• Develops and implements Medical and Scientific Affairs Plans, including study and publication plans, for key products in the portfolio, in alignment with the Project Team and Lifecycle Product and Marketing Plan.
• Develops and executes study protocols for Roche Sponsored studies, in collaboration with key internal and external stakeholders, to produce high quality data to support the goals of the Medical and Scientific Affairs Plan.
• Evaluates Investigator Initiated Studies (IIS), participates in Clinical Trials Review Process and is accountable for activities related to approved IISs.
• Authors and assists with scientific publications, including abstracts, posters, manuscripts and whitepapers. Generates medical and scientific information materials.
• Plans, develops, and generates content and delivers internal and external scientific and educational programs.
• Establishes and maintains ongoing long-term collaborative peer-to-peer relationships with key thought leaders and manages Global Key Opinion Leader activities, including Advisory Boards; aligns with IBT and Regions to ensure transparency regarding KOL activities.
• Contributes to, reviews and approves medical/scientific communications including marketing materials and participate in Promotional and Scientific Content Approval Processes.
• Responds to unsolicited requests for information from healthcare professionals that are received either directly or indirectly through Regional organizations, in accordance with all compliance regulations and policies.
• Serves as liaison for Medical and Scientific Affairs activities across diagnostics BA and Pharma Medical and Scientific partners for collaborative projects.
• Supports Regional Scientific Affairs and Customer Service Operations at high level of escalation to assist with customer interactions and trouble shooting.
• Maintains clinical, scientific and technical expertise in specific therapeutic areas; reviews scientific journals; attend scientific and key technical meetings; participate in internal training programs. Keeps abreast of the current literature, collects and communicates medical and scientific insights and intelligence relevant to Lifecycle and product portfolio.
• Advanced Clinical/Science Degree (e.g. MD, PhD
• Minimum of 3 years clinical research experience, including design, protocol development and conduct of trials.
• Previous medical/scientific affairs experience in clinical/life science and/or diagnostic oriented markets advantageous.
• Experience working in a matrix organizational structure.
• Professional experience with clinical research and trial design, writing protocols and publications.
Knowledge, Skills, and Abilities:
• Understands the US Medical Testing environment (e.g. FDA, CAP, CLIA Guidelines).
• Excellent product and related disease area scientific knowledge.
• Ability to operate effectively within a heavily matrixed organizational structure.
• Excellent verbal and written communication and presentation skills.
• Excellent people skills.
• Excellent organizational skills.
• Strong process orientation.
• Ability to work autonomously and as part of a cross-functional team.
• Functions with excellent judgment, high integrity and in compliance with all laws, regulations and policies.
• HQ based position with international/domestic travel requirement between 20-30%.
Roche is an equal opportunity employer.Medical Affairs, Medical Affairs > Medical Information/Scientific Affairs