Primary Responsibilities:

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.


The primary responsibility of the Business Unit- Medical Affairs CRS is to provide expert scientific and clinical support to all aspects of the local business, to ultimately enhance the customers' experience in interacting with the company. This includes local marketed product support (participate in the development of the "patient journey" and the strategic plan for the compound), medical support for regulatory affairs and interactions with government agencies (medical support for New and Supplemental New Drug Submissions and participating and presenting at meetings with government regulatory agencies), medical support for PRA (providing medical guidance on the PRA plan and interacting with government PRA agencies as needed), and leading in local scientific data dissemination (leading and presenting at conferences, advisory boards, etc., and overseeing the development of the scientific content of educational programs). These responsibilities are generally related to late-phase and marketed compounds, but can also include early phase trials (for example, phase I and II trials). The CRS is responsible for collaborating with the global teams in the planning, startup and conduct of phase 3b/4 studies (and phase I and II studies where applicable), as well as non-clinical trial solutions/activities that are conducted in affiliates/countries as described in the clinical plan. In addition, the CRS, if assigned by the Director-Medical and/or Business Unit Team Physician/Regional Medical Leader, is responsible for support of global Development studies conducted in affiliates/countries. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as all other duties as assigned.

Scientific / Technical Expertise and continued development

• Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product, both near term (1-2 years) and longer-term (3-5 years).
• Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the product.
• Responsible for the scientific training of the clinical study team.
• Acts as scientific consultant and protocol expert for clinical study team members and others in medical.
• Explore and take advantage of opportunities for extramural scientific experiences.
• Attend, contribute and participate in medical congresses/scientific symposia.

• Support the business unit management team, including medical leadership in preparation and administration of the local or business unit medical budget.
• Actively set and meet individual professional development goals and contribute to the development of others by being an active source of coaching and feedback to co-workers, and direct reports as applicable.
• Collaborate proactively and productively with all alliance, business, and vendor partners.
• Participates in active coaching by providing timely and constructive feedback to co-workers, others on the clinical medical team, in the spirit of development, increased team effectiveness and cohesiveness.
• As applicable, works closely with direct reports 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 and hiring efforts as applicable.
• Participate in committees, Six Sigma initiatives and task forces as requested by business unit/corporate management.
• Model the leadership behaviours.
• Be an ambassador of both patients and the company Brand.

• An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) and one of following
• 3-5 years of clinical experience or 3-5 years of pharmaceutical experience (2 of which is in clinical development)

• Have a BS or Masters degree in health/medical/scientific or related field and 7-10 years of pharmaceutical experience that is directly related to at least one of the following

• Clear evidence and documentation of candidate's direct role and contribution to medical content. This should include evidence of candidate as medical content owner (oversight of content development-creator/creation, reviewer, and approver. Medical content = medical, scientific or clinical information)
• Candidate's selection for CRS role must be endorsed by the BU Med affairs/development VP or equivalent area Senior leadership
• Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills
• Demonstrated strong communication, interpersonal, teamwork, organizational and negotiation skills
• Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
• Ability to engage in domestic and international travel to the degree appropriate to support the business of the team.
• Fluent in English, verbal and written communication

• Therapeutic area directors, managers, or project managers
• Product directors, managers, and associates of the brand
• Clinical research staff
• Statisticians
• Scientific communication associates
• Medical information associates
• Medical liaisons
• Global patient outcomes research consultants/research scientists and health outcomes liaisons
• Regulatory directors, scientists, and associates
• Sales representatives
• Legal counsel
• Therapeutic area physicians, global brand physicians, early phase physicians, clinical research scientists, and Regional Medical Leader, Directors-Medical.
• Corporate or regional patient safety physician(s)

• Scientific and clinical experts, thought leaders
• Company clinical investigators
• Practicing physicians/prescribers
• Regulatory agency personnel
• Professional association staff and leaders
• Disease advocates and lay organizations focused on relevant health issues
• Formulary representatives (private and government)