Senior Manager, RIM Training

Location
Tarrytown, New York, United States of America
Posted
Jul 04, 2021
Ref
25193BR
Discipline
Administration, Training
Required Education
Bachelors Degree
Position Type
Full time
Responsible for leading the RIM training team who provides training, continuous improvement and change management on Reg Ops processes, systems, and tools that support compliance with applicable Regulatory Agency regulations, guidelines, specifications (eg, FDA, EMA, ICH, etc), and internal policies and procedural documents.

Requires minimal guidance from direct manager.

Requires to function as a contributor as needed.

Provides support and backup to management as needed.

Will be responsible for supervising staff in addition to implementing employee development plans.
In this role, a typical day might include the following:
  • Responsible for Implementing training strategies to ensure effective utilization of Reg Ops capabilities.
  • Responsible for coordinating onboarding and training of Reg Ops-related processes, systems, and tools.
  • Responsible for providing training on drug development essentials, and updated Agency Regulations, guidance, and specifications.
  • Responsible for participating in Reg Ops-related system projects and developing new training materials as needed.
  • Responsible for developing collaborative projects with internal/external departments to address application training scenarios.
  • Responsible for applying a change management process and tools to create a strategy to support adoption of the changes required by a project or initiative.
  • Responsible for creating Reg Ops awareness by designing, developing, marketing and distributing Reg Ops-related communications.
  • Assist with conducting Reg Ops-related software/Web Application impact analyses and assessing change readiness.
  • Responsible for updates and maintenance of digital Regulatory Application training resources
  • Provides leadership and subject matter expertise on Reg Ops-related projects.
  • Communicates regulatory system enhancements and technical issues to key stakeholders.
  • Manage vendors who support Reg Ops-related training.
  • Assists with regulatory inspection activities.
  • Communicates the need for additional resources to management as needed.
This role might be for you if:
  • Requires strong knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
  • Requires strong knowledge of training and change management.
  • Knowledge of pharmaceutical drug and device development process.
  • Knowledge of scientific industry terminology and how to effectively use in training.
  • Ability to lead, manage, and/or contribute to multiple ongoing projects and improvement initiatives simultaneously
  • Change management experience required
  • Ability to engage and influence a variety of stakeholders at all organizational levels required
  • Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills.
  • Working knowledge of Reg Ops technology solutions (Veeva Vault preferred), eCTD and Non-eCTD publishing systems, submission validation and viewing tools, SharePoint Online, XML, Microsoft Office suite, and Adobe Acrobat are required. Working knowledge of technical writing is preferred.
  • Possess courage, energy and drive, strong operating skills, strong personal and interpersonal skills, strong critical thinking, and strong strategic skills.
  • Will be responsible for managing staff


Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.