Precision Medicine Group

Medical writer

• Serving as medical point person on assigned accounts
• Developing, writing and translating complex scientific data to a broad audience across multiple and wide-ranging therapeutic areas
• Ensuring project quality and outcomes by demonstrating in depth technical expertise of assigned therapeutic category and/or managed care areas
• Developing strategic content for full range of medical content (slide presentations, advisory boards, strategy guides, monographs, discussion guides, training resources, etc.)
• Working closely with account teams to refine content in keeping with strategic imperatives
• Communicating medical content with internal team and pharmaceutical clients, as necessary
• Attending medical, legal, regulatory review meetings
• Participating in internal team meetings, including project kick-off meetings, weekly status meetings, client meetings, and internal brainstorm/review meetings
• Chipping in ideas for new business proposals and tactical planning within assigned accounts
• Mentoring junior level writers

Senior Scientific Associate – Senior Medical Writer, Promotional Medical Writing

• The Medical Writer is responsible for developing and writing content for their assigned account(s)
• Develop high quality, medically accurate content in print or digital format for a wide range of medical communication resources
• Deliver requested projects per established timelines
• Conduct literature reviews and develop annotations to support promotional claims in a variety of promotional medical education and marketing resources
• Ensure professional, proactive, and collaborative communication with internal and external stakeholders
• Work closely with account teams to refine content in keeping with strategic imperatives
• Attend medical, legal, regulatory review meetings, as necessary
• Participate in all internal team meetings, including project kick-off meetings, weekly status meetings, client meetings, and internal brainstorm/review meetings
• Contribute ideas for tactical planning within assigned accounts
• Promote and adhere to Precision Value and Health’s workplace values known as PRECISION Principles

Medical Writer – Promotional Medical Writing

Medical Director

• Independently develop strategic, high-quality, and medically accurate content for a wide range of medical communications resources
• Collaborate with internal team members to create compelling content that meets client objectives
• Review project briefs and timelines, assign staff, and attend all kick-off meetings
• Review content for scientific accuracy and appropriateness to the project
• Ensure best practices for content development are followed and advise on strategic or client considerations
• Liaise directly with client on strategy and content-related subject matter including medical, legal, regulatory review meetings
• Discuss medical content with external stakeholders including medical professionals, key opinion leaders, and managed care customers as required
• Plan and allocate resources based on business needs in conjunction with other internal stakeholders
• Supervise 2 – 4 medical writers and/or scientific associates directly
• Establish and track individual personal development plans for each team member and provide timely feedback
• Assist in development of new business proposals including target product profiles (TPPs) and/or competitive analyses
• Attend and present at business pitch meetings as needed
• Promote and adhere to Precision Value and Health’s workplace values known as PRECISION Principles

Medical Director – Market Access

Project Manager

• Manages and provides leadership to Directors, drives strategy to plan, coordinate, and deliver all activities for designated clinical study projects.
• Work with Senior Leadership to support defined corporate and departmental business strategies for Precision.
• Direct, manage and ensure collaboration within a team of Directors, Project Directors and Project Managers in the planning, execution and governance of projects/portfolios on a global platform.
• Provide leadership and oversight on all programs including large programs or programs that are increasingly complex (in scope, revenue contribution, volume and design).
• Interact with study sponsors as primary point of escalation beyond project management.
• Optimize the profitability of the Project Management organization to meet or exceed budget targets.
• Assess and manage resource allocations to ensure that established cost, time, and quality goals are met.
• Select, train, develop and manage the performance of talent in project leadership positions (Directors, Project Directors and Project Managers).
• Provide technical support and guidance (including scope definition, risk identification, escalation and mitigation, resource planning, goals and deliverables) to assigned project managers.
• Identify and escalate impacts to project scope, resources, schedule or budget through standard methods.
• Ensure project leadership personnel work to the highest quality standards and maintain compliance with established SOPs, working guidelines, project plans and all regulatory requirements.
• Participate with Business Development in opportunity development, proposals and budgeting, bid defense preparation and attendance.
• Understand and manage project/program inter-dependencies to achieve program milestones/deliverables.
• Conduct evaluations and implement required changes for all projects (including mid-project recovery of at risk projects, re-scoping, postponement, or cancellation).
• Measure and report KPIs and lead continuous improvement.
• Recognize, exemplify and adhere to Precision’s values that center on our commitment to quality, our people, clients and performance.
• May function as Executive Oversight for projects not assigned as DPM.

Executive Director, Project Management

AI Engineer

• Build and deploy enterprise-ready AI solutions using LLMs, other GenAI approaches, and deep learning capabilities.
• Scale out AI solutions: optimize performance of solutions, automate deployment and testing
• Rapidly prototype and iterate on AI applications using Azure, AWS, and off-the-shelf tools.
• Partner with the AI Solutions Architect to ensure scalable, secure, and compliant system design.
• Develop APIs and lightweight UIs (e.g., Dash, Flask and others) to deliver AI tools to end users.
• Stay current on emerging AI technologies, including vector databases, RAG pipelines, and productivity AI platforms.
• Drive delivery of AI components aligned with product roadmaps and business priorities.

QA Engineer

• Oversee the PFM risk-based Computer System Validation planning and execution (e.g., Validation Plans, Requirements Traceability Matrix, IQ/OQ/PQ, UAT), aligned to 21 CFR Part 11, EU Annex 11, ICH E6(R3) GCP, GLP, and data integrity principles (ALCOA++).
• Ensure all computerized systems are validated according to internal SOPs and regulatory expectations.
• Maintain a robust risk-based approach to system validation and lifecycle management by assuring periodic review, change control, configuration management, and release readiness for validated systems.
• Supports lifecycle controls from implementation through decommissioning.
• Establish and enforce QA policies and procedures for PFM systems. Provides input to the Application Development Lifecycle (ADLC) processes to represent regulated technologies
• Monitor compliance trends and implement continuous improvement initiatives.
• Serve as the primary key liaison with regulatory agencies and third parties for system-related audits and inspections.
• Supports the maintenance of inspection ready validation documentation
• Partner with Security, Development, PMO, BRM, Business Analysts, DevOps, Clinical Ops, and Lab leaders to prioritize QA activities and embed quality into SDLC/DevOps pipelines
• Act as a key liaison with regulatory agencies during inspections related to corporate systems.
• Deliver training and coaching on validation, testing, and data integrity for system owners and study teams
• Partake to the qualification of data/system service providers
• Ensure accurate and timely documentation of validation activities, deviations, and corrective actions.
• Provide regular compliance reports and metrics to senior leadership.
• Maintain audit readiness for all corporate systems.
• Collaboratively work with IT to respond to audit findings.

Director, Quality Assurance – Systems

Research Analyst

• Oversees, with supervision, all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• Supports site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Conducts all forms of site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits with different levels of supervision as required, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
• Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs, with different levels of supervision as required, investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies.
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Clinical Research Associate I

Clinical Research

• Management and operational delivery of the clinical elements within a trial including site selection, start-up, enrolment management, site engagement and support, monitoring planning and execution, data cleaning activities and close-out
• Successful execution of assigned trials and ensuring completion of trial deliverables
• Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trial(s) by working in close collaboration with other functional team members
• Identify challenges to study timelines/deliverables and offer creative action plans to the team/sponsor
• Lead CRAs as they establish relationships with their sites for high quality oversight of monitoring, regulatory, IP, site payment and overall site correspondence activities
• Maintain team focus on study priorities through efficient cross-functional partnerships and effective communication to achieve the highest level of client satisfaction

Clinical Trial Manager – Senior Clinical Trial Manager

• You will be the hub of central intelligence for the studies you will be managing and will lead CRAs and oversee all clinical aspects of your study across multiple countries, ensuring timeline adherence and scope, whilst ensuring quality delivery.
• We encourage high-energy, dedicated professionals who enjoy a challenge, thrive in the details and flourish in dynamic environments to explore this opportunity.
• We are addressing the challenges facing the research and development of novel compounds in Oncology and are dedicated to positively impacting the health and lives of patients around the world.

Clinical Trial Manager – Senior

• Management and operational delivery of the clinical elements within a trial including site selection, start-up, enrolment management, site engagement and support, monitoring planning and execution, data cleaning activities and close-out
• Successful execution of assigned trials and ensuring completion of trial deliverables
• Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trial(s) by working in close collaboration with other functional team members
• Mentoring and training of team members
• Identify challenges to study timelines/deliverables and offer creative action plans to the team/sponsor
• Lead CRAs as they establish relationships with their sites for high quality oversight of monitoring, regulatory, IP, site payment and overall site correspondence activities
• Maintain team focus on study priorities through efficient cross-functional partnerships and effective communication to achieve the highest level of client satisfaction

Payroll

• Co-ordinate and process monthly payroll across multiple European counties.
• Review and verify payroll data, including earnings and deductions.
• Prepare and submit payroll reports to stakeholders.
• Employee support for payroll-related inquiries.
• Conduct system audits and reconciliation for payroll data.

Payroll Specialist

• We have an opportunity for an experienced Clinical Trial Manager to join our growing team. Candidates can work remotely in UK, Hungary, Poland, Romania, Serbia or Slovakia.
• You will be the hub of central intelligence for the studies you will be managing and will lead CRAs and oversee all clinical aspects of your study across multiple countries, ensuring timeline adherence and scope, whilst ensuring quality delivery. We encourage high-energy, dedicated professionals who enjoy a challenge, thrive in the details and flourish in dynamic environments to explore this opportunity.
• We are addressing the challenges facing the research and development of novel compounds in Oncology and are dedicated to positively impacting the health and lives of patients around the world. If you take a consultative approach to trial management, proving to be a valuable partner in the trial operational delivery process, don't miss exploring working with us.

Clinical Trial Manager / Senior Clinical Trial Manager

Clinical Operations

• Serve as primary point-of-contact and primary escalation point to the client
• Coordinate and oversees all functional services including external vendors to the established timeline and budget
• Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate
• Ensure functional areas are fully aware of the study scope and are managing the scope for their functional areas accordingly
• Manage the financial health of assigned studies, including oversight of the project profitability, billable project hours, and compliance with on time, accurate billing and forecasting to support business objectives
• Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and quality
• Ensure Quality management for assigned projects, including eTMF Inspection readiness, implementation of quality notification incident forms and / or corrective and preventative action plans to address any quality findings
• Maintain integrated collaboration with all functional operations in the delivery of the program and review as necessary of other study documentation
• Establish tracking metrics to monitor trial and team progress towards project goals
• Prepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise
• Lead both internal and client meetings and set expectations for the project team
• Communicate effectively with client and Precision management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues
• Ensure study specific training is implemented in collaboration with functional areas and ensure study specific training compliance for the duration of the project
• Support business development and marketing activities as appropriate, including travel to Bid Defence meetings as required
• Perform other duties as assigned by management
• Remain compliant with organisational training, time-reporting and any other administrative duties as required

Senior Scientific Associate – Senior Medical Writer, Promotional Medical Writing

Medical Writer – Promotional Medical Writing

Medical Director – Market Access

Executive Director, Project Management

AI Engineer

Director, Quality Assurance – Systems

Clinical Research Associate I

Clinical Trial Manager – Senior Clinical Trial Manager

Clinical Trial Manager – Senior

Clinical Trial Manager – Senior

Clinical Trial Manager – Senior

Payroll Specialist

Clinical Trial Manager / Senior Clinical Trial Manager

Clinical Trial Manager – Senior Clinical Trial Manager

Clinical Project Manager