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Medical Affairs Operations Lead

2 months ago

Canada, CA Astellas Pharma Full time

Medical Affairs Operations Lead - Canada, a Hybrid role Markham, Ontario

(relocation assistance is not available)


Do you have excellent PM skills, Medical Affairs experience? Apply today.

Astellas Pharma Canada is currently searching for a Medical Affairs Operations Lead reporting to the Affiliate Head of Medical Affairs - Canada. This is a head office position located in Markham, Ontario.



The Medical Affairs Operations Lead leads the operational efforts to drive annual and longer-term medical planning, and execution of Medical Affairs (MA) activities and deliverables. Role strongly contributes to the establishment of an operational framework/ infrastructure to ensure adequate oversight of the execution of MA activities including tactical planning, Grants, Investigator Sponsored Research. In addition, this role provides both communication tools and management tools that meet the needs of the MA function and the stakeholders. This role ensures efficient collaboration between Regional and the Affiliate Medical Affairs.


Essential Job Duties- Medical Operations Leadership

  • Determine the operational plan for the execution of the affiliate annual plan to facilitate that deliverables and objectives are met, according to timelines, budget and quality standards.
  • Operating within the MA Governance create a local framework for decision making and infrastructure to monitor execution status i.e., sets-up a process for monitoring progress and organizes how that is implemented locally (what/ how, who are the local decision makers for change, when (timelines and touch points) and appropriate communication channels).
  • Operational and strategic contributor to affiliate MA organization and MA leadership.
  • Identify risk to the planned execution of MA activities and escalate to MA leadership, where necessary. Collaborate with medical teams to develop risk mitigation plans and establish corrective measures.
  • Provide subject matter expertise and advice to affiliate MA teams on Governance and Processes relating to execution of MA activities.
  • Prepare and present project updates, as required.
  • Contribute to the execution and delivery of special projects or initiatives as required, i.e., process improvement and project taskforces.


Budget Management

  • Support affiliate medical teams in managing budget, contract requirements for MA activities.
  • Coordinates affiliate MA budget and (re)-forecasts process, facilitates an accurate submission is made. (May be in collaboration with regional MA Finance Team.)
  • Connect the operations metrics to the financial metrics to ensure consistency.
  • Supports the on time raising of Purchase Orders with appropriate milestone deliverables and invoicing.


Medical Planning

  • Lead affiliate MA planning, coordination of key MA events/ Core Medical Planning (CMP).
  • Provides subject matter expertise on technical aspects relating to CMP process i.e., budget and tactic category definitions, submission tool requirements, global and regional timelines.


Metrics & Reporting

  • Organize meaningful metrics that supports local business decision making and reporting.
  • Collaborate with affiliate MA teams to ensure accurate, timely data completion, maintenance of data within repositories i.e., CMP Progress Tracker, AERO, PubStrat, finance systems.
  • Collaborate with stakeholders to ensure maintenance of non-CMP tactic metrics i.e. number of zinc job bags.
  • Collaborate with affiliate MA teams to develop content and metrics for monthly reporting requirements.
  • Analyze and interpret metrics in order to advise affiliate MA Leadership on operational issues.
  • Provide ad hoc metrics for within the MA function or towards external stakeholders, as required.


Investigator Sponsored Research

  • Oversight of ISR execution via the AERO portal and ensure metrics are updated according to contractual milestones.
  • Act as SME on the operating model for the set-up, governance and execution of ISR.
  • Management of affiliate MA Grant budget.
  • Supports External Funding submissions in accordance with Astellas Processes.


Process & Training

  • Gain insights on short and long-term affiliate MA training needs.
  • Develop, lead and ensure consistency in the medical onboarding experience for newly hired MA members, in alignment with the regional led on-boarding program.
  • Design or give input on new processes, the reduction of processes or simplifying processes to respond to changes in the internal or external environment. Assist in identifying areas of improvement in process/policy, develops recommendations/plans, and lead initiatives, as required, locally.
  • Support and executes training, as required, locally.
  • Systems knowledge and capabilities in all tools relevant for use by MA.

Matrix Working

  • Connect affiliate and regional Medical Affairs Operations function in order to ensure alignment and efficient ways of working


Required Qualifications

  • BSC or MSc
  • Minimum 5 years’ experience in the pharmaceutical industry in a science/medical based function, with a minimum 3 years’ Medical Affairs experience
  • Strong knowledge of governance processes and quality standards, local laws and guidelines
  • Analytical, problem-solving skills, project management, planning, prioritization and organization skills with excellent interpersonal skills, communication, writing & presentation skills
  • Previous budget management experience
  • Matrix navigation expertise
  • Working knowledge of Astellas key products/disease states across all TAs
  • Fluency in local language and proficient in written and spoken business English


Additional Information

Astellas Pharma Canada welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the hiring process.