[Hiring] Regulatory and Start Up Specialist @Precision Medicine Group

Role Description

As our company continues to grow, we are seeking a Regulatory and Start Up Specialist to join our growing team. Essential functions of the job include but are not limited to:

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
• Interaction with CA/EC for study purposes and handling responses to the CA/EC.
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team.
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership informed.
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.
• Partner with the assigned site CRA to ensure alignment in communication and secure site review and manage collection of essential documents required for site activation/IMP release.
• Customize country/site specific Patient Information Sheet and Informed Consent Form.
• Responsible for/facilitates the translation and coordination of translations for documents.
• Maintain communication with other key functions participating in country start-up, e.g., 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 but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on-time site activation for the assigned sites in the country.
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
• May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.
• Keep an updated knowledge of the local clinical trial laws, regulations and help distribute their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations.
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/or study specific plans in the relevant TMF.
• May support the clinical team performing Pre-Study Site Visits.

Qualifications

• 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.
• A qualification in Pharmacy/work experience as a Pharmacist would be highly beneficial.
• Demonstrated experience as a Regulatory or Start Up specialist (or comparable role) in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies.

Requirements

• Strong communication and organizational skills.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English.

Benefits

• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/EC/IRB submissions) experience.
• Experience using milestone tracking tools/systems.
• Ability to prioritize workload to meet deadlines.
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science.