Senior Manager, Compliance and Training

7 days ago


Raritan NJ United States Joulé Full time

Title: Senior Manager, Compliance and Training

Check out the role overview below If you are confident you have got the right skills and experience, apply today.
Location: Remote but local to NJ, NY, PA or CT
Type: Embedded
Salary: 130-140K
Start Date: ASAP

Leading Pharmaceutical Company located in NJ is hiring a Senior Manager, Compliance w/ 3+ years industry experience. If you want to be a part of this groundbreaking work, please apply

Perform the following compliance review and oversight activities:

Assist in developing and overseeing the global oversight of Additional Risk Minimization Activities (ARMA)/Core Additional Risk Minimization Activities (CARMA) process for Global Medical Affairs (MAF). This will include development of a procedural document, development of related training, oversight communications, and routine verification of process compliance.
Assist in developing and overseeing the Advisory Board process, including development of training materials, communications to this community, oversight of the process and routing compliance monitoring of Totality system for compliance.

Provide training and guidance on Totality system to external vendor personnel.

Maintain procedural documents in the TruVault Document Management System.

Assess new hire training for new Global Commercial Strategy Organization (GCSO) employees and follow Summit procedures while working with the Summit support team to request training and ensure training is correctly setup.

Ensure all GCSO Summit Curricula are up-to-date with current trainings to ensure both GxP and non-GxP compliance while partnering with the Summit Support team to make changes to GCSO curricula.

Partner with GCSO teams and the Summit support team to setup GCSO specific learning objects in Summit

Assess cross-pharma SOPs additions and changes for updates to any applicable GCSO curricula.

Partner with GCSO leaders to assess and create new functional team training curricula, as needed.

Generate overview of each training curricula for biennial review by GCSO business owner

Facilitate biennial review and subsequent revisions to training curricula.

Facilitate assignment of training curricula to new employees

Facilitate development of training metrics

Requirements:
Bachelors Degree
3-5 + years of Quality/Compliance/Training experience (Pharma/CRO)



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