(Senior) Start Up & Regulatory Specialist

Qualifications: Minimum Required: • Bachelors’ 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. • 5 years or more as a Regulatory or SU specialist in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies. Other Required: • Excellent communication and organizational skills are essential. • Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required. • Fluency in English and Turkish. • Ability to prioritize workload to meet deadlines. • Experience in driving cross-functional activities, coordination and oversight of a team. Preferred: • Must have relevant regulatory and site start-up (feasibility, contract negotiations, CA/EC/IRB submissions) experience for the particular country. Experience in country set up would be highly beneficial. • Must have experience using milestone tracking tools/systems. • Must be able to assist junior SU specialists in problem resolution. • Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science Competencies • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements. • Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information. • Excellent organizational skills. • Ability to work independently in a fast-paced environment with a sense of urgency to match the pace. • Must demonstrate excellent computer skills. • Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade. • Flexible attitude with respect to work assignments and new learning. • Occasional travel may be required #LI-OS1 #LI-Remote We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company. Any data provided as a part of this application will be stored in accordance with our . For CA applicants, please also refer to our CA Privacy Notice . Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com . Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at myHR@precisionmedicinegrp.com so we can investigate and take appropriate action.