Regulatory affairs associate Offres d'emploi - Whitby, ON

Description

Key Responsibilities :

Lead the development, execution and coordination of the Medical Affairs plan of action (POA) for Liver Diseases.

Co-lead the launch and pre-launch activities for new therapies in Gilead Canada's liver portfolio, including viral hepatitis and auto-immune liver disease.

Focus on compliantly enhancing pan-Canadian liver disease care through non-promotional activities and education on liver disease awareness.Focus will be on developing appropriate programs, and data generation within the Liver Disease therapeutic area.

Develop and implement defined goals and objectives aligned with the Medical Affairs Plan of Action and other strategic initiatives

Effectively communicate the clinical data to support Gilead products for the treatment of liver disease.

Provide medical leadership to plan and execute Medical Affairs Advisory Programs and provide support as needed to cross-functional HCP advisory boards.

Develop effective working relationships as the medical expert in Liver Diseases with cross functional teams.

Strategic support of local Medical Affairs publication planning

Provide medical and scientific oversight to Liver disease publications and scientific presentations.

Establish strong working links with all relevant Gilead departments (e.g. EMEAC / FC HEOR, Market Access, Government Affairs, Regulatory Affairs, Stakeholder Relations, Marketing).

Generate and disseminate data to support use of Gilead products for the treatment of liver disease (including pipeline, as appropriate).

Support the development of local Phase 3b and 4 Investigator Sponsored Research (ISR).

Communicate Gilead’s commitment to scientific excellence in Liver Disease through research and balanced education.

Lead the medical and scientific review of local promotional materials for Liver Disease treatments.

Is responsible for adverse event reporting and management of drug safety and pharmacovigilance activities in compliance with local and global regulatory requirements and policies.

Knowledge, Experience & Skills :

M.Sc., M.D., PhD. or Pharm.D.

Strong medical / clinical / scientific background in Liver Diseases, Hepatitis, and / or Gastrointestinal / metabolic diseases is preferred.

3 - 5 years Pharma industry experience in Medical Affairs (including new product launches).

Extensive Canadian experience in Project Management and CME is required.

Experience in developing effective abstracts, manuscripts, posters and slides and presenting at scientific meetings.

Excellent written, verbal and interpersonal, relationship-building and negotiating communication skills.

Excellent analytical skills demonstrated ability to identify and understand complex issues and problems and identify and query key findings from study data and publications.

Must be able to utilize complex scientific resources for development of educational programs and presentations in a variety of different settings.

Excellent teamwork skills.

Organized; attention to detail and able to meet timelines in a fast-paced environment.

Ability to work on multiple projects simultaneously and effectively prioritize workload.

Must be able to work with a high level of autonomy and independence.

Must be fully cognizant and adhere to all regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities.

Bilingual candidates are preferred.

Position requires approximately 25% travel.

Gilead Core Values :

Integrity (Doing What's Right)

Teamwork (Working Together)

Excellence (Being Your Best)

Accountability (Taking Personal Responsibility)

Inclusion (Encouraging Diversity)

About Gilead :

Gilead Science. Inc, is research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life threatening diseases around the world. Gilead's therapeutic areas of focus include HIV / AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

For Current Gilead Employees and Contractors :

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