Clinical Research Scientist - Medical Affairs


Primary Responsibilities:

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.

Business/ customer support (pre and post launch support)

• Understand and anticipate the scientific information needs of all local/regional customers (payers, patients, health care providers)
• Contribute to the development of medical strategies to support brand commercialization activities.
• Contribute as a scientific and clinical expert to activities and deliverables of the PRA organization, in particular giving clinical input and insight to develop payer partnership programs and defend the product value.
• Support business-to-business and business-to-government activities as medical expert.
• By offering scientific and creative input, contribute to the development, review, and approval of promotional materials for the brand team.
• Support training of sales representatives, and other medical representatives.
• Take a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his/her medical knowledge. Become patient advocate, as well as a medical expert.
• Provide medical insight and training to patient support programs (for example, Diabetes Nurse Educators Service).

• Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines.
• 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 and/or the facilitation of other meetings with health care professionals.
• Support training of local medical personnel, including medical and/or outcome liaisons and health outcomes staff.
• Prepare or review scientific information in response to customer questions or media requests.
• Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts).
• Support the design of customer research as medical expert.
• Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events).
• Participate in data analyses, development of scientific data dissemination, and preparation of final reports and publications.
• Participate in reporting of clinical trial data in Clinical Trial Registry activities.

• Communicate and collaborate with Director-Medical and Business Unit Team Physician/Regional Medical Leader as needed to ensure life cycle plans for drugs in development address customer needs or communicate and collaborate such needs as delegated by Director-Medical and Business Unit Team Physician/Regional Medical Leader, as needed, to global Medical Affairs and Development teams, Global Patient Outcomes/Real World Evidence, PRA, Therapeutic Area Program Phase, and Early Phase /EPM/Translational Medicine teams.
• Communicate local/regional research needs and collaborate with other regions and the global Development and Medical Affairs teams, Global Patient Outcomes/Real World Evidence, and PRA teams to ensure Phase 3, 3b, and 4 (and Phase I and II where applicable) clinical programs meet the needs of local/regional customers (for example, through global medical planning processes).
• 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).
• Collaborate with clinical research staff, regional clinical operations staff, statisticians, global patient outcomes, research scientists and selected investigators in the development of protocols and data collection requirements.
• Participate in investigator identification and selection, in conjunction with clinical teams.
• Ensure that the clinical operations team has documented the completion of administrative requirements for study initiation and conduct (i.e., ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.
• Assist in the planning process and participate in study start-up meetings and other activities to provide the appropriate scientific training and information to investigators and site personnel.
• Serve as resource to clinical research site monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
• Review lIT proposals and publications, as requested
• Contribute to global alignment of Phase 3b/4 clinical studies (and Phase I and II studies where applicable) planned by country(ies) or global Development and Medical Affairs teams.
• Understand and actively address the scientific information needs of all investigators and personnel.
• Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures.

• Participate in development and review of local labeling and labeling modifications in collaboration with global Development, brand teams, regulatory, and legal. Demonstrate deep knowledge of local label. Provide medical expertise to regulatory scientists.
• Support I assist in the preparation of regulatory reports, preparation for regulatory agency advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from an affiliate/country perspective.
• Participate in advisory committees.
• Participate in risk management planning along with global Development team(s), business unit, local area, and Global Patient Safety (GPS).

• 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.
• 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 behaviors.
• 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)
• Fluent in English, verbal and written communication
• Stamp 4 Visa/ EU Citizenship

• 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