Manage the end-to-end process for complaints and deviations.
Analyze quality metrics and suggest process optimization.
Jobgether uses an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. The final decision and next steps (interviews, assessments) are managed by their internal team.
Lead development of phase-appropriate formulations and manufacturing processes for solid oral dosage forms.
Oversee technology transfer from development to clinical and commercial manufacturing.
Manage CDMOs, including selection, oversight, and performance management.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. They are a fully remote company headquartered in Radnor, Pennsylvania.
Monitor updates to EP, USP, Mexico Ph, ChP, and JP.
Analyze changes in compendial requirements.
Ensure timely implementation of compendial changes.
Vertex Pharmaceuticals is focused on the discovery, development and commercialization of medicines. They strive to transform the lives of people with serious diseases.
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.
Develop and maintain a quality audit program for the Clinical Review Team.
Ensure high-quality reviews and adherence to regulatory requirements.
Deliver exceptional member, provider, and employee experiences.
SmithRx is a rapidly growing Health-Tech company that aims to disrupt the Pharmacy Benefit Management (PBM) sector using technology and customer service. The company has a mission-driven and collaborative culture, with hundreds of thousands of members onboarded since 2016.
Manages curricula and learner roles, including periodic review of curricula, learner roles, and training requirements with department heads and QMS Admin.
Coordinates with study team leads to update study-specific training documents, routes for approvals, and manages study team learner role membership in the LMS.
Coordinates with document owners and Doc Control to create or revise Training Requirements with new or revised controlled documents and training materials.
Celcuity is a clinical-stage, publicly traded biotechnology company focused on extending the lives of cancer patients through targeted therapies for solid tumor indications. The company was founded to develop a better way to treat the cellular drivers of tumor growth.
Provide day-to-day technical support for gummy manufacturing operations.
Lead structured investigations of process deviations, yield losses, and quality issues.
Support pilot-to-production scale-up, verification/validation activities, and technical transfers.
They are the VMS Co-Op, a group of fast growing companies in the Vitamins, Minerals and Supplements (VMS) space. The VMS Co-Op includes OLLY, SmartyPants and future acquisitions to come! This position's home company is OLLY.
Review and oversee the Quality Assurance/Quality Control (QA/QC) program for all project phases.
Conduct regular audits of contractor activities to verify conformity with design documents and project specifications.
Ensure contractors are utilizing the latest revisions of design documents, maintaining accurate records of changes and updates throughout the project lifecycle.
Sargent & Lundy is dedicated to providing comprehensive engineering, energy and consulting services for power plants and power delivery systems. We care about the health and well-being of our employees and are committed to supporting our team members in every aspect of their lives.
Ensure product quality by thoroughly testing new versions of AutoContour prior to release
Execute verification and validation (V&V) testing to maintain product integrity and performance
Partner with Success and Support teams to troubleshoot issues and support clinic implementations
Radformation transforms the way cancer clinics deliver care with innovative software that automates and standardizes radiation oncology workflows. They are a fully remote, mission-driven team united by a shared goal: to reduce cancer’s global impact.
Provide oversight for medical device software products through all phases of the development process.
Guide the software development team to define critical safety and performance requirements.
Support the timely handling of complaint investigations, change impact assessments, and CAPAs.
Oura's mission is to empower every person to own their inner potential with award-winning products that help their global community gain a deeper knowledge of their readiness, activity, and sleep quality. They have offices in San Francisco, San Diego and Los Angeles for those who prefer hybrid or office settings, and they're committed to ensuring that their team members have what they need to do their best work.
Supports analytical development and characterization activities for late-stage biologic development leading to licensure application submission.
Takes a leading role in analytical characterization activities in support of comparability studies, heightened characterization studies, method development, control strategy development.
Supports preparation of regulatory submissions and regulatory engagement as technical subject matter expert as needed.
Akero Therapeutics, a Novo Nordisk company, is focused on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. They are a team of problem solvers dedicated to pursuing bold scientific approaches and have a collaborative spirit, breeding a culture where everyone feels inspired.
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.
Work with project teams on problem identification and resolution.
Assist project teams with the development and execution of project quality plans.
Sargent & Lundy provides comprehensive engineering, design, and consulting services for the power industry and high-tech sectors. They are committed to creating a positive employee experience through competitive compensation and benefits.
Preparation and submission of regulatory dossiers.
Advise on strategies and registration requirements for product development and marketed products.
Lead regulatory assessment and actions for changes to product and QMS processes.
Convatec is a global medical products and technologies company focused on solutions for the management of chronic conditions. They have more than 10,000 colleagues and provide products and services in around 90 countries, promising to be forever caring.
Provide post-go-live administrative support for multiple clients
Solutioning and configuration of Vault applications to meet customer needs
Assistance with Quality processes including SOPs, Quality Events, CAPAs, Deviations, Change Control, Audits, and Training
Veeva Systems helps life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies, they surpassed $3B in revenue and are a public benefit corporation committed to balancing the interests of customers, employees, society, and investors.
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.
Conduct chart audits for patient encounters, ensuring accurate medical record documentation.
Identify opportunities to improve documentation quality and clinical compliance.
Support the contact center by addressing patient questions and providing education.
Planned Parenthood South Atlantic provides reproductive health care. They are committed to equitable and transparent pay practices and value their employees.
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.
Responsible for the strategic oversight, operational management, and continuous improvement of the Trial Master File (TMF).
Lead TMF quality review activities, including ongoing completeness checks ensuring that all required documents are accurately filed.
Identify eTMF trends and commonly misfiled documents, and lead efforts to identify, communicate, and resolve document inconsistencies.
Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Founded in 2019, they are continuously expanding their presence and global footprint and searching for high-impact individuals.
Assists in the maintenance of structures and processes which support improvement and patient safety.
Uses clinical knowledge in formal and informal consultation with individual staff, clinicians and managers, to address clinical quality and safety concerns.
Participates in clinical adverse event task groups.
Dartmouth Health is a nationally recognized Academic Medical Center set in the White Mountains of New Hampshire, stretching over New Hampshire and Vermont. They offer a rigorous, research-focused environment and are anchored by the academic Dartmouth Hitchcock Medical Center in Lebanon, NH.