Parexel

Compliance

• Provide regulatory strategy input for small molecule and biologic products
• Support regulatory leads in developing contingency plans for CMC-related scenarios
• Represent CMC Regulatory Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global regulatory leads
• Prepare, coordinate, and review CMC and GMP-related documents for regulatory submissions
• Develop CMC strategies for products across all phases—from early development to marketing applications and post-approval changes
• Partner with manufacturing, quality, and external organizations to address CMC-related issues
• Maintain collaborative relationships with internal stakeholders, affiliates, contract manufacturers, packagers, and suppliers
• Support planning and execution of Health Authority meetings, including mock sessions
• Identify and implement process improvements to enhance regulatory efficiency and readiness
• Participate in monthly CMC Global Regulatory Team meetings to align strategies across functions
• Ensure audit readiness and version control through meticulous documentation and system management

Senior Regulatory Affairs Consultant – Small Molecules and Biologics

Research Analyst

• Oversight of Monitoring Responsibilities and Study Conduct
• Ensuring regulatory, ICH-GCP and protocol compliance.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject as required.
• Manages reporting of protocol deviations and appropriate follow up.
• Documents activities via follow up letters, monitoring reports, communication logs, and other required project documents as per SOPs and CMP and SMP.

Senior Clinical Research Associate – Oncology

Procurement

• Lead Procurement team and fully support the business by providing a customer-focused, effective and responsive service.
• Oversee the management of supplier contracts and agreements, leading a team of buyers and senior buyers in all aspects of contract lifecycle management.
• Develop negotiation strategies to deliver against business objectives and achieve sustainable relationships with suppliers.
• Monitor and analyze local expenditures and supplier performance.
• Ensure team members effectively manage their assigned contract portfolios and maintain compliance with contractual obligations.

Manager, Global Procurement Operations

Software Engineer

• Provide technical expertise for the conduct of clinical trials
• Use SAS programming to produce derived datasets, tables, figures, and data listings
• Deliver best value and high-quality service working on client system
• Work closely with client teams and Parexel colleagues in a global environment
• Develop and QC derived dataset specifications and other process supporting documents
• Ensure all work maintains complete traceability and regulatory compliance
• Participate and contribute to knowledge-sharing sessions with programming community

Statistical Programmer II

Operations

• Support Payment / Procurement and Finance Processes
• QC Reagents and Materials Procurement & Logistics Support
• Vendor Management and Information Maintenance
• Contract Management
• Manage Systems / Accounts and Access Management
• Support Meeting and Event Administrative Coordination
• HR and Administrative Support
• Office Supplies and Daily Administration

RA Ops Specialist

Clinical Research

• Manage external vendors and contract research organizations
• Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, and Laboratory Manual
• Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards, and source documents
• Assist with protocol development and study report completion
• Manage monitoring activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols
• Provide guidance, direction, and management to CRAs
• Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports
• Coordinate study supplies
• Negotiate contracts with vendors of clinical trial services
• Review Informed Consent Forms, CRFs, and study-related materials
• Plan and participate in investigator meetings
• Assist and support the data query process
• Assure regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines
• Ensure trial master file is current and maintained
• Collaborate in the management of external vendors and contract research organizations to ensure efficient execution of clinical trials

Junior Clinical Trial Manager

ServiceNow

• Designing, developing, configuring, and maintaining the ServiceNow platform to support business processes across the organization
• Building and customizing applications, workflows, business rules, UI policies, client scripts, and integrations
• Developing and maintaining REST/SOAP integrations with external systems
• Creating and enhancing catalog items, record producers, and automation workflows
• Assisting in day ‑ to ‑ day administration of the ServiceNow platform, including user management, roles, groups, ACLs, and data integrity
• Implementing custom UI pages, dashboards, and reporting solutions
• Enforcing governance, best practices, and compliance with organizational standards
• Applying platform upgrades, patches, and hotfixes while ensuring minimal disruption
• Working closely with stakeholders to gather requirements and translate them into technical solutions
• Participating in Agile ceremonies, sprint planning, and backlog refinement
• Providing technical guidance, documentation, and knowledge transfer to internal teams

ServiceNow Developer

• Ensuring compliance with Health Authority drug promotion and promotional labeling regulations
• Reviewing, approving, or rejecting promotional programming
• Collaborating with Commercial Operations Marketing, Legal, and Medical personnel
• Monitoring and applying trends in regulation of advertising and promotional labeling
• Providing regulatory leadership and guidance to marketing teams
• Preparing and submitting advertising and promotional labeling materials to Health Authorities

Regulatory Affairs Consultant – Advertising & Promotional Labeling

Clinical Operations

• Responsible for performance and compliance for assigned protocols.
• Manages country deliverables, timelines, and results for assigned protocols.
• Oversees Clinical Trial Coordinators as applicable.
• Coordinates and liaises with Clinical Research Managers, Clinical Research Associates, and more.
• Develops local language materials including local language Informed Consents and translations.
• Influences investigators, external partners, and country operations to adhere to budget targets.