Experienced regulatory project manager role supporting Global Regulatory Leads to develop and execute globally aligned regulatory strategies and plans (IND/BLA/MAA), manage submission readiness (eCTD, Veeva RIM), facilitate Global Regulatory Subteam (GRST) meetings, and drive cross-functional alignment. Requires a scientific/healthcare degree, minimum 7 years industry experience (≥5 years in regulatory or regulatory program management), hands-on submission experience, and strong project management and communication skills.

Parexel seeks a Senior Medical Writer to author, edit, and manage clinical and regulatory documents (e.g., protocols, clinical study reports, CTD sections, investigator brochures, informed consents). The role includes quality control, project/document management, collaboration with cross-functional teams, and adherence to SOPs and regulatory guidelines (e.g., FDA/EMA, ICH-GCP). Requires a Bachelor's in life/health sciences and fluency in English.

Parexel is hiring a Biostatistician II to lead and execute statistical aspects of clinical studies of low to moderate complexity, contribute to protocol and analysis plan development, perform statistical analyses and quality control, and support regulatory submissions. Required: Master's + 3 years industry experience or PhD + 1 year; experience with clinical trials and statistical analysis; experience or skills in SAS or R; strong English communication and teamwork skills.

Parexel is hiring project management professionals for its Biotech Division to lead global clinical trials in Neurology, Psychiatry and Rare Disease. Roles include Project Leader, Senior Project Leader and Project Director; candidates should have a minimum of 2+ years leading global clinical trials (CRO/biotech/pharma preferred) and experience in scheduling, resource and budget management, team coordination and regulatory submissions.

Parexel seeks Project Leader and Senior Project Leader candidates to lead Metabolic / GLP-1 / Obesity global clinical studies. Roles involve leading project teams, managing day-to-day operations, project scheduling, resources and budgets, coordinating team activities, and supporting the full clinical development process through regulatory submissions. Minimum requirement: undergraduate degree in a clinical/health field (advanced degree preferred) and at least 2 years' experience leading global clinical trials in a CRO, biotech, or pharma setting.

Parexel FSP seeks a Clinical Trial Coordinator to support study start-up through closure, including trial/site administration, document and eTMF management, regulatory/IRB support, and budgeting/contract/payment activities (including budget negotiation and FCPA documentation). Position is hybrid with a minimum 1-day onsite requirement in Kirkland, Quebec. Minimum 1–2 years clinical research or relevant healthcare experience; business‑proficient English required.

Parexel is hiring a Senior Regulatory Affairs Associate to support worldwide post-approval CMC regulatory activities for biologics and vaccines. Responsibilities include developing submission strategies, assessing change controls, preparing and reviewing CMC submission content, coordinating with manufacturing/quality/supply chain, and managing regulatory information systems. Role is office- or home-based in several European countries; fluent English is required.

Acts as primary site contact and manages assigned clinical trial sites throughout all phases. Performs on-site and remote monitoring per ICH-GCP, Sponsor SOPs and protocol; manages regulatory documentation, maintains CTMS and eTMF records, supports audits/inspections, and drives site performance and patient recruitment. Oncology experience preferred. Requires minimum 2 years direct site monitoring experience and a bachelor’s degree preferred. Domestic and international travel required (approximately 65%–75%).

Parexel seeks a physician to provide medical leadership across protocol development, clinical data review, risk-based quality management, investigator engagement, and regulatory interactions for global clinical trials. The role is remote (UK/Germany locations listed) and requires at least 4 years of active clinical practice, fluency in English, and familiarity with ICH-GCP and clinical trial systems.

Senior QA Auditor role to lead, plan, and execute GxP audits (TMF, supplier, system, safety/pharmacovigilance); deliver high-quality audit reports, manage and escalate findings, coordinate global/regional audit programs, support inspections and serious breach investigations, and mentor auditors. Requires a bachelor's in a related discipline, minimum 2 years QA/auditing experience and at least 5 years' experience in clinical research/regulatory or related life sciences.

Deliver medical support and medical monitoring activities for clinical studies (including medical review of data, safety/serious adverse event review, medical input to PV workflows and regulatory safety reporting). Participate in study planning, protocol and study document development, training of study teams, audits/inspections, rotas for emergency medical contact, client engagement and support business development/proposal activities. Requires medical qualification, clinical practice experience, knowledge of GCP/ICH/FDA/EMEA guidelines and a minimum of 3 years' medical monitoring or medical data review experience.

Parexel seeks an experienced Study Physician/Medical Director to be medically responsible at the trial level for a sponsor in the EMEA region. Responsibilities include medical oversight from trial design through reporting, protocol preparation, defining medical risk-related data for quality plans, co-authoring clinical quality monitoring plans, and ongoing medical data review. Requires MD with minimum 4 years active clinical practice; clinical specialties (e.g., pulmonology, immunology, internal medicine, infectious diseases, pediatrics, rheumatology, emergency medicine) and experience in clinical development, CRO/pharma, pharmacovigilance, and ICH-GCP are desirable.

Parexel seeks a Senior Regulatory Affairs Associate / Labelling Strategist to develop and manage global labeling (CCDS, USPI, regional labels) and post-approval activities (artwork updates, safety variations, xEVMPD, PSURs). Role requires 7-8 years pharmaceutical regulatory affairs experience, proficiency with SPL and document/regulatory information management systems (e.g., Veeva, TVT, Docubridge), and cross-functional coordination across major markets including US, EU, Switzerland, Canada, and Australia.

Parexel seeks a Regulatory Labeling Specialist (remote, India) to manage product information and labeling throughout the product lifecycle, perform regulatory impact assessments for change controls, prepare and submit variations/notifications/renewals to Health Authorities, coordinate labeling and translations, and manage post-approval activities in Veeva RIMS. Requires a Bachelor's in a life science field, 6+ years in regulatory affairs/labeling, clinical expertise, and fluent English. Experience with xEVMPD is preferred.

Responsible for design and writing of trial outlines, protocols and amendments in collaboration with internal and external experts; create and deliver clinical/protocol training; establish and oversee Data Monitoring Committees and endpoint adjudication committees; maintain direct contact with investigative sites to support enrollment and address protocol questions. Requires project management/leadership experience, knowledge of GCP and regulatory requirements, and fluency in English and the host country language.

Parexel seeks a Senior Microsoft Power Platform Developer with 6+ years' hands-on experience building model-driven and canvas Power Apps, Power Automate workflows, Power BI/Power Pages, SharePoint configuration and Power Query data integrations. Role includes solution architecture, stakeholder collaboration, troubleshooting, code reviews and supporting Microsoft 365 capabilities. Based in India (Hyderabad) with remote work indicated.

Parexel seeks project leadership professionals to lead day-to-day operations of global clinical trials for biotech clients (including Oncology/Hematology), with responsibilities in project scheduling, resource and budget management, team coordination, and support across the clinical development process through regulatory submissions. Minimum stated requirement: 2+ years leading global clinical trials in project management.

Parexel seeks a Clinical Research Associate I-II to monitor clinical trial sites (initiation through close-out). The role requires minimum 1 year of independent CRA monitoring experience in Australia or New Zealand and involves site management, ensuring ICH-GCP and regulatory compliance, TMF/document management, use of CTMS/EDC/EDMS/IVRS/SIS systems, SAE and CRF follow-up, site training, and frequent travel. Degree or equivalent health/nursing qualification preferred.

The LSAD is responsible for leading Local Study Team(s) at country level to ensure timely delivery of clinical study commitments per ICH-GCP and client procedures. Duties include site identification/qualification, monitoring oversight, CTMS/eTMF management, regulatory and ethics submissions, budgeting and payments, risk management, and supporting audits/inspections. Role requires oncology experience, minimum 3 years in development operations or related fields, proficiency in English, a relevant bachelor's degree, and ability to travel nationally and internationally.

Role involves leading the site contracting lifecycle (strategy, execution, monitoring, risk mitigation), mentoring a site contracts team, collaborating with sponsors, CROs and internal stakeholders, managing budgets and forecasting, and developing project setup documents. Requires 3–5 years' experience in site contracting within the CRO industry and a bachelor's degree or equivalent.