- Coordinate and interface with related Company functions and processes (e.g. Document Services, Business Learning Lead Network, etc.) to ensure GRC and Medical Affairs remains informed and ahead of changing business practices.
- Support the written standard strategy, ensuring Medical provides effective guidance that brings understanding and clarity to the work we do across Medical.
- Oversee and manage Medical written standard guidance to guarantee clearly identified process owners, control requirements documented at the right level, and elimination of unneeded or repetitive guidance.
- Oversee and support process owners in the development and maintenance of Medical written standards. Track and report ongoing project progress on a quarterly basis to leadership.
- Create awareness and buy-in at all functions and levels of Medical regarding knowledge management concepts, best practices, and strategic relevance.
- Identify, through close coordination with process owners, R&D and Training Services, individuals within Medical required to participate in various trainings.
- Assist in the implementation and management of tools to track and report key written standards and training metrics.
- Lead the development of metrics and visual representations of key insights, learnings and opportunities for improvement under the remit of GRC (i.e. written guidance cadence, deviations, audit/inspection learnings, training compliance and/or insights etc.).
- Coordinate systems for Medical that support access to and management of written standards (e.g. document management systems) and training (e.g. Alexion University, Cornerstone)
- Manage and optimize Medical's training matrix to ensure training compliance and to help close training gaps across Medical.
- Coach and support functions within Medical on best practices for creating and assigning training.
- Represent Medical in the Business Learning Lead Network.
- Support Medical teams with audit related requests as needed.
- Communicate and influence at all levels of the organization.
- Oversee and manage the Worldwide Medical Onboarding Process for new hires in Worldwide medical.
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
- 4+ years of industry experience required.
- Experience in document management
- Experience in learning management
- Excellent writing/communication skills, including data visualization.
- Experience with IT systems such as document management systems and learning management systems.
- Familiarity with Medical Affairs
- MBA
- Project Management certificate
- Experience with Corporate Compliance, Internal Audit and/or Quality
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Written Standard and Training Lead for Medical Affairs - Mississauga, Canada - AstraZeneca GmbH
Description
Written Standard and Training Lead for Medical Affairs
Location:
Mississauga
Global Level:
E
Job Code:
Reports To:
Neely O'Donnell – Director, Governance, Risk and Control for Global Medical Affairs
Date:
1/12/2024
This is what you will do:
The Lead for Written Standards and Training for Medical Affairs will be responsible for providing strategic development and execution of Medical's global knowledge management program within the scope of, and reporting to, Governance, Risk and Control (GRC). The knowledge management program will be strategically designed to ensure Medical personnel: have the right guidance at the right level; are proactively informed and trained; and that this knowledge is easily and readily accessible. The knowledge management responsibilities will also include translating risk and continuous improvement information into clear visuals or communication for Medical Affairs. The role is responsible for managing and continuously improving the Medical Affairs Written Standards Framework that ensures: written guidance reflects that activities of Medical Affairs; written guidance is clear, consistent, properly scoped and clearly identifies requirements, ownership and accountability; technology and tools support socialization and access, reports and robust feedback loop; and audit ready at all times with excelled results.
This role will also oversee the Global Medical Affairs Onboarding Program, ensuring that new hires are brought up to speed and provided appropriate Global Medical Affairs guidance and context as quickly as possible.
Responsibilities will include:
You will need to have:
This is a vital and visible role, with cross-functional impact across Medical worldwide and other functions within the Company. This role requires strong collaborative skills, knowledge of biopharma industry standards and practices and experience in project management. Candidates also must possess the ability to generate enthusiasm and followers, the ability to quickly gain trust and respect of peers and senior leadership, and a track record of successfully driving results through strong partnership with other functions and geographies.
Qualifications and Education:
We would prefer for you to have:
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Written Standard and Training Lead for Medical Affairs professionals in Mississauga
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Ohan Dsouza
Pharmacovigilance Expert | Safety Risk Management