Source Job

• Strategically support and lead the development of proposals, including strategy development and leading TCs.
• Ensure high quality client-focused proposals, budgets, and client grids for new business opportunities.
• Support process improvement initiatives and development of junior staff through training and education.

PrimeVigilance is a specialised mid-size pharmacovigilance service provider established in 2008, covering Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. With staff across Europe, North America and Asia, we value employee experience, well-being, and mental health, fostering a healthy work-life balance.

• Lead and oversee Commercial Quality operations across the Ergomed Group, including managing Quality Cost Grids and supporting bid activities.
• Act as a subject matter expert for GxP Commercial Quality, driving quality input into client proposals and presentations.
• Mentor and develop quality staff to enhance their competence and confidence in becoming subject matter experts.

PrimeVigilance is a specialized mid-size pharmacovigilance service provider with staff across Europe, North America and Asia. It values employee experience, well-being and a healthy work-life balance to nurture a high-quality client service environment.

• Lead global pharmacovigilance operations for clinical trials and post-marketing safety.
• Ensure regulatory compliance with FDA, ICH, and GVP standards across international markets.
• Build and mentor high-performing teams while driving business development and financial performance.

The company is a fast-growing clinical research organization specializing in pharmacovigilance and drug safety. It emphasizes operational excellence, regulatory compliance, and patient safety, with a global reach and a collaborative culture.

• Lead the study start-up process, developing strategy and coordinating regulatory deliverables to meet targets.
• Serve as primary contact for start-up activities, prepare and review regulatory documents, and ensure compliance with ICH-GCP and regulations.
• Manage essential document collection, site correspondence, contract negotiations, and support team training and budget monitoring.

Ergomed is a mid-sized contract research organization specializing in oncology and rare disease. The company has a global presence with operations in Europe, North America, and Asia, and emphasizes employee well-being, work-life balance, and career development.

• Lead CMC regulatory activities for IND/CTA development and maintenance to support clinical trials and future MAA/NDA/BLA submissions.
• Prepare and review CMC regulatory documents, assess changes, and collaborate cross-functionally to ensure compliance.
• Represent regulatory on study teams and maintain knowledge of US and international regulations.

Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for cancer patients. The company targets the RAS/MAPK pathway and fosters a collaborative, mission-driven culture.

• Ensure quality and consistency across multiple tactics led by internal and external partners.
• Act as in-house client liaison, communicate client expectations to cross-functional teams, and drive strategic partnerships.
• Supervise projects to meet strategic and tactical goals, provide final approval on deliverables, and manage project risks.

Real Chemistry is a global healthcare communications and marketing agency focused on transforming healthcare through a blend of scientific expertise, human-centered creativity, and AI-driven insights. The company culture emphasizes being best together, impact-obsessed, and committed to excellence for clients and colleagues.

• Lead the delivery of complex global projects for clients within the contract research, life sciences, or regulated healthcare sectors.
• Manage the full project lifecycle, including planning, execution, monitoring, reporting, delivery, and closure.
• Coordinate cross-functional international teams and develop project plans, timelines, budgets, and resource allocation strategies.

Welo Life Sciences is a specialized language and technology partner serving pharmaceutical, CRO, and medical device organizations in regulated global markets. It is a part of Welo Global brand, delivering solutions within a secure, audit-ready framework supported by seven ISO certifications.

• Serve as a subject matter expert for site management and monitoring strategies across complex clinical studies.
• Collaborate with clinical teams, investigators, and stakeholders to ensure compliance, data quality, and trial success.
• Mentor CRA staff, resolve escalated issues, and support site qualification, initiation, monitoring, and close-out visits.

Jobgether is a platform that uses AI-powered matching to connect candidates with job opportunities. They operate as a global healthcare and technology environment, offering professional growth and innovative solutions.

• Manage day-to-day regulatory affairs support, including clinical trial applications and compliance with global regulations.
• Provide expert guidance to project stakeholders, ensuring timely and high-quality service delivery.
• Develop regulatory strategies and tools, staying current with industry best practices and regulatory changes.

Alimentiv provides global regulatory affairs support services for clinical research. The company emphasizes high-quality service delivery, compliance with industry standards, and a collaborative culture.

• Serve as primary point-of-contact and escalation point for clients, coordinating all functional services to meet timelines and budget.
• Manage the study budget, financial health, and project profitability, ensuring compliance and accurate forecasting.
• Develop robust project plans with risk management, maintain quality oversight, and lead internal and client meetings.

Precision for Medicine is a CRO that integrates clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences, focusing on Oncology and Rare Disease. The company has an operational scale and expertise to bring life-changing therapies to patients.

• Provides study-level oversight and leadership for global clinical trials from inception through closure, managing vendors, recruitment, and cross-functional teams.
• Develops and manages study materials including protocols, regulatory submissions, and budgets while ensuring compliance with quality standards and inspection readiness.
• Contributes to system management like EDC, IRT, and eTMF, and supports process improvement initiatives or serves as a mentor.

AbbVie discovers and delivers innovative medicines and solutions to address serious health issues in immunology, oncology, neuroscience, and aesthetics. As a global biopharmaceutical company with a robust pipeline, they emphasize integrity and innovation, serving patients worldwide with a dedicated team.

• Provide study oversight as primary liaison between CRAs, internal staff, site staff, client personnel, and external vendors.
• Ensure clinical monitoring activities comply with SOPs, regulations, GCP, KPIs, and study-specific requirements.
• Develop and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines.

ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996, supporting research behind innovative treatments in pharmaceutical, biotech, and medical device industries. They foster a collaborative community where team members feel valued, supported, and empowered to make a meaningful impact on global health.

• Lead global regulatory strategy for one or more drug development programs, with emphasis on submissions and health authority interactions.
• Plan, manage, and create Clinical Trial Applications, Market Applications, and amendments, ensuring high-quality documents.
• Collaborate with cross-functional teams to create and negotiate clinical-regulatory development paths and prepare for health authority meetings.

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

• Lead CMC regulatory strategy for small molecule drugs in global Phase 1-3 trials.
• Write and manage investigational regulatory submissions for US, EU, and ROW.
• Support risk mitigation and GMP compliance across development programs.

Recursion is a clinical-stage TechBio company decoding biology to radically improve lives. The company employs a global team and fosters a culture of bold action, care, and collaboration.