Precision Medicine Group

Compliance

• Provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures
• Ensure timely preparation of organized, quality regulatory submissions in compliance with applicable regulations
• Coordinate and prepare regulatory documents for submission to Regulatory Authorities and/or Ethics Committees
• Provide regulatory guidance throughout the clinical development life cycle
• Compile, coordinate, and review CTA/IND applications, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications
• Develop and review documents for Regulatory Authorities and Ethics Committees
• Represent Global Regulatory Affairs at project team and business development meetings with internal and external customers
• Work within project teams and lead regional or global projects when necessary
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets
• Maintain project plans, trackers, and regulatory intelligence tools; update Regulatory Leadership
• Assist in developing Regulatory Affairs Specialists and other operational staff
• Provide input into regulatory strategy and timeline development for new study opportunities
• Assist in establishing company standards for high-quality submitted information
• Participate in corporate quality initiatives across Clinical Solutions business units
• Maintain and expand knowledge of laws, regulations, and guidelines governing drug development and approval
• Provide ICH GCP guidance, advice, and training to internal and external clients

Regulatory Manager – Senior Regulatory Manager

• Deliver timely and high-quality site activation readiness within assigned country/sites while identifying and mitigating risks
• Prepare Clinical Trial Application Forms and submission dossiers for Competent Authorities, Ethics Committees, IRBs, and other applicable local bodies
• Interact with Competent Authorities and Ethics Committees and handle responses
• Provide regular submission updates to Start Up/Regulatory Leads and Project Managers/Project Teams
• Maintain project plans, trackers, and regulatory intelligence tools
• Support study-specific start-up plans, IMP release requirements, and essential document review criteria
• Partner with assigned site CRAs to align communication and secure site collaboration
• Prepare, review, and manage essential documents required for site activation and IMP release
• Customize country/site-specific Patient Information Sheets and Informed Consent Forms
• Facilitate document translations and coordinate translation activities
• Coordinate with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams
• Act as subject matter expert for site-level critical path and Site Activation data points
• Support study budget negotiations and investigator contract execution when required
• Support feasibility site outreach when needed
• Maintain knowledge of local clinical trial laws and regulations and distribute knowledge within Precision for Medicine
• Maintain audit/inspection readiness and file documents according to TMF or study-specific plans
• Support Pre-Study Site Visits when needed
• Support process improvement initiatives, training, and mentoring
• Perform other duties assigned by management

Regulatory and Site Start-Up Specialist

Research Scientist

• Contribute to multiple projects comprised of cross-functional staff as the analytics expert
• Design real-world evidence studies
• Develop study protocols and analysis plans
• Perform analyses of primary and secondary data
• Communicate study results internally and externally
• Conduct data feasibility assessments, create analytic datasets, perform data analyses, and prepare study reports
• Present to and interact with clients across functions

Senior Research Scientist – Real World Evidence

Analyst

• Serve as content experts on assigned projects and contribute to the development and delivery of client outputs
• Apply analytical skills to derive meaningful insights and solve complex client problems
• Collaborate with senior consultants and global teams
• Independently procure information through secondary research using internal databases, published literature, payer/HTA websites, and industry sources
• Develop discussion guides, screeners, and stimuli for primary research with payers, KOLs, and patient groups
• Participate in and, when fully capable, independently conduct primary research interviews with global healthcare stakeholders
• Conduct desk-based research addressing key client questions
• Prepare client-ready presentations with clear analytical structure, strong storylines, and actionable insights
• Perform quantitative and qualitative analyses supporting recommendations on launch pricing, market access strategy, and value communication

Business Development Rep

• Develop and execute annual strategic business plans to drive new revenue and sales growth for Precision AQ products and services
• Build and maintain client relationships, especially with senior executives, to generate new business and revenue growth
• Manage client opportunities from prospecting through solution development, SOW finalization, and transition to Precision service lines for implementation
• Coordinate with service line leads and account management staff to advance cross-selling opportunities and expand market share within targeted accounts
• Engage life science clients through individual and group presentations to cultivate revenue opportunities
• Manage the client sales cycle, including prospecting, stakeholder meetings, proposal development and delivery, pipeline management, and transition to implementation
• Prepare executive summaries and presentations demonstrating the value of Precision AQ solutions
• Negotiate client deliverables and value-based pricing
• Maintain and update client records in Salesforce
• Communicate client needs, feedback, and recommendations to service lines
• Coordinate with Marketing and Sales Operations on strategic marketing and lead generation
• Promote Precision AQ capabilities through conferences, trade shows, and webinars
• Represent engagement resources and innovation at conferences and trade shows
• Direct market research and competitive analysis to identify trends and opportunities
• Contribute to pricing and competitive positioning
• Track competitors and analyze competitive threats
• Matrix manage and mentor extended team members
• Travel up to 50%

VP, Strategic Business Partner – Business Development

Account Executive

• Establish and cultivate day-to-day client relationships
• Present and defend the agency’s strategic and tactical recommendations
• Contribute to marketing strategy, communications plans, and media plans
• Foster positive working relationships between internal departments
• Guide Account Executives by communicating clear goals and providing timely feedback
• Supervise job budget preparation, approve internal budgets, and allocate hours to team members
• Develop understanding of clients’ objectives, initiatives, and target patient/professional audiences
• Ensure tactics are strategically executed
• Represent the account team with senior agency leadership

Senior Account Executive – Healthcare Advertising

Manager

• Review, draft, negotiate and track legal agreements, including confidentiality agreements, master services agreements, site contracts, consulting agreements, vendor agreements, clinical study agreements, amendments and other client contracts
• Work with supervisors and internal/external stakeholders to resolve or escalate contractual issues
• Ensure adherence to company policies, procedures and contracting standards
• Update study team members on contract negotiation and execution status
• Establish, track, report and manage site contract metrics
• Support maintenance and archiving of contract files and databases
• Assist in designing and implementing procedures for timely contract execution
• Identify process improvement opportunities and take corrective action
• Work closely with Clinical Operations study teams to align deliverables with study timelines
• Perform other assigned tasks

Site Contracts Manager

• Review, draft, negotiate and track legal agreements, including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendment agreements
• Collaborate with Clinical Operations study teams to align deliverables with study timelines
• Review, draft and negotiate master services agreements, site contracts, consulting agreements, vendor agreements, confidentiality agreements and other client contracts
• Work with supervisors and internal/external stakeholders to resolve or escalate contractual issues
• Ensure adherence to company policies, procedures and contracting standards
• Update study team members on contract negotiation and execution status
• Establish, track, report and manage site contract metrics
• Maintain contract files and databases, including contract archiving
• Assist in designing and implementing procedures for timely contract execution
• Identify process improvements and take corrective action
• Perform other assigned tasks

• Review, draft, negotiate, and track legal agreements, including confidentiality agreements, master confidentiality agreements, clinical study agreements, amendment agreements, master services agreements, site contracts, consulting agreements, vendor agreements, and other client contracts
• Work with supervisors and internal/external stakeholders to resolve or escalate contractual issues
• Ensure adherence to company policies, procedures, and contracting standards
• Update study team members on contract negotiation and execution status
• Establish, track, report, and manage site contract metrics
• Support maintenance of contract files and databases, including contract archiving
• Assist in designing and implementing policies and procedures for timely contract execution
• Identify process improvements and take corrective action
• Perform other assigned tasks

• Review, draft, negotiate and track legal agreements, including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments
• Review, draft and negotiate master services agreements, site contracts, consulting agreements, vendor agreements, confidentiality agreements and other client contracts
• Work with supervisors and internal/external stakeholders to resolve or escalate contractual issues
• Ensure adherence to company policies, procedures and contracting standards
• Update study team members on contract negotiation and execution status
• Establish, track, report and manage site contract metrics
• Support maintenance and archiving of contract files and databases
• Assist in designing and implementing procedures for timely contract execution
• Identify process improvements and take corrective action
• Collaborate with Clinical Operations study teams to align deliverables with study timelines
• Perform other assigned tasks

• Review, draft, negotiate and track confidentiality agreements, master confidentiality agreements, clinical study agreements and amendment agreements
• Review, draft and negotiate master services agreements, site contracts, consulting agreements, vendor agreements, confidentiality agreements and other client contracts
• Work with supervisors and internal/external stakeholders to resolve or escalate contractual issues
• Ensure adherence to company policies, procedures and contracting standards
• Update study team members on contract negotiation and execution status
• Establish, track, report and manage site contract metrics
• Maintain contract files and databases, including contract archiving
• Assist in designing and implementing policies and procedures for timely contract execution
• Identify process improvements and take corrective action
• Collaborate with Clinical Operations study teams to align deliverables with study timelines

• Review, draft, negotiate and track confidentiality agreements, master confidentiality agreements, clinical study agreements and amendment agreements
• Review, draft and negotiate master services agreements, site contracts, consulting agreements, vendor agreements, confidentiality agreements and other client contracts
• Work with supervisors and internal/external stakeholders to resolve or escalate contractual issues
• Ensure adherence to company policies, procedures and contracting standards
• Update study team members on contract negotiation and execution status
• Establish, track, report and manage site contract metrics
• Support maintenance, archiving and organization of contract files and databases
• Assist in designing and implementing procedures for timely contract execution
• Identify process improvements and take corrective action
• Work closely with Clinical Operations study teams to align deliverables with study timelines