Medical Advisor, Nephrology

Department: Medical and Regulatory Affairs

Reports To: Senior Director, Medical Affairs, Nephrology

Summary of Purpose:

Support Medical Affairs activities for Nephrology portfolio products. Provide fair balanced, objective, scientific input and education about disease state, therapeutic landscape and Nephrology portfolio product(s). Continuously expand medical and scientific expertise through peer-to-peer interactions with key opinion leaders (KOLs), investigators and other healthcare providers to improve patient outcomes.

Medical Advisor Responsibilities:

• Provision of scientific and medical expertise for Nephrology portfolio products, beginning in late phase development and throughout the product lifecycle
• Provision of strategic scientific/medical input in the development of brand medical plans and overall brand plans, including during brand launches
• Support the development and execution of medical affairs plans for Nephrology portfolio brands throughout their lifecycle, including (but not limited to) late phase studies, Investigator sponsored trials, data analysis/interpretation, publications, and other medical projects
• Participation in conferences and scientific meetings to maintain knowledge base and keep up-to date awareness of research in the field
• Relationship building with KOLs, investigators, external consultants and vendors
• Provision of medical input and scientific reviews to the brand matrix, including Medical Information, Pharmacovigilance, Regulatory Affairs, Market Access, CHE and Commercial functions (including the review of promotional documents)
• Provision of medical expertise and scientific training and support across the Brand matrix
• Reporting Safety Information, Product Quality Complaint and Customer Feedback as per training on current procedures

MSL Responsibilities:

• Ensure appropriate dissemination of clinical information, knowledge and services in a timely, ethical and customer-focused manner
• Establish status as a knowledgeable and trustworthy medical and scientific resource for opinion leaders with expertise and knowledge of supported products(s), treatment trends, clinical trials and scientific research
• Keep abreast of the current literature, new and emerging research interests, trends, therapeutic issues and competitive landscape related to the relevant disease areas of focus
• Communicate current and emerging clinical research data to opinion leaders in response to unsolicited inquiries. Communicate Otsuka’s long-term project and product goals
• Identify medical experts to provide services as speakers, consultants, and investigators

Qualifications and Key Competencies:

• D., PhD, or PharmD with more than 5 years’ experience in pharmaceutical industry with experience in Clinical Research and with a Medical Affairs focus preferred (medical advisor role)
• Knowledge of clinical trial design, clinical studies operations, regulations, execution and familiarity with Biostatistics
• Proven knowledge and competencies in the Nephrology therapeutic area and demonstrated ability to comprehend complex scientific data and concepts
• Strong communication and presentation skills and ability to explain complex scientific data and concepts to a variety of audiences
• Sound knowledge of the Canadian Healthcare System, ICH guidelines, GCP and other ethical guidelines relevant to the pharmaceutical industry such as R&D guidelines and PAAB code
• Deep understanding of Canadian pharmaceutical safety reporting and surveillance
• Strong business acumen, including technology skills, business and market knowledge
• Ability to organize, prioritize, and work effectively in a constantly changing environment. Must be able to work independently and in groups in a collegial manner, including with cross functional teams and internal/external networks
• Excellent interpersonal skills (including ability to network), strong personal integrity, teamwork abilities (including the ability to serve as a role model for activities) and a customer focus are necessary
• Good leadership skills and Strategic thinking
• Knowledge of the business strategies and the business implications of scientific and medical plans and decisions
• Willingness to travel (20-30% travel time)