Regulatory and Site Start Up Specialist

🕒 3 days ago

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $75M Private Equity Round on 2015-12

Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites • Preparation of Clinical Trial Application Forms as well as preparation of submission dossier for submission to Competent Authorities, Ethics Committees, and other applicable local bodies • 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 • 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 co-ordination of translations for documents. • Maintain communication with other key functions participating to country start up. • Act as SME for collection and maintenance of site level critical path to Site Activation data points, • May participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. • May support the clinical team performing Pre-Study Site Visits.

🎯 Requirements

• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline) • A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial. • 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. • Strong communication and organizational skills. • Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required. • Fluency in English.

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options