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Pay Range: $48.20 - $65.33/hr
Remote Role (US Only)
12 Month Contract
This individual will be responsible for supporting document management of Clinical Trial Applications (CTA) and related health authority submissions through collaborations with internal and external key stakeholders: including Chemistry Manufacturing and Controls (CMC) team members and Contract Research Organizations (CROs), as well as corporate and collaborative partners, Regulatory Liaisons, vendor management and other cross-functional team members.
In this role, a typical day might include:
Responsible for tracking Clinical Trial Application (CTA) submission deliverables
Downloading of CTA deliverables from numerous CRO web-based systems and communicating updates to key stakeholders in a timely fashion. Updating will also include numerous tracking platforms to help obtain metrics and communicate study updates to other teams
Collect, upload and manage Regulatory Agency communications, in all formats (e.g. emails, Phone conversations, hard copy letters, etc.) within the Veeva Vault RIM document repository
Brief review of regulatory packages and tracking of any issues or gaps in data collection
Manage CTA regulatory submission/document transfers between Regeneron and CROs. This can include scheduling meetings (Microsoft Teams) and applicable follow-up communication for deliverables
Responsible for supporting the tracking of Reference Safety Information (RSI) approvals by global health authorities, and tracking for Global Pharmacovigilance (PV) Planning Team. Additional responsibilities may include other documentation management needs for U.S. and other health authority submission activities.
Collaborates with the functional area team and key stakeholders
Communicates key RSPM related information to consumers, collects feedback, and takes action
Identifies and communicates regulatory system enhancement needs or technical issues
This role might be for you if can/have:
Knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, eCTD, IDMP, UDI, etc).
Knowledge and practical experience in managing global Clinical Trial Applications (e.g. IMPD) preferred
Knowledge of pharmaceutical drug and device development process
Experience in Regulatory Affairs/Operations/information preferred
Knowledge and practical experience with RIM technologies preferred
Knowledge of scientific industry terminology
Knowledge of categorization and classifying information
Ability to manage, and/or contribute to multiple ongoing projects simultaneously
Works well in a team-environment and can provide feedback for process or project needs
Excellent written and oral communication skills. Self-motivated with energy and drive to work both independently and in a team environment. Can think critically and can be flexible dependent on project needs. Strong organizational skills and ability to multi-task
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
Possess courage, energy and drive, strong operating skills, strong personal and interpersonal skills, strong critical thinking, and strong strategic skills
To be considered for this opportunity, you must have at minimum a Bachelors Degree with 4+ years of relevant experience.
This is a contract position at Regeneron with Magnit Global being the Employer.
To do our best work we need different viewpoints. Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills. We strive to ensure that we maintain a positive and enriching work environment for all.
W2 only, no third party solicitation
