Senior Regulatory And Startup Specialist

Summary

Join Precision for Medicine, a leading CRO, as a (Senior) Regulatory and Start-Up Specialist! This fully remote position based in France requires expertise in site activation, project management, and contract negotiation. You will be responsible for timely and high-quality delivery of site activation readiness, maintaining project plans, and communicating with key stakeholders. The ideal candidate possesses a Bachelor's degree in life sciences or a related field, along with at least one year of relevant experience in the CRO or pharmaceutical industry. Fluency in French and English is essential. We offer a supportive environment where your contributions are valued and nurtured.

Requirements

• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience
• 1 year or more as a Regulatory/ SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies
• Experience drafting, reviewing and negotiating agreements related to clinical research
• Experience developing and negotiating the budget
• Strong communication and organizational skills
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required
• Fluency in French and English

Responsibilities

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks
• Maintenance of project plans and project trackers
• Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including site contracts and budget negotiation requirements
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department

Preferred Qualifications

• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience for the particular
• Experience using milestone tracking tools/systems
• Ability to prioritize workload to meet
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory
• Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of
• Strong organizational
• Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located
• Ability to work independently in a fast-paced environment with a sense of urgency to match the
• Must demonstrate excellent computer
• Good communication, presentation, interpersonal skills, both written and spoken, with an aptitude to learn how to inform, influence, convince, and persuade

Benefits

This position can be offered fully home based