Title: Senior Manager, Compliance
Location: Can be fully remote - ideally located in NJ/NY/PA/CT (NE)
Exempt/Salaried - FTE Benefits
Target Comp: $140,000
Per the MGR- she wants someone that has strong experience managing and overseeing projects/studies in their Totality System which a tool used to manage the healthcare compliance responsibilities of their Suppliers.
The role is related to managing the process of overseeing projects/studies in the Totality System. It will require the following skills and abilities: 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
They need to also have the following:
* EXCELLENT writing skills. They will be drafting/sending out large communications, supporting clinical teams and medical teams on communications. The Resource must be able to review SOW's and have a good understanding of their purpose. .
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)
System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.