Clinical Trial Regulatory Affairs Specialist (Boston, MA)
• Documentation Management: Preparing, reviewing, and submitting regulatory documents, such as Investigational New Drug (IND) applications and Clinical Trial Applications (CTAs).
• Ethics Committee Coordination: Assisting in the preparation and submission of clinical trial site ethics review board applications and maintaining communication throughout the study.
• Audit Support: Supporting external regulatory agency audits by providing necessary documentation and regulatory input to minimize potential findings of non-compliance. This role encompasses a variety of study types, including observational and interventional studies, across all clinical trial phases from Phase 1 to Phase 4. We offer flexibility for this position to start as a part-time or outsourced role, with the potential to transition into a full-time position based on performance. What We’re Looking For • Experience: A minimum of 10 years in regulatory affairs within the biotechnology or pharmaceutical industry, with direct involvement in clinical trial regulatory processes.
• Knowledge: Strong understanding of clinical trial regulations, Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and ethical standards.
• Skills: Excellent organizational, communication, and interpersonal skills, with a keen attention to detail and strong analytical abilities.
• Education: Bachelor’s or master’s degree in regulatory affairs, life sciences, or a related field.
Recommended Jobs
Assistant Site Manager - Part-Time
Make a difference with your mornings! Community Nutrition Program seeks Part-Time Dining Site Assistants in Belmont to help run our community dining program for older adults. This program helps allevi…
Warehouse Janitorial Associate
Kellermeyer Bergensons Services (KBS) has immediate full-time, permanent openings to join our Warehouse Cleaning/Janitorial crew in Charlton, MA. If you enjoy working in a fast-paced environment and …
Diagnostic Sonographer - Days
Diagnostic Sonographer - Days Job Ref: 32677 Category: Radiology & Imaging Location: Emerson Hospital, 133 Old Road to Nine Acre Corner, Concord, MA 01742 Department: Diagno…
Cardiac Surgery NP/PA
The Center for Advanced Cardiac Surgery at Boston Medical Center – Brighton Boston, MA, is seeking a full-time, licensed Physician Assistant or Nurse Practitioner for a non-operative and a first as…
Family Nurse Practitioner (FNP) Job - Community Health in Boston, MA
A large federally qualified healthcare system with locations throughout Eastern Massachusetts is hiring an experienced family nurse practitioner to join its primary care team. This full-time position…
Delivery Driver/Warehouse Selector
Job Description Job Description Description: We are an industry-leading family-owned hospitality/culinary concierge service in South Shore Massachusetts, delivering superior products to food s…
Administrative Coordinator
Skills: Strong judgment, adaptability, and excellent communication skills RATE: $31.88/hr. On W2 The incumbent will be responsible for managing the Commissioner's schedule that is comprised of …
Performance Marketing Manager (Remote US)
Job Description Job Description Directive Consulting is the performance marketing agency for SaaS and Tech companies. We use Customer Generation (a marketing methodology developed by us) which fo…
Nurse Manager | Springfield
Job Description Job Description Why Work for Gandara : Explore the career pathways in Behavioral Health, Substance Use and Recovery, Community Based Clinical services, Adolescent and Family s…
Process Reliability Manager
Job Description Job Description Job Description Summary The Reliability Engineer will work closely with Sibelco plant maintenance, production and leadership teams to develop and utilize effe…