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.
Oversight of all project related quality activities
Drive project related quality improvement and providing quality advice
Client management including direct oversight for client quality related activities for project
PrimeVigilance, part of Ergomed Group, is a mid-sized pharmacovigilance service provider established in 2008. They offer services in medical information, pharmacovigilance, regulatory affairs, and quality assurance, with staff across Europe, North America, and Asia. They maintain long lasting relationships and becoming one of the global leaders in its fields.
Responsible for timely and quality delivery of site activation readiness, mitigating risks.
Prepare Clinical Trial Application Forms and submission dossiers for regulatory bodies.
Maintain project plans, trackers, and regulatory intelligence tools.
Precision for Medicine is a Clinical Research Organization with an integrated offering that combines clinical trial designs, operational and medical experts, and biomarker and data analytics solutions. They have a passion for rare diseases and oncology, and are growing their team.
Assist with investigator recruitment activities and site feasibility tasks.
Perform essential document collection, review, and maintenance activities.
Act as site contact for study and site management issues.
Precision for Medicine supports life sciences companies in the use of precision medicine by helping them design and execute clinical trials. They focus on biomarker-led strategies and have expertise in data science, clinical trial management, and laboratory services.
Global Regulatory Lead for a cutting edge RPT programs
Clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products
Lead the preparation and submission of regulatory filings
RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, develops transformative radiopharmaceutical therapies. They blend the spirit of an emergent biotech with the expertise and resources of a leading innovator in oncology, fostering a multidisciplinary team where ideas are valued.
Monitor the progress of clinical studies at investigative sites, ensuring studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
Coordinate activities to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).
Identify potential study risks and propose solutions on how to mitigate them.
Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences to improve therapies for patients, with a focus on Oncology and Rare Disease. They cultivate a culture, and have high CRA retention rates.
Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting.
Prepare and review IND submissions, communicate with the FDA, and prepare for FDA audits.
Lead study start-up/maintenance: prepare and submit all required regulatory documents for new/current study applications and successfully open/close studies from inception to accrual.
Emory University is a leading research university fostering excellence and attracting world-class talent to innovate today and prepare leaders for the future. They welcome candidates who can contribute to the excellence of their academic community.
Responsible for delivery of site activation readiness within the assigned country/sites.
Preparation of Clinical Trial Application Forms and submission dossier for submission to CA, EC, and other applicable local bodies.
Act as SME for collection and maintenance of site level critical path to Site Activation data points.
Precision Medicine Group is an organization that works in the medical field. 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.
Serve as Global Regulatory Lead for the Phase 3 HCM program.
Provide strategic regulatory input and leadership at program governance forums and core team meetings.
Plan, prepare, review, and oversee submissions to regulatory authorities supporting late-stage development and registration readiness.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, they represent an outstanding opportunity for ambitious, mission-driven professionals.
Improve clients' Regulatory Information Management processes.
Work collaboratively with diverse teams to drive business value.
Enhance efficiency and compliance for clients in a rapidly evolving landscape.
Jobgether uses an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Their system identifies top-fitting candidates, and this shortlist is then shared directly with the hiring company.
Serves as Project manager of the PV Risk Management System to oversee, evaluate, characterize, strategize, implement, assess and track vera’s PV Risk Management obligations, commitments and proposed minimization measures.
Provide recommendations and guidance through subject matter expertise on risk management and risk minimization strategy to an assigned therapeutic area to ensure that product risk management strategies are consistent worldwide.
Work closely with cross-functional teams (e.g. Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, and Biostats) to ensure alignment of Vera’s global position for the PV risk management processes.
Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. They aim to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Their values inspire employees every day.
Conduct and report all types of onsite monitoring visits as well as remote visits.
Perform CRF review, source document verification and query resolution.
Be responsible for site communication and management.
PSI is a dynamic, global, mid-size company founded in 1995, bringing together more than 3,000 driven, dedicated, and passionate individuals. They work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
Collaborate with client teams to understand products and create regulatory strategies.
Implement strategies by engaging regulatory authorities and authoring submissions.
Proactively influence the regulatory environment to achieve business goals.
EVERSANA provides next-generation commercialization services to the life sciences industry, serving over 650 clients from biotech startups to established pharmaceutical companies. They have a global team of more than 7,000 employees committed to creating a healthier world by bringing innovative therapies to market and supporting patients.
Collaborate with Clinical Operations, Clinical Development, and other departments on Risk Based Quality Management.
Identify and evaluate the remediation of fundamental risks and quality issues at vendors and clinical sites.
Develop and implement inspection readiness plans and procedures for Health Authority inspections.
Kailera develops therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, Kailera is expanding and seeking talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join the team.
This position supports the Clinical Trial Patient Safety organization in evaluating and ensuring the quality of clinical trial patient safety data.
Responsible for world-wide surveillance of clinical trial patient safety data, including organization, resourcing, and continuous improvement efforts.
Manages assigned operational area(s)compound associated clinical studies and related systems to ensure clinical safety adverse event surveillance is managed in a compliant and timely manner.
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. They strive to have a remarkable impact on people’s lives across several therapeutic areas including immunology, oncology and neuroscience.
Performs on-site or remote monitoring visit activities.
Identifies investigators and verifies qualifications.
Trains investigational site staff as necessary.
Ergomed is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease. Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia. Our company allows for employee visibility, creative contribution and realistic career development.
Serve as QA owner for clinical-stage combination product complaints.
Ensure timely assessment of complaints for potential impact to patient safety.
Partner with Regulatory Affairs and Pharmacovigilance to support complaint-related regulatory submissions.
Akero Therapeutics, a Novo Nordisk company, is dedicated to discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. They foster a collaborative environment where diverse skill sets and backgrounds are valued, encouraging employees to bring their best thinking to work.
Oversight of site level tasks associated with efficient site activation.
Support the CRA team in preparing for site initiation visits (SIVs).
Perform initial contract and budget negotiations with the sites, as well as amended where applicable
Fortrea helps to turn the impossible into I'm possible. They deliver exceptional service to their patients, fueled by a shared commitment to teamwork and excellence.
Ensure the quality and compliance of clinical trials.
Interpret regulatory requirements.
Lead the development and implementation of quality assurance strategies.
Jobgether is a company, posting this job on behalf of a partner company. They use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements.
Identify, structure, and execute funded research collaborations and clinical partnerships.
Translate scientific requirements into a site-friendly operational plan.
Ensure GDPR/HIPAA-aligned processes, DPAs, data minimization, and participant withdrawal workflow.
Cephalgo is a Strasbourg-based technology company founded in 2020, developing AI solutions for safety, compliance, and trust in human-AI interactions. Backed by over €3 million in funding, they combine expertise in voice AI, data protection, and compliance to help enterprises build responsible AI systems.