Assume leadership and functional representation for projects ensuring effective coordination and management of regulatory deliverables.
Perform quality control of regulatory intelligence screening and ensure maintenance of the regulatory intelligence database.
Provide regulatory strategic input to internal and external customers and promptly identify and address any risk.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They have achieved global organic growth year after year, with staff based across Europe, North America, and Asia, covering services within Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.
Under the direction of a senior member of the team, assume leadership and functional representation for projects of low complexity assigned ensuring effective and rapid coordination and management of deliverables striving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
Perform quality control of regulatory intelligence screening of legislative requirements updates and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.
Provide internal teams and Clients with expertise and guidance on national requirements.
Ergomed Group is a rapidly expanding global full-service mid-sized CRO specializing in Oncology and Rare Disease. The company includes the more specialised brands- PrimeVigilance, Adamas Consulting and Ergomed CRO and values employee experience, well-being and mental health.
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.
Serves as a dedicated strategic partner to assigned operational or functional business areas.
Translates business needs and regulatory expectations into effective, practical, and inspection-ready learning solutions.
Accountable for shaping learning approaches that support business outcomes, regulatory compliance, and inspection readiness.
Vertex Pharmaceuticals is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. They employ scientists, business professionals, and researchers united around a common goal–to discover, develop, and deliver innovative medicines.
You will function as a central knowledge holder in a specialized team within Pharma Regulations & Audits.
You will carry out audits and compliance checks, formulate improvement measures and supervise the implementation.
You will implement projects to improve compliance and quality processes.
Redcare Pharmacy is Europe’s leading online pharmacy driven by innovative technologies and the passion of its employees. The company strives for an inspiring and collaborative work environment where everyone feels valued and contributes to their mission: “Until every human has their health.”
Lead cross-functional project teams for 503a and 503b sterile product launches, from ideation through R&D to commercial launch.
Lead expansion and continuous improvement workstreams that support 503a and 503b sterile product development.
Build and maintain integrated project plans including key milestones, timelines, resource requirements, risks, and mitigation plans.
Hims & Hers is a health and wellness platform committed to making people feel great through better health by delivering affordable and personalized care. They are a public company traded on the NYSE under the ticker symbol “HIMS” with a talent-first flexible/remote work approach.
Assist in preparing regulatory submission documents in compliance with global regulatory requirements.
Manage the preparation and submission of preclearance and promotional material submissions to the U.S. FDA.
Format complex Word documents to generate compliant regulatory reports including complicated tables and graphs.
Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases. Our mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.
Independently lead multiple product development programs.
Serve as the primary technical owner for assigned projects.
Drive continuous product improvement initiatives.
The VMS Co-Op includes fast-growing companies in the Vitamins, Minerals, and Supplements (VMS) space, such as OLLY and SmartyPants. This company values collaboration and offers various benefits including parental leave and wellness stipends.
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.
Prepare, compile, and submit regulatory documents to IRBs/ECs
Support migration from Complion to Florence eRegulatory
Maintain CVs, licenses, and GCP documentation
UniTriTeam is a global organization supporting clinical research sites and organizations through staff augmentation and technology solutions. They pride themselves on creating opportunities for their team members while delivering exceptional results for their clients.
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.
Establishes and maintains a document management system for regulatory electronic files.
Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks.
Modifies and/or develops informed consent forms and updates and manages protocol, investigator drug brochure and consent form modifications or amendments in compliance with IRB policy and HIPAA.
Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, is one of the largest community-based cancer programs advancing oncology treatments and improving outcomes for cancer patients globally. They look for mission-driven candidates who want to advance the fight against cancer and make a difference in patients' lives.
Support and observe clinical site monitoring services inhouse.
Provide monitoring and site management activities for full-service studies.
Conduct remote data review, support data query and closure activities.
Alimentiv is a global contract research organization (CRO) providing clinical trials and research services. While the employee count is not provided, they appear to foster a collaborative environment.
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.
Independently oversees all aspects of study site management to ensure patient safety is protected.
Independently conducts all forms of site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits.
Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision's high quality and professional image.
Precision Medicine Group is expanding its capabilities across Latin America. They are an Equal Opportunity Employer, with employment decisions made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
Prepare regulatory filings, conduct routine audits, and organize documentation for legal reviews.
Collaborate with attorneys and business leaders to support compliance initiatives and respond to regulatory inquiries.
Provide guidance to internal stakeholders on compliance requirements.
AffirmedRx aims to improve healthcare outcomes by bringing clarity, integrity, and trust to pharmacy benefit management. They are committed to making pharmacy benefits easy to understand, straightforward to access, and always in the best interest of employers. and the lives they impact.
Review analytical data for release, stability, and in-process testing.
Oversight of laboratories including investigations for out of specification, out of trend, deviations, and/or anomalous results.
Follow up with the contract laboratories to correct any deficiencies/omissions in the provided test packages.
BridgeBio pioneers a “moneyball for biotech” approach. They pool projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation and build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines.
Serve as the primary point of contact for a strategic enterprise customer.
Act as a subject matter expert in all aspects of SDS Authoring from a global perspective.
Author, review, and approve complex Safety Data Sheets (SDS) in alignment with global GHS requirements.
3E is dedicated to creating a safer and more sustainable world. They provide regulatory expertise and technology related to chemicals and supply chains for over 5,000 customers globally and have over 35 years of experience and 15 locations.
Document and continuously improve legal and compliance processes, playbooks, and SOPs.
Support Machinify’s compliance programs in planning and executing projects and initiatives, and managing operational frameworks and workflows.
Research laws, regulations, contractual obligations, and internal requirements; synthesize findings into clear, actionable outputs.
Machinify is a leading healthcare intelligence company delivering value, transparency, and efficiency to health plan clients. They have over 85 health plans deployed, including many of the top 20, and representing more than 270 million lives, and they are constantly reimagining what’s possible in healthcare.
Oversee and drive CMC project plans, ensuring deliverables align with overall project objectives and timelines.
Facilitate cross-functional collaboration by leading CMC sub-team meetings and tracking action items.
Proactively identify and mitigate risks, maintaining risk registers and implementing contingency strategies.
Akero Therapeutics, a Novo Nordisk company, is focused on discovering and developing transformational treatments for patients with serious metabolic diseases. They have a team-oriented culture where everyone feels inspired to bring their best thinking to work, and to bring out the best in others.