The key priority areas include:
Thought Leader and CMH Specialists support (pre, peri, and post-launch support):
· Understand and anticipate the scientific information needs (payers, patients, health care providers) and actively address their questions in a timely fashion by leading data analyses and new clinical or health outcomes research efforts.
· Development and implementation of medical strategies to support brand commercialization activities by working closely with the global Medical Affairs and brand teams, Global Patient Outcomes/Real World Evidence, and global PRA, clinical management or personnel, and other cross-functional management during the development of the regional business plan.
Medical Affairs planning support:
· Leverage deep product/disease knowledge and educate the network of peers, so they are ready to support their launches.
· By offering scientific and creative input, contribute to the development, review, and approval of promotional materials for the brand team at the Alliances regional level.
Clinical Planning & Clinical Research/Trial Execution and Support:
· Represent the clinical needs of the country/region to the business unit medical leadership in the development of clinical strategies, development plans and study protocol design.
· Review and approve local informed consent documents and risk profiles to ensure appropriate communication of risk to study subjects.
· Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions).
Scientific Data Dissemination / Exchange, Training, and Education:
· Knowledge of and 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.
· Understand and actively address the unsolicited scientific information needs of external health care professionals according to guidelines above.
· Support the planning of symposia, advisory board meetings, and/or the facilitation of other meetings with health care professionals at Alliances level.
· Support medical information associates in preparation and review of medical letters and other medical information materials.
· Establish and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community on a local, national, regional, and possibly international basis.
Regulatory Support Activities:
· Participate in development and review of local labelling and labelling modifications in collaboration with global Development, brand teams, regulatory, and legal. Demonstrate deep knowledge of local label.
· Provide medical expertise to regulatory scientists.
· Participate in advisory committees.