Manager- Medical and Scientific Affairs

Xediton is a specialty pharmaceutical company with a focus 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. We are located in Oakville, Ontario.
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Manager
- Medical and Scientific Affairs  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.
Responsibilities   Leads 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.
Establishes and maintains strong networks and relationships with the medical community locally and internationally, including academic societies, KOLs and researchers.
Plans and conducts Advisory Boards to gain insights.
Develops and conducts medical education and communication activities, congress presentations, publications and congress sponsor ships; and provides training to HCPs and other experts.
Provides responses to healthcare professionals requesting medical/scientific information on company’s products.
Provides training for the business, Commercial and other internal colleagues on all product and medical‑related matters and ongoing disease‑state and product‑specific training to a cross‑functional team as needed.
Works 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.
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.
Leads in the preparation of the HTA clinical sections of the reimbursement dossier.
Acts as a Medical Advisor to the Business Development department’s Product Evaluations, Assessments and Due Diligence efforts and provides medical insights for future products.
Supports the Business Development efforts by providing scientific assessment of pipeline products to better understand synergies and alignment between pipeline and future products.
Assists 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.
Provides the clinical strategy for Regulatory NDS/sNDS and all other Health Canada submissions.
Responsible for managing the organizations Regulatory and Quality Management systems and processes.
Ensures appropriate pharmacovigilance processes are in place for pipeline and marketed products.
Manages the identification, collection and reporting of any Adverse Events and/or other reportable events to Health Canada.

Skills & Qualifications   Advanced University Degree in a Life Sciences/Science Based Program (PhD, MD, Pharm

D).
Must have at least 8 years hands‑on Medical experience in a pharmaceutical environment with progressive leadership experience.
A good understanding of relevant regulations and processes (eg. GCP, PV, Industry Codes & Regulations).
A 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 non‑experts.
Ability to think medically and strategically about the short‑ and long‑term impacts within our health care…