---
title: '(Senior) Start Up & Regulatory Specialist at Precision for Medicine'
canonical: 'https://feeny.ai/job/senior-start-up-regulatory-specialist-precision-for-medicine-turkey-kp6er0bdtapk'
type: 'job'
last_seen: '2026-09-14'
---

# (Senior) Start Up & Regulatory Specialist at Precision for Medicine

- **Company:** Precision for Medicine
- **Location:** Turkey
- **Work type:** remote
- **Posted:** 2026-08-28
- **Last confirmed live:** 2026-09-14
- **Apply:** https://job-boards.greenhouse.io/pfm/jobs/6173363004

## Job description

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.

As our company continues we grow we are seeking a Principal 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.

- Responsible for driving country level submissions and site activation processes by coordinating activities when multiple RSSs are assigned within the country.
- Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC 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 as relevant.
- Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.
- 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 collaboration.
- Prepare, review and manage collection of essential documents required for site activation/IMP release.
- Customize country/site specific Patient Information Sheet and Informed Consent Forms.
- Responsible for/facilitates the translation and co-ordination of translations for documents required for submission.
- Maintain communication with other key functions participating to country start up i.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 but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements 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.
- Keep an updated knowledge of the local clinical trial laws, regulations and help distributing this 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.
- May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.
- Will support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
- Will support development of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
- Will mentor staff on local country regulations, submissions and internal procedures, as well as on PFM SSU specific guidance and tools.
- Can assume ownership of departmental process improvements / initiatives, including finalization, roll out and periodic reviews.
- May interact with clients to provide activation readiness status updates, request documents or document review, and participate in proposal activities, including slide development and client presentation as required.
- May act up in the role of Start Up Lead to drive site start up activities to meet activation timelines on smaller or single country studies or by acting as a regional Start Up Lead on larger global studies under the direction of the global Start Up Lead.
- May interact with clients during KOMs, including slide development and client presentation,as required.

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 [Privacy Policy.](https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fprivacy-policy%2F&data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=9DgboiHTFPrNYVhdKhyfdwVyNYwUvZbP%2FroLdWIIfxw%3D&reserved=0) For CA applicants, please also refer to our [CA Privacy Notice](https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fca-applicants-privacy-notice%2F&data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=tfAqqMZsG%2B11IchL45HFFVbfECCkYqQpNr0PQxrMFJU%3D&reserved=0).

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.

## About Precision for Medicine

## Company Overview
- **One-liner**: Precision for Medicine is a global clinical research organization (CRO) and laboratory services provider specialized in accelerating the development of precision therapies for oncology, rare disease, and other complex conditions.
- **Entity Type**: Private – subsidiary of Precision Medicine Group (a private holding company)
- **Headquarters**: Not explicitly stated in sources; likely around the Washington D.C./Maryland area (Precision Medicine Group HQ is in Bethesda, MD). The company operates globally with labs in North America and Europe.
- **Founded**: 2012 (company began), but the team has over 25 years of clinical trial experience
- **Founders**: Not publicly disclosed on provided sources; leadership includes a founder role but name not given.

## Core Business
- **Primary industries**: Contract Research Organization (CRO) services, central laboratory services, biospecimen solutions, data intelligence for clinical development.
- **Target customers**: Biotechnology and pharmaceutical companies developing precision medicines, especially in oncology and rare disease (B2B, mid-to-large pharma).
- **Mission/purpose**: “Bringing life-changing therapies to patients by integrating laboratory expertise, clinical trial excellence, and data intelligence to deliver critical insights into patient biology.”

## Products & Services
- **Global CRO Services**: Full-service clinical trial management with a focus on early- and late-phase development, regulatory support, project management, and site startup. Over 75% of trials are in oncology.
- **Global Laboratory Services**: Translational and biomarker sciences, including specialty labs for genomics, flow cytometry, molecular diagnostics, and central lab testing. Operates 5 specialty labs in the US and Europe.
- **Biospecimens**: Access to over 11 million tissue, cellular, and biofluid specimens for research.
- **Data Intelligence**: AI-enabled data ecosystem for sample management, biomarker analysis, biostatistics, and decision support (includes a conversational AI virtual assistant).
- **Diagnostics and Companion Diagnostics (CDx)**: Development and commercialization of diagnostic tests aligned with therapies.

## Market Standing
- **Valuation / Market Cap**: Not publicly disclosed (part of private Precision Medicine Group).
- **Key Metric**: ~3,500 employees; 2,500+ clinical trial and lab projects; 70% of clinical trials in oncology; 25+ years of combined experience.
- **Notable Investors/Partners**: Sources mention “$30B in investments raised for biotech in the last 5 years” (general biotech investment, not specific to Precision). No specific lead investors listed; backed by private equity (Precision Medicine Group is owned by institutional investors).
- **Growth Signals**: Awarded the 2025 Fierce Biotech CRO Award for Innovative Solutions in Drug Development. Active hiring with 129 job openings globally (as of July 2026). Strong remote/hybrid work options across many roles.

## Competitive Advantages
- **Integrated CRO + Lab + Data**: One organization covering the full spectrum from biospecimens to late-phase trials, reducing inefficiencies of working with separate vendors.
- **Specialization in complex indications**: Deep expertise in oncology and rare disease, where protocols are highly complex.
- **Right-sized CRO model**: Assigns employees to no more than 2–3 trials at a time, offering more attention than large “Big Five” CROs (positioned as “antidote to Big Five Fatigue”).
- **AI-enabled data intelligence**: Unified ecosystem with conversational AI to extract insights from siloed data.

## Strategic Focus
- Continue expanding capabilities in precision medicine development, particularly in early-phase oncology and rare disease.
- Leverage data intelligence and AI to improve trial efficiency and patient matching.
- Scale global clinical operations (recent push into Asia Pacific, Latin America, and Eastern Europe).

## Why Work Here
- **Culture**: Employee-driven mission “to help patients get access to innovative treatments.” Collaboration across functions is emphasized, with a focus on complex and impactful therapies.
- **Work environment**: Strong remote/hybrid options – job postings span remote roles in the US, Canada, Europe, Asia, and Latin America. Offices and labs exist in multiple countries.
- **Perks & growth**: Not explicitly detailed, but the company invests in career development (e.g., roles from CRA to Director level). 25 years of history and a growing global footprint indicate stability and upward mobility.
- **Engineering & science culture**: Teams include clinical scientists, data engineers, lab professionals, and operations – a blend of deep science and tech.

## Sources
1. [Precision for Medicine – Homepage](https://www.precisionformedicine.com/)
2. [Precision for Medicine – Our Story](https://www.precisionformedicine.com/about-us/our-passion/)
3. [Precision for Medicine – Leadership](https://www.precisionformedicine.com/about/leadership)
4. [Precision for Medicine – Careers (Greenhouse)](http://job-boards.greenhouse.io/pfm)
5. [Precision for Medicine – LinkedIn](https://www.linkedin.com/company/precision-for-medicine)

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