Lead regulatory compliance projects from initiation through completion.
Interpret new and evolving regulations and translate them into actionable project plans.
Oversee regulatory audits, assessments, and remediation activities.
SGS is the global leader in inspection, verification, testing and certification services. With over 97,000 employees in 130 countries, they provide services to almost every industry assuring quality and safety of products and services, fostering innovation and welcoming new ideas.
Providing strategy based on regulatory requirements.
Completing regulatory and PV deliverables based on established plan.
Acting as Local Contact Person for Pharmacovigilance for designated country.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They provide first class support to their small to large pharmaceutical and biotechnology partners and value employee experience, well-being and mental health.
Design and/or enhance targeted and annual risk assessments.
Construct specific and effective auditing and monitoring workplans based on risks identified.
Analyze compliance outcomes and ensure detected issues are referred for remediation.
SmithRx is a rapidly growing, venture-backed Health-Tech company aiming to disrupt the expensive and inefficient Pharmacy Benefit Management (PBM) sector. With hundreds of thousands of members onboarded, they foster a mission-driven and collaborative culture, dedicated to transforming the U.S. healthcare system.
Research compliance program benchmarks and requirements.
Write/maintain compliance policies and program descriptions.
Assist compliance vendor oversight activities.
SmithRx is a rapidly growing, venture-backed Health-Tech company aiming to disrupt the PBM sector. They have a mission-driven and collaborative culture that inspires employees to transform the U.S. healthcare system.
Act as Local Contact Person for Pharmacovigilance for the designated country.
Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables.
Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They provide first class support to their small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field.
Serve as the enterprise Inspection Readiness Leader by defining strategy, policies, standards, governance frameworks, roles, responsibilities, escalation pathways, and operating models across all ARI sites and functions.
Design, implement, and sustain a standardized enterprise inspection readiness program, including lifecycle models for pre-inspection, active inspection, and post-inspection phases.
Provide enterprise-level oversight of inspection readiness posture, assess site readiness maturity using risk-based criteria and inspection indicators, and identify systemic inspection risks requiring enterprise remediation.
American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer, developing, manufacturing, and supplying high-quality generic and branded injectables. They have locations in New York, Ohio, and California and sales territories nationwide and have been in business for over 50 years.
Define a product vision supporting pharmaceutical IT solutions
Prioritize the backlog based on value and compliance
Connect IT teams with pharmaceutical stakeholders
Software Mind develops solutions that make an impact for companies around the globe. Building cross-functional engineering teams that take ownership and crave more means they’re always on the lookout for talented people who bring passion and creativity to every project.
Perform periodic reviews of business activities as mandated by the Sezzle Compliance Management System and Compliance Monitoring Program
Perform compliance control testing, transactional reviews, and monitoring activities in alignment with the established testing plan
Escalate significant compliance issues to management and provide actionable insights
Sezzle is financially empowering the next generation, revolutionizing the shopping experience beyond payments. They blend cutting-edge tech with seamless, interest-free installment plans, driving real impact on merchant sales. The team is innovative and dynamic.
Create and maintain detailed integrated project plans.
Partner with cross-functional teams to drive alignment.
Identify and manage project risks and mitigation strategies.
Jobgether uses an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company.
Manage compliant works council engagements across Germany, the Netherlands, and France.
Prepare meeting agendas and information packages for works council consultations.
Advise managers on works council requirements and procedural best practices.
GitLab provides an intelligent platform for DevSecOps, enabling organizations to increase developer productivity, improve operational efficiency, and reduce security and compliance risk. With over 50 million registered users, they foster a high-performance culture driven by values and knowledge exchange.
Lead and coordinate regulatory projects from initiation through completion.
Schedule and facilitate project meetings to ensure progress and alignment with all stakeholders.
Develop and manage project plans using project management tools.
Navitus is an alternative to traditional pharmacy benefit manager (PBM) models. They are committed to removing cost from the drug supply chain to make medications more affordable. At Navitus, team members work in an environment that celebrates diversity, fosters creativity and encourages growth.
Provide regulatory compliance risk assessment and consultation.
Assist financial services clients in strengthening their compliance management systems.
Conduct regulatory compliance testing for federal consumer compliance regulations.
Wipfli provides accounting and consulting services. Their people are the core of their business, and they focus on relationships while encouraging individuals to follow their own path.
Work with internal and external teams to ensure pharmacies meet accreditation requirements.
Assist with staff training and process implementation related to meeting accreditation standards.
Prepare reports and maintain records, and participate in internal/external meetings.
VytlOne (formerly Maxor National Pharmacy Services) is a leading, independent pharmacy solutions platform that improves prescription drug affordability and outcomes. With a workforce of 1,600+ and almost a century of pharmacy experience, they offer the stability of a Fortune 500 company and the energy and innovation of a startup.
Lead all phases of study management, including Planning and Setup, Monitoring, and Closeout.
Gather customer requirements and translate them into clear instructions for internal teams.
Identify study risks and associated mitigations; escalate when appropriate.
Clario is a leading provider of endpoint data solutions to the clinical trials industry, generating high-quality clinical evidence for life sciences companies. Our global team of science, technology, and operational experts have supported over 70% of all FDA drug approvals since 2015.
Assisting in the management of cross-functional sub teams to facilitate timely planning, execution, tracking, and completion of NDA-related clinical deliverables.
Setting up meetings, drafting agendas and detailed minutes, and tracking actions through completion.
Assisting in the identification of issues impacting plan execution and working with the team to identify risks and develop mitigation strategies
Amylyx is dedicated to ushering in a new era for treating diseases with high unmet needs. They value urgency, rigorous science, and unwavering commitment, demonstrated by their experienced team ready to take action.
Responsible for ensuring that the Value Hub adheres to regulatory standards, contract requirements, and internal quality benchmarks.
Analyzing compliance data, preparing detailed reports, and working closely with various departments to maintain and improve compliance and quality standards.
Supporting the understanding of local regulatory requirements, completion of local audits, participation in quality committees, and supporting health plan needs and interactions to ensure consistent implementation of contractual obligations.
CommonSpirit Health has more than 700 care sites across the U.S. from clinics and hospitals to home-based care and virtual care services. They are committed to building healthy communities advocating for those who are poor and vulnerable and innovating how and where healing can happen both inside their hospitals and out in the community.
Provide guidance for Affirm’s Product and Operations teams on applicable regulatory requirements related to any changes to products or services, issue remediation, and marketing reviews.
Review and approve financial services marketing materials to ensure they comply with regulations and industry standards.
Support responses to regulatory and bank-partner inquiries, audits, and examinations through second-line reviews and documentation/evidence.
Affirm is reinventing credit to make it more honest and friendly, giving consumers the flexibility to buy now and pay later without any hidden fees or compounding interest. The Legal, Compliance, and Public Affairs team is a group of dedicated professionals committed to helping Affirm scale, innovate, and provide outstanding products for consumers, merchants, and key partners.
Be the primary face to the client during the implementation process
Conduct impact analysis with client to determine the appropriate requirements for a smooth and successful implementation
Create and maintain a detailed project plan and open items log for project monitoring purposes
SmithRx is a rapidly growing Health-Tech company aiming to disrupt the Pharmacy Benefit Management (PBM) sector. They have a mission-driven and collaborative culture that inspires their employees to do their best work and are guided by their company values: Integrity, Courage, and Together.