Joulé · 7 hours ago
Senior Manager, Compliance
Raritan, NJ
Contract
Remote
Mid, Senior Level
$140K/yr - $140K/yr
3+ years exp
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Responsibilities
Project management focused
Detail oriented
Multitask by overseeing multiple simultaneous projects/studies in different stages of development
Entry of projects/studies into system
Continuous tracking of project/study status
Continuous oversight of projects/studies through the process of contracting, obtaining legal review, obtaining other internal approvals, ensuring upload of correct documents into system, and then appropriately closing out the projects/studies ensuring all the appropriate documentation was obtained.
Ability to interact with personnel from multiple roles/levels and influence project/study compliance
Generation of periodic status reports/metrics
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
Qualification
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Required
Bachelors Degree
3-5 + years of Quality/Compliance/Training experience (Pharma/CRO)
strong experience managing and overseeing projects/studies in their Totality System
project management focused
detail oriented
multitask by overseeing multiple simultaneous projects/studies in different stages of development
Entry of projects/studies into system
continuous tracking of project/study status
continuous oversight of projects/studies through the process of contracting, obtaining legal review, obtaining other internal approvals, ensuring upload of correct documents into system, and then appropriately closing out the projects/studies ensuring all the appropriate documentation was obtained
Ability to interact with personnel from multiple roles/levels and influence project/study compliance
Generation of periodic status reports/metrics
EXCELLENT writing skills
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)
Assist in developing and overseeing the Advisory Board process
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
Ensure all GCSO Summit Curricula are up-to-date with current trainings to ensure both GxP and non-GxP compliance
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
Benefits
Exempt/Salaried - FTE Benefits
Company
Joulé
At Joulé, we believe our world is filled with possibilities – where character, integrity, and commitment drive our purpose.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase
