Syneos Health

Compliance

• Execute commercial Lifecycle Management (LCM) strategy and submissions with a focus on US/CA/EU
• Review CMC sections of regulatory submissions, interactions, and responses with regulatory agencies
• Work with regulatory colleagues to develop global regulatory CMC strategies and submissions
• Participate effectively on cross-functional teams
• Serve as the primary regulatory CMC contact for assigned products and projects

Senior Regulatory CMC Consultant – Small Molecule, Veeva RIM

Analyst

• Support Learning Center operations for clinical teams, internal employees, and external clients
• Manage and optimize SharePoint environments
• Support training-related activities, including system access, documentation, and compliance tracking
• Design and maintain SharePoint-based solutions independently
• Assist with organizational projects and initiatives, including training, system deployments or enhancements, process development and documentation, validation/testing, and data migrations
• Participate in process improvements and assist with business redesign
• Monitor operational indicators, identify and escalate critical business issues
• Apply critical thinking and problem-solving to analyze impacts, communicate findings, and resolve issues
• Extract data from systems or applications
• Analyze operational metrics to identify exceptions, erroneous data, gaps, trends, and improvement opportunities
• Communicate metric findings
• Respond to end-user questions and requests with guidance or resolution
• Identify and appropriately route issues for escalation
• Document support issues to ensure resolution
• Assist with preparing and maintaining end-user training materials and job aids

Bus Process and Performance Analyst

Safety Specialist

• Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs
• Assist in processing ICSRs according to SOPs and project/program-specific safety plans
• Triage ICSRs and evaluate data for completeness, accuracy, and regulatory reportability
• Enter data into safety databases
• Code events, medical history, concomitant medications, and tests
• Compile complete narrative summaries
• Identify information to be queried and follow up until queries are satisfactorily resolved
• Assist with timely and accurate expedited safety reporting
• Maintain safety tracking for assigned activities
• Perform literature screening and review for safety
• Perform drug coding and maintain drug dictionaries and MedDRA coding
• Validate and submit xEVMPD product records, including coding indication terms using MedDRA
• Manually recode un-recoded product and substance terms from ICSRs
• Identify and manage duplicate ICSRs
• Perform activities related to SPOR/IDMP
• Conduct quality review of ICSRs
• Submit relevant documents to the Trial Master File and Pharmacovigilance System Master File
• Maintain compliance with SOPs, WIs, drug/biologic/device regulations, GCP, ICH guidelines, GVP, project plans, and the drug development process
• Foster professional working relationships with project team members
• Participate in audits
• Apply safety reporting regulatory intelligence to safety reporting activities

Safety & PV Specialist – Future Roles

Software Engineer

• Use SAS or other software to develop custom programming code for summary tables, data listings, graphs, and derived datasets
• Ensure outputs meet quality standards and project requirements
• Perform validation programming and resolve discrepancies with programmers, biostatisticians, and project team members
• Keep project team members informed of programming progress and issues
• Follow applicable SOPs, WIs, and relevant regulatory guidelines such as ICH
• Maintain complete, current project documentation, testing, verification, and quality-control materials
• Manage schedules and priorities across multiple projects
• Develop specifications for datasets and outputs according to statistical and sponsor requirements
• Anticipate and address programming issues and define variables for peer review and sponsor/requestor approval
• Prepare for and conduct internal meetings, distribute information and minutes, and follow action items to completion
• Negotiate time estimates and complete study programming activities within allotted timelines
• Act as lead statistical programmer and direct other programming personnel
• Monitor programming deliverables and review study documentation including SAPs, mock shells, programming specifications, annotated CRFs, and SAS database designs
• Participate in sponsor, kickoff, and bid defense meetings as the statistical programming representative
• Mentor programming personnel through training, work reviews, feedback, and guidance
• Transfer deliverables and perform other assigned work-related duties

Senior Statistical Programmer

Nurse

• Remain fully conversant with the trial protocol, Case Report Forms (CRFs/eCRF), off-site manual, supporting documents, procedures, timelines, and relevant SOPs
• Communicate with the Illingworth research nurse project manager, Research nurse manager, site staff, and Principal Investigator
• Maintain accurate documentation and electronic data transfers while ensuring subject confidentiality, GCP, and data protection compliance
• Attend Site Initiation Visits and other required meetings
• Coordinate and complete on-site and off-site subject trial visits with the RN team
• Complete trial procedures and assessments according to protocol and SOPs and collect accurate data
• Administer trial medication and facilitate its safe storage, transfer, and accountability
• Process, safely package, and dispatch samples while liaising with courier companies and organizations
• Assist with identifying eligible patients and patient recruitment, providing information and support for on-site and off-site care
• Accurately report adverse events, serious adverse events, and suspected unexpected serious adverse reactions
• Report suspected misconduct or fraud to Illingworth and associated companies

Research Nurse – Per Diem

Medical writer

• Lead the clear and accurate completion of medical writing deliverables
• Manage medical writing activities for individual studies with minimal supervision
• Coordinate medical writing activities within and across departments
• Lead resolution of client comments
• Complete clinical study protocols, protocol amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and presentations
• Adhere to ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style and formatting guides
• Coordinate quality and editorial reviews and manage source documentation
• Lead team document reviews and act as a peer reviewer
• Review statistical analysis plans and table/figure/listing specifications
• Collaborate with clients and data management, biostatistics, regulatory affairs, and medical affairs teams
• Perform online clinical literature searches and comply with copyright requirements
• Identify and resolve issues, escalating as appropriate
• Provide technical support, training, and consultation
• Contribute to internal materials, presentations, processes, standards, and capabilities
• Mentor and lead less experienced medical writers on complex projects
• Develop expertise in industry topics and regulatory requirements
• Monitor budgeted hours and communicate status and changes to medical writing leadership
• Complete administrative tasks and other assigned duties

Senior Medical Writer – Sponsor Dedicated, CSR, Protocols, IB, Reg Documents

Contracts Specialist

• Negotiate, draft, review, and finalize Clinical Trial Agreements (CTAs) and other site-related contracts for clinical research studies
• Lead contract negotiations with investigative sites, hospitals, academic institutions, site networks, and healthcare systems
• Review legal and commercial terms, including confidentiality, indemnification, insurance, intellectual property, publication rights, and payment provisions
• Negotiate site budgets and payment schedules with study teams and site representatives
• Identify contractual risks and propose solutions aligned with company and sponsor requirements
• Manage contract amendments resulting from protocol changes, study extensions, enrollment adjustments, or budget updates
• Serve as the primary point of contact for site contract communications with sponsors, sites, legal counsel, and internal stakeholders
• Mentor, lead, and motivate more junior staff
• Provide quality feedback and guidance to peers
• Contribute to training and Quality assurance plans within SSU and update SOPs/WI

Site Contracts Specialist – Senior

Product Marketing

• Own MarTech products across discovery, business-case development, roadmap prioritization, delivery, adoption and value realization
• Define product vision, strategy and roadmap based on business, customer and user needs
• Translate and prioritize business needs into product requirements, user stories, technical requirements and measurable outcomes
• Prioritize product features and manage the backlog in partnership with engineering, data, UX and technology teams
• Develop solutions supporting B2B marketing and demand generation, including ABM, lead capture, nurturing, scoring, routing, campaign management and attribution
• Drive integrations across marketing platforms, Salesforce CRM, websites, customer data platforms, analytics tools and third-party data providers
• Define and track KPIs including adoption, funnel performance, lead-to-opportunity conversion, attribution, pipeline contribution and business value
• Partner across Marketing, Sales, Technology, Data, Privacy, Security and Compliance to deliver scalable solutions
• Evaluate and introduce AI-enabled marketing capabilities where they deliver measurable value
• Manage vendors, implementation partners, contracts and platform evaluations
• Lead change-management activities including communication, training, adoption and feedback management
• Communicate product recommendations, priorities, technical concepts and trade-offs to technical and non-technical stakeholders and executives
• Mentor and coach junior team members and build internal and external partnerships

Marketing Product Manager, Salesforce

General Counsel

• Serve as a trusted legal advisor to Human Resources and business leaders throughout Italy and designated EMEA jurisdictions
• Provide day-to-day legal advice on employment law, employee relations, performance management, disciplinary actions, accommodations, leaves of absence, workplace conduct concerns, and separations
• Advise on workforce restructurings, reorganizations, reductions in force, outsourcing initiatives, and business transformation projects
• Support labor relations matters involving employee representative bodies, works councils, collective consultation requirements, and union-related issues
• Draft, review, and update employment-related agreements, policies, handbooks, procedures, templates, and guidance materials
• Monitor and advise on employment legislation and regulatory requirements
• Prepare and provide employment law training for Human Resources, managers, and business stakeholders
• Manage employment litigation, administrative proceedings, employee claims, labor disputes, agency charges, and pre-litigation matters
• Conduct legal risk assessments and recommend dispute resolution strategies
• Coordinate and manage external counsel
• Support internal investigations involving employee misconduct, discrimination, harassment, retaliation, ethics concerns, and other workplace matters
• Assist with responses to government agencies, labor authorities, regulators, and third-party inquiries
• Provide reporting and strategic updates on legal matters, litigation trends, and risk areas
• Draft, review, negotiate, and advise on commercial agreements supporting EMEA business needs
• Partner with Procurement, Finance, Compliance, Privacy, HR, Business Technology, Quality, and operational stakeholders
• Advise on contract, vendor, customer, and operational risks and disputes
• Support standard forms, contracting processes, policies, playbooks, and legal workflows
• Support corporate due diligence, integration activities, and cross-functional legal projects
• Support corporate compliance initiatives and governance activities throughout the region
• Collaborate with Legal, Compliance, Privacy, Human Resources, and business teams to identify and mitigate legal and regulatory risk
• Assist in developing, implementing, and maintaining legal policies, procedures, and best practices
• Work collaboratively across the Legal department with regional attorneys and global subject-matter experts
• Support the Syneos Health Mission, Vision, and Values
• Perform other work-related duties as assigned

Associate Counsel, Italy – Fixed-term

Product Manager

• Own product vision, strategy, multiyear roadmap, business cases, and investment priorities for sales technology capabilities aligned with sales-growth objectives
• Translate seller and business needs into scalable product capabilities, technical and analytical requirements, user stories, acceptance criteria, and measurable success metrics
• Lead products through discovery, user research, design, Agile delivery, quality assurance, launch, adoption, measurement, iteration, and continuous improvement
• Partner with Sales, Sales Operations, Marketing, Data, Technology, Privacy, Security, Compliance, engineering teams, and external clients
• Own or guide enterprise CRM and adjacent sales technologies, including integrations, APIs, data models, analytics, workflow automation, and AI-enabled capabilities
• Use customer research, usage data, experimentation, and sales-performance metrics to prioritize investments and make product tradeoffs
• Define requirements, statements of work, scope, estimates, timelines, supplier plans, and implementation approaches
• Evaluate platform configuration, purchased solutions, and custom-built capabilities
• Manage implementation partners, software vendors, platform evaluations, budgets, contracts, and total cost of ownership
• Lead stakeholder communication and expectation management
• Drive launch readiness, training, communications, adoption, feedback loops, and change management
• Coach junior product managers or business analysts where applicable

Senior Product Manager – Sales Products

Director

• Manage Product Managers and UX Designers across onshore and offshore teams, including line management, performance management, professional development, interviewing, and onboarding
• Own a discipline within the department and manage a global team
• Lead creation of the overall product vision and roadmap with leadership
• Establish product strategy and roadmap across proposal, pricing, and contracting technologies while owning one or more complex products
• Translate and prioritize business needs into technical and analytical requirements, product requirements, user stories, and measurable outcomes
• Oversee prioritization of product features, modifications, attributes, and backlogs, and communicate priorities to development teams
• Partner with data scientists and engineers on requirements, statements of work, budget estimates, scope, timelines, and supplier line-ups
• Identify unresolved business needs with internal and external clients and use them to guide product strategy
• Drive product strategy, discovery, business-case development, delivery, adoption, and value realization
• Lead process standardization and technology adoption across businesses, functions, and geographies
• Manage vendors, implementation partners, budgets, contracts, and product evaluations
• Build relationships across Sales, Proposal Management, Pricing, Legal, Finance, Operations, Data, Technology, and external partners
• Coach and develop Product Managers, set objectives, review roadmaps, delegate effectively, and establish consistent product-management standards
• Communicate technical concepts to non-technical clients and stakeholders and facilitate collaboration across teams

Associate Director – Deal Management Products, Salesforce/Oracle APEX

Physician

• Perform medical review of adverse events for investigational and marketed products
• Apply medical interpretation and consistency to adverse event case assessment with Safety and Pharmacovigilance colleagues
• Ensure regulatory and SOP compliance for evaluation, reporting, and surveillance of safety information
• Identify, communicate, and manage potential safety issues
• Interact with client safety and medical personnel
• Stay current on clinical and drug development information relevant to contracted programs
• Provide medical review and interpretation for aggregate safety reports, including annual safety reports, PSURs, and PADERs
• Maintain medical and pharmacovigilance expertise through continued medical education
• Mentor and train internal safety staff, including case processing staff
• Perform activities in compliance with corporate and departmental policies, SOPs, work instructions, and project-specific operating guidelines
• Perform other duties assigned by management

Safety Physician

French

• Responsible for country-level quality deliverables and compliance with project requirements and applicable country rules
• Track submission and approval milestones in the SSU tracking system and investigate or escalate timeline delays
• Monitor basic project financial aspects and contracted hours/tasks
• Review and comply with SOPs and Work Instructions and maintain training records and timesheet compliance
• Support quality improvement across Site Start-Up components, including submissions, essential document collection, and communication with Competent Authorities and Ethics Committees
• Ensure relevant documents are submitted to the Trial Master File
• Prepare and submit Central and Local Ethics Committee applications, Regulatory Authority applications, and other local regulatory or hospital approval submissions
• Prepare ongoing submissions, amendments, periodic notifications, and safety notifications as required
• Liaise between investigational sites and functional leads and oversee the end-to-end site activation process
• Provide country-level regulatory intelligence and support data protection guidance
• Provide input to local SOPs, Work Instructions, and internal training materials
• Support Ethics Committee or Competent Authority issue resolution
• Support site selection and feasibility activities
• May support investigator contract and budget negotiation, contract preparation, quality control, execution, archival, and metadata capture

Site Activation Specialist, French Speaker

• Remain fully conversant with the trial protocol, Case Report Forms (CRFs/eCRF), off-site manual, supporting documents, procedures, timelines, and relevant SOPs
• Communicate with the Illingworth research nurse project manager, Research nurse manager, site staff, and Principal Investigator
• Maintain accurate documentation and electronic data transfers while ensuring subject confidentiality, GCP, and data protection compliance
• Attend Site Initiation Visits and other required meetings
• Coordinate and complete subject trial visits on- and off-site with the RN team
• Complete trial procedures and assessments according to protocol and SOPs and collect accurate data
• Administer trial medication and facilitate its safe storage, transfer, and accountability
• Process, package, and dispatch samples while liaising with courier companies and organizations
• Assist with identifying eligible patients and patient recruitment into clinical trials
• Provide patient information and support for on- and off-site care
• Report adverse events, serious adverse events, and SUSARs to the site team and RNPM
• Report suspected misconduct or fraud to Illingworth and associated companies

Part Time Research Nurse

Clinical Research

• Review assigned protocols and study documentation for accuracy, feasibility, timing, and resources
• Prepare and maintain Investigator Site Files and/or Trial Master Files
• Participate in timelines, start-up meetings, and sponsor discussions
• Coordinate study start-up activities, clinic logistics, training, source documents, CRFs, laboratory workbooks, staffing, schedules, safety assessments, quality control, monitoring plans, pharmacy requirements, supplies, and regulatory documentation
• Support the Principal Investigator with delegation logs, daily tasks, visit calendars, monitor visits, and participant recruitment and screening
• Perform study activities according to Good Clinical Practices
• Manage multiple clinical trials simultaneously and protect participant safety
• Collect and enter study data, complete Case Report Forms, submit data, and facilitate audits
• Coordinate screening and informed consent activities
• Supervise clinic visits, provide on-call support, screen eligibility, and oversee or perform study drug administration as delegated
• Monitor study activities for compliance with protocol, SOPs, and applicable regulations
• Manage clinic updates, adverse event and serious adverse event reporting, study logs, trackers, quality control, and monitor findings
• Coordinate resolution of QC, monitor, CRF, and other findings
• Oversee study close-out documentation, deviations, CRF completion, TMF updates, logs, supplies return, IRB reports, and archiving
• Monitor participant compliance and escalate trial or study issues
• Prepare for and participate in sponsor, monitor, and QA audits
• Provide timely project status updates to Project Managers and sponsors
• Collaborate on process improvement, SOP creation/revision, meetings, and company initiatives
• Coordinate regulatory activities, including protocol, consent, amendment, and yearly renewal submissions
• Report trial-related adverse events and maintain study files
• Perform other assigned work-related duties
• Travel up to 100%