Precision Medicine Group

Accounting Manager

• Oversee month-end close processes, inventory accounting, revenue recognition, and financial reporting
• Review journal entries and prepare complex general ledger entries as needed
• Review accounts payable spend and cash flow forecasts
• Review balance sheet account reconciliations across multiple business units, including inventory, revenue, payroll liabilities, capitalized labor, ROU assets, fixed assets, intercompany accounts, and prepaids
• Partner with FP&A on budgets, forecasts, and allocation methods
• Train and mentor staff and ensure documentation of accounting thresholds, adjustments, and new GAAP standards
• Identify process improvement opportunities and support business acquisitions and new projects
• Monitor emerging US GAAP standards and assist with implementation
• Review financial results for efficiencies and establish internal controls to reduce payment errors, duplicate payments, and fraud
• Review customer contracts for consistent revenue recognition under US GAAP ASC 606
• Prepare and review audit support, accounting memos, audit schedules, and statutory audit materials
• Manage PBC requests and follow up on audit issues
• Assist with strategic initiatives including system implementations, integrations, and acquisitions
• Perform other duties assigned by the line manager

Manager

• Develop client-focused budgets and proposals for Phase I–IV clinical trials
• Prepare budgets, proposal text and re-bids for global RFP responses
• Coordinate the complete RFP preparation process with operational review leads
• Review client RFP documents and identify service requirements and assumptions
• Lead RFP development meetings with sales, operational review and finance teams
• Develop project budgets using costing tool templates and Excel-based formulas
• Prepare proposal text using departmental templates
• Coordinate with partners and third-party vendors during RFP development
• Perform quality control of budget and proposal text edits
• Support work orders and requests for information
• Respond to client questions regarding budgets and operational strategy
• Participate in client meetings as needed
• Maintain departmental records and internal and intercompany reporting
• Participate in departmental initiatives and perform other duties as needed

Proposals Manager – Senior

Supervisor

• Lead content development for multiple projects and provide input on strategy
• Independently develop strategic, high-quality, and medically accurate content for medical communications resources across multiple therapeutic areas
• Collaborate with internal team members to create content meeting client objectives
• Review project briefs and timelines, assign staff, and attend kick-off meetings
• Review content for scientific accuracy and project appropriateness
• Ensure content development best practices and advise on strategic or client considerations
• Liaise directly with clients on strategy and content-related medical, legal, and regulatory matters
• Discuss medical content with medical professionals, key opinion leaders, and managed care customers
• Plan and allocate resources with internal stakeholders
• Supervise 2–4 medical writers and/or scientific associates
• Establish and track individual development plans and provide timely feedback
• Assist with new business proposals, target product profiles, and competitive analyses
• Attend and present at business pitch meetings
• Promote and adhere to Precision Principles

Group Copy Supervisor, Market Access

Clinical Research

• Monitor and own the progress of clinical studies at investigative sites
• Ensure clinical studies are conducted, recorded, and reported according to protocol, SOPs, ICH-GCP, and applicable regulations and standards
• Coordinate activities required to set up and monitor studies
• Identify investigators
• Help prepare regulatory submissions
• Conduct pre-study and initiation visits
• Handle appropriately sized clinical trials
• Support larger clinical study teams
• Train and mentor junior staff members
• Interact directly with clients
• Initiate payments
• Participate in proposal activities, including development and client presentations

Senior Clinical Research Associate

• Monitor and own the progress of clinical studies at investigative sites
• Ensure clinical studies are conducted, recorded, and reported according to protocol, SOPs, ICH-GCP, applicable regulations, and standards
• Coordinate activities required to set up and monitor studies
• Identify investigators
• Help prepare regulatory submissions
• Conduct pre-study and initiation visits
• Handle appropriately sized clinical trials
• Support clinical study teams on larger-scope trials
• Train and mentor junior staff members
• Interact directly with clients
• Initiate payments
• Participate in proposal activities, including development and client presentations

• Monitor and own the progress of clinical studies at investigative sites
• Ensure clinical studies are conducted, recorded, and reported according to protocol, SOPs, ICH-GCP, and applicable regulations and standards
• Coordinate activities required to set up and monitor studies, including identifying investigators, helping prepare regulatory submissions, and conducting pre-study and initiation visits
• Handle appropriately sized clinical trials
• Support larger clinical study teams
• Train and mentor junior staff members
• Interact directly with clients
• Initiate payments
• Participate in proposal activities, including development and client presentations

• Monitor and own the progress of clinical studies at investigative sites
• Ensure clinical studies are conducted, recorded, and reported according to protocol, SOPs, ICH-GCP, and applicable regulations and standards
• Coordinate study setup and monitoring activities, including identifying investigators, helping prepare regulatory submissions, and conducting pre-study and initiation visits
• Handle appropriately sized clinical trials
• Support larger-scope clinical study teams
• Train and mentor junior staff members
• Interact directly with clients
• Initiate payments
• Participate in proposal activities, including development and client presentations

• Monitor and own the progress of clinical studies at investigative sites
• Ensure studies are conducted, recorded, and reported according to protocol, SOPs, ICH-GCP, applicable regulations and standards
• Coordinate study setup and monitoring activities, including investigator identification, regulatory submissions, pre-study visits and initiation visits
• Handle appropriately sized clinical trials
• Support larger clinical study teams
• Train and mentor junior staff members
• Interact directly with clients
• Initiate payments
• Participate in proposal activities, including development and client presentations

Financial Planning and Analysis

• Assist with monthly project accounting, including taking notes from status meetings and updating financial trackers
• Set up new projects in time and expense systems and files, verify signatures, reconcile with Salesforce, and escalate discrepancies
• Update project files for change orders, budget adjustments, carve-outs, milestones, and tasks
• Book intercompany revenue and cost transactions and update shared financial trackers
• Assist with preparing and investigating project hours and expenses, including reviewing billing roles and rates
• Prepare client invoices based on contracts and follow up on past-due invoices
• Create and maintain invoicing waterfalls when applicable
• Assist with monthly client accruals
• Track project costs against contracted amounts and shared direct costs
• Set up and track employee and subcontractor hours, bill rates, and expenses against forecasts and budgets
• Update routine monthly general ledger reconciliations and collaborate with the SG&A team
• Assist with ad hoc projects, including annual budget preparation
• Assist in preparing supporting documents for the annual audit

Client Finance Analyst

Compliance

• Provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures
• 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/or review submission documents to ensure compliance with regulatory standards
• Represent Global Regulatory Affairs at project team meetings with external and internal customers
• Work within project teams and lead regional or global projects where necessary
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets
• Maintain project plans, project trackers, and regulatory intelligence tools; keep Regulatory Leadership updated
• Assist in developing Regulatory Affairs Specialists and other operational staff
• Contribute to 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 drug development laws, regulations, and guidelines
• Provide ICH GCP guidance, advice, and training to internal and external clients
• Represent Global Regulatory Affairs at business development meetings

Regulatory Manager / Senior Regulatory Manager

• Provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures
• 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/or review submission documents for regulatory compliance
• Represent Global Regulatory Affairs at internal and external project team meetings
• 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
• Contribute to regulatory strategy and timeline development for new study opportunities
• Help establish company standards for high-quality submitted information
• Participate in corporate quality initiatives across Clinical Solutions business units
• Maintain knowledge of laws, regulations, and guidelines governing drug development and approval
• Provide ICH GCP guidance, advice, and training to internal and external clients
• Represent Global Regulatory Affairs at business development meetings

• Provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures
• Coordinate and prepare regulatory documents for submission to Regulatory Authorities and 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 meeting materials, orphan designations, paediatric planning documents, and marketing applications
• Provide strategic regulatory input as required
• Develop and review submission documents to ensure compliance with regulatory standards
• Represent Global Regulatory Affairs at project team meetings with external and internal 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; keep Regulatory Leadership updated
• Assist in developing Regulatory Affairs Specialists and other operational staff
• Contribute to regulatory strategy and timeline development for new study opportunities
• Assist in establishing company standards for high-quality submitted information
• Maintain and execute 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
• Represent Global Regulatory Affairs at business development meetings

Regulatory Manager – Senior Regulatory Manager

• Provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures
• Ensure timely preparation of well-organised, quality regulatory submissions compliant with applicable regulations
• Coordinate and prepare regulatory documents for Regulatory Authorities and Ethics Committees
• Provide regulatory guidance throughout the clinical development life cycle
• Compile, coordinate, and review CTA/IND applications, annual reports, routine amendments, scientific advice and regulatory authority meeting materials, orphan designations, paediatric planning, and marketing applications
• Provide strategic regulatory input as required
• Develop and review submission documents for Regulatory Authorities and Ethics Committees
• Represent Global Regulatory Affairs at project team meetings with external and internal 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, project 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
• Maintain and execute corporate quality initiatives across Clinical Solutions business units
• Keep current with laws, regulations, and guidelines governing drug development and approval
• Provide ICH GCP guidance, advice, and training to internal and external clients
• Represent Global Regulatory Affairs at business development meetings

• Provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures
• Coordinate and prepare regulatory documents for submission to Regulatory Authorities and Ethics Committees
• Provide regulatory guidance throughout the clinical development life cycle
• Compile, coordinate, and review CTA/IND applications, annual reports, routine amendments, scientific advice and regulatory authority meeting materials, orphan designations, paediatric planning, and marketing applications
• Provide strategic regulatory input as required
• Develop and review submission documents for compliance with regulatory standards
• Represent Global Regulatory Affairs at project team meetings with external and internal 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
• Contribute to regulatory strategy and timeline development for new study opportunities
• Help establish company standards for high-quality submitted information
• Participate in corporate quality initiatives across Clinical Solutions business units
• Maintain current knowledge of laws, regulations, and guidelines governing drug development and approval
• Provide ICH GCP guidance, advice, and training to internal and external clients
• Represent Global Regulatory Affairs at business development meetings