and its execution along with MSL Lead / Manager and MSLs. Participates in performance management discussions along with MSL Lead / Manager of the MSLs