Manager- Medical and Scientific Affairs

Manager – Medical and Scientific Affairs

Xediton is a specialty pharmaceutical company focused on meeting the needs of patients, physicians and partners. We are committed to developing, partnering and making available new and established medicines to promote the health of Canadians. Our office is located in Oakville, Ontario.

For more information, visit

our website at  or email your resume and cover letter to

XEDITON is currently seeking energetic, self‑motivated professionals with strong communication skills for the role of Manager – Medical and Scientific Affairs.

You will be the subject‑matter expert responsible for providing medical leadership to the organization for our in‑line products and Business Development efforts. Regulatory and PV report into this role.

This is an office‑based role and requires a small amount of national and international travel, including internal meetings and external scientific conferences.

• Lead the development of the Strategic Plan and Plan of Action for Medical Affairs for both new and existing products by developing and implementing a local, integrated medical strategy and KOL engagement plans.
• Establish and maintain strong networks and relationships with the medical community locally and internationally, including academic societies, KOLs and researchers.
• Plan and conduct Advisory Boards to gain insights.
• Develop and conduct medical education and communication activities, congress presentations, publications and congress sponsor ships; and provide training to HCPs and other experts.
• Provide responses to healthcare professionals requesting medical/scientific information on company’s products.
• Provide training for the business, Commercial and other internal colleagues on all product and medical‑related matters, including ongoing disease‑state and product‑specific training to a cross‑functional team as needed.
• Work collaboratively with internal colleagues in the development and review of patient materials, marketing materials, posters, abstracts, literature, clinical trials, study protocols and scientific content for HCPs and patient education.
• Be responsible for the approval of all internal and external facing scientific content (e.g., regulatory, market access, and commercial), ensuring accuracy and integrity of scientific information and data presented.
• Lead the preparation of the HTA clinical sections of the reimbursement dossier.
• Act as a Medical Advisor to the Business Development department’s Product Evaluations, Assessments and Due Diligence efforts and provide medical insights for future products.
• Support Business Development efforts by providing scientific assessment of pipeline products to better understand synergies and alignment between pipeline and future products.
• Assist in the development of procedures and processes to ensure compliance with the Food and Drug Act and Regulations and ensure that all company activities are GMP compliant.
• Provide the clinical strategy for Regulatory NDS/sNDS and all other Health Canada submissions.
• Be responsible for managing the organization’s Regulatory and Quality Management systems and processes.
• Ensure appropriate pharmacovigilance processes are in place for pipeline and marketed products.
• Manage the identification, collection and reporting of any adverse events and/or other reportable events to Health Canada.

• Advanced University Degree in a Life Sciences/Science‑Based Program (PhD, MD, Pharm
  
  D).
• At least 8 years of hands‑on medical experience in a pharmaceutical environment with progressive leadership experience.
• Good understanding of relevant regulations and processes (e.g., GCP, PV, Industry Codes & Regulations).
• Good understanding of the development of pharmaceutical drug assets and evidence generation.
• Clinical/therapeutic knowledge of different disease areas and an understanding of biosimilars, vaccines and biotechnology.
• Developed and proven experience in principles and techniques of statistical analysis, data analysis and interpretation.
• Ability to understand scientific concepts and study results, synthesize and communicate those results to experts and…