Regulatory and Start Up Specialist

October 18

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $35.2M Venture Round on 2021-03

Description

• Precision for Medicine is a CRO integrating clinical trial execution with scientific expertise and data sciences. • Responsible for delivery of site activation readiness, preparation of Clinical Trial Application Forms, and local submissions. • Interaction with CA/EC for study purposes, maintenance of project plans, and communication with key functions. • Ensure audit readiness and may support feasibility group in site outreach.

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 or SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies. • Experience in submissions to the Taiwan FDA • Experience in working on EC/IRB submissions in Taiwan • Strong communication and organizational skills. • Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required. • Fluency in English. • Relevant regulatory and site start-up (feasibility, contract negotiations) 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.