• Responsible for growing and sustaining the MedTech market for Vault applications, including Submissions, Registrations, Submission Publishing, and others as determined in the future • Provide thought leadership and sales support to teams in driving new opportunities in the Regulatory space • Provide business and technology guidance to the Product team in support of new or enhanced features and functionality in defined applications • Develop strategy and messaging for customer adoption of new features and functionality for a new and existing customer base • Coordinate resources across the customer lifecycle from sales to delivery and beyond • Present at industry conferences, lead webinars, and author articles for industry publications

• Assessment of change controls • Preparation of submission strategies • Identifying Japan regulatory requirements • Evaluating supporting documentation for acceptability and potential risks • Authoring high-quality variation packages for PCA and minor change notifications • Authoring responses to RTQs based on guidance • Operational support for GMP inspection packages • Liaison with clients and external partners for change management

• Act as the General Marketing Supervisor (GMS), overseeing Quality Assurance and Pharmacovigilance functions • Manage both pre- and post-approval GMS responsibilities with effectiveness and accountability • Develop and implement regulatory strategies for assigned pharmaceutical products • Lead the preparation and submission of regulatory documentation, including Module 1 and Application Forms for Marketing (AFM)

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description NSS has an immediate need for a Compliance Consultant with DCAA Audit experience. 2+ month contract. Start ASAP. - MUST BE US CITIZEN - 5+ years experience in audit or financial compliance in a Govcon environment - Experience writing GAAP-compliant, FAR-allowable, and DCAA-defensible Accounting policies & procedures including key controls - Experience identifying gaps between policy and practice - Experience supporting audits and liaising directly with auditors: - DCAA audits (incurred cost, accounting system, billing system, floor checks) - External financial statement audits - Strong working knowledge of: - FAR Part 31 - CAS (418/410/401/402, as applicable) - ASC 606 in a Govcon environment - Hands-on experience with Unanet or similar ERP Qualifications - MUST BE US CITIZEN Requirements - 5+ years experience in audit or financial compliance in a Govcon environment - Experience writing GAAP-compliant, FAR-allowable, and DCAA-defensible Accounting policies & procedures including key controls - Experience identifying gaps between policy and practice - Experience supporting audits and liaising directly with auditors - Strong working knowledge of FAR Part 31, CAS (418/410/401/402, as applicable), and ASC 606 in a Govcon environment - Hands-on experience with Unanet or similar ERP Company Description