Job Description

Provides specialist medical/scientific strategic and operational input for one or a cluster of countries within Western Europe & Canada into core medical affairs activities such as: healthcare professional/provider interactions (Payers, Patients, Prescribers, and Providers); generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities). Works closely with sales, marketing and commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical/marketing activities (promotional material generation/product launches) and market access.

Responsibilities

• In cooperation with affiliate / Area Medical teams, Marketing, RA, Clinical and other functional areas, provides leadership, oversight and support for assigned products/projects.
• Establishes and approves scientific methods for hypotheses, rational, design of affiliate/Area/Global protocols and their reports.
• Participation in design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for routine and ad hoc safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events (AE’s) and Serious Adverse Events (SAE’s) if assigned to AbbVie conduct on clinical studies.
• Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety (AE’s & SAE’s) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities. NB: All clinical research / development activities for products under development, and for post approval commitments such as regulatory agency mandated trials,
• or those intended to support product registration or to generate data for label inclusion remain the primary responsibility of TA development teams. Initiates medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy.
• Provide scientific/medical education to investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps a breast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource.
• Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions
• May act as medical/scientific leader for projects within an area or across several area
  Assists with the scientific review, development, approval, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
• May lead cross functional sub teams responsible for discrete projects within the therapeutic area (individual publications or study collaborations)
• Initiate research projects and drive them to completion, resulting in high quality publications. Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities