Job Overview: Corporate Counsel Client Contracts provides legal support and counseling for Fortrea and their business leaders for matters relating to client agreements and performance thereof. As the Corporate Counsel, you will be responsible for providing advice and counsel on a wide variety of client contracting and relationship issues for our global operations. The role is primarily focused on supporting contracts management, business units and operations, and initiatives within the corporate functions and departments. This role works closely with the Senior Counsel- Client Contracts to provide day-to-day advice and subject matter expertise across the full range of client contracting matters, operational performance and matters impacting the global business. Summary of Responsibilities: Provide advice and support to Company departments on client issues in a commercially reasonable manner that protects the company’s fundamental interests and in a manner consistent with company rules, practices, and policies. Collaborate with other department staff to provide advice and support that accurately reflect the company’s obligations or rights and understandings with clients. Provide advice and support for the drafting, negotiation, and review of company contracts by commercial contracts team and other members of the department’s staff. Participate in negotiations with clients and their counsel as required. Provide advice and counsel to the business and other stakeholders regarding client disputes, performance issues, quality events and other client-related matters that may pose legal risk to the company. Suggest improvements to company contractual templates on an ongoing basis in response to emerging trends, customer preferences, and the company’s risk management posture. Lead or support dispute resolution and claims management Recommend improvements and implement systems to ensure the prompt and effective processing of requests for support. Promote adoption of company-wide risk management initiatives, contracting policies, and other corporate goals as directed. Implement strategies and policies that minimize risk exposure, including (but not limited to): preventive legal training, timely and accurate advice to company operational staff, and careful review of company contracts or other obligations in a manner consistent with guidance provided. Provide legal support for confidentiality disclosures and client disputes Conduct legal review of marketing and communications materials Fulfill other duties as required by the Department and the Company. Qualifications (Minimum Required): Education level: Juris Doctor degree or equivalent Ability to maintain confidentiality of information during interactions with staff at all levels Excellent contract drafting and negotiation skills Experience reviewing commercial contracts and providing practical, business-focused advice Comprehensive knowledge of general corporate business practices and a sound understanding of contracting models and commercial practices is required. Ability to counsel, interact with and present to mid-level and senior executives. Proficient with MS Office products Excellent written and verbal communications skills. Excellent drafting and legal interpretation skills. Sound analytical skills to review matters and identify key legal issues. Effective time management and organizations skills. Must be pro-active, be able to work independently and possess the initiative to drive projects and matters forward to resolution. Dedication to fostering an inclusive culture and value diverse perspectives. Experience (Minimum Required): 8+ years of experience with a reputed law firm or as an in-house lawyer. Industry experience or knowledge of clinical development strongly preferred Preferred Qualifications Include: MS Office, Teams, Workday, Sharepoint Physical Demands / Work Environment: Remote role Learn more about our EEO & Accommodations request here.

Summary of Responsibilities: Facilitate the creation, revision, or inactivation of all project training requirements in the LMS. Provide regular updates to project leaders and project coordinators on the status of all projects related training requirements. Monitoring and tracking compliance of study teams to training requirements leveraging LMS reporting capabilities and excel. Send notifications to team members that are delinquent in completing training requirements. Escalation of repeated delinquent training requirements to project leads. Assign and remove role-based curricula to staff members throughout the life of the study. Ensure accuracy and quality of all assignments and curricula for which they are responsible. Administer updates to assignments and curricula in the LMS. Run ad hoc reports from the LMS as needed. Perform regular reconciliations between LMS generated compliance reports and project team-maintained directories. Extract from the LMS and file training records of all team members in the Trial Master File at study close. Ensure all training requirements are removed and inactivated at study close out. Support Project Training Supervisors with ad hoc requests. Assist the Learning Operations and Solutions Strategy function as required with ad hoc tasks. Perform other administrative duties as assigned by management. And all other duties as needed or assigned. Qualifications (Minimum Required): Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Language Skills: Speaking: English Required. Writing/ Reading: English Required. Experience (Minimum Required): Minimum two (2) years administrative experience or equivalent training/experience 1 year in a Clinical Research or Pharma. LMS (Saba Cloud) experience preferred. Advanced knowledge of Excel and ability to analyze data. Experience with SharePoint. Management of multiple projects. Experience working on teams. Understanding of clinical trials and GCP. Knowledge of LMS a plus Data Entry Skills. Quality and compliance tracking. Preferred Qualifications Include: Bachelor's degree -preferably in life sciences. in lieu of degree – 3-5 years relevant experience. Physical Demands/Work Environment: Standard office environment. Must be able to work at a computer keyboard 6-8 hours per day. Learn more about our EEO & Accommodations request here.

Support to CPDS (Chemical and Pharmaceutical Development & Supply) team (1 FTE): Training management (Curricula maintenance and updating, daily follow-up for trainings, Instructor Lead Course (ILC) creation, new users/existing users training management in Compliance wire (CW), etc. Electronic Lab Notebook (ELN) support activities (spreadsheet validation, periodic review of users, user groups, templates etc. Tru‐ vault Docs handling (controlled prints, uploading & routing of documents for review/approvals, Projects, SOPs, work instructions (WI), forms etc. Activities related to upgradation of existing systems/software (e.g. Windows 10 migration, Project Olympus, RIMS 5 etc.) Responsible for computerized System Validation Scientific support systems like Deskman, FR5, Open lab, Empower as well as compliance and few DI aspects etc. Learn more about our EEO & Accommodations request here.

Job Overview: Lead writer responsible for preparation of clinical study protocols and clinical study reports (CSRs), and other clinical documents as needed. Provides support to more experienced writers with the preparation of complex clinical documents. Interpretation of clinical, pharmacokinetic, pharmacodynamic and statistical results as appropriate. Production of scientific publications and other documents (e.g. abstracts, posters, manuscripts, etc). Oversees and coordinates other writers on CSR appendices compilation and narrative projects. Prepare and review patient safety narratives and CSR appendices. Ensure timely delivery of high-quality documents to internal customers and Sponsors. Works with the management team to provide training to Medical Writers to ensure best working practices are maintained. Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time. Summary of Responsibilities: Prepares protocols and CSRs, including interpretation of clinical data and statistical results as appropriate. Work under guidance from colleagues to assist development of protocols, CSRs and other clinical documents on complex studies and programs. Prepare and review patient safety narratives. Leads project management and coordination of narrative projects. Oversee and coordinate other writers on CSR appendices compilation. Prepare documents in accordance with Fortrea/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines. Participate in review of Statistical Analysis Plan (SAP) and Tables, Figures and Listings (TFLs) to ensure appropriate data presentation for CSR purposes. Provide feedback on SAP and TFLs to project team as needed. Incorporates internal and/or external review comments on clinical documentation. Prioritize and forward plan workload to a high standard; to advise Management of problems promptly. Participate independently in internal and external client meetings. Lead meetings as appropriate. Responsible for project coordination and adherence to project timelines and budget. Identify ways to improve the efficiency and quality of work processes. Mentor Associate Medical Writers and Medical Writer I, as appropriate. Provide peer review and input on deliverables prepared by colleagues, as appropriate based on experience. Provide training to Medical Writers and other staff as appropriate. Represent department in audits and inter-department working groups. Comply with Fortrea internal processes and procedures. Performs other duties as assigned by Management. Qualifications (Minimum Required): Minimum of first degree in life sciences (or equivalent). Advanced degree (e.g., PhD or Masters) preferred. Experience (Minimum Required): Typically, minimum 3 years medical writing experience including 1 year as medical writing project lead. Excellent command of written and spoken English. Good written and verbal communication skills. In-depth knowledge of MS Word. Good organizational and time management ability. Excellent interpersonal skills. Knowledge of ICH guidelines applicable to medical writing. Good understanding of medical/scientific terminology and experience in data analysis and interpretation. Physical Demands/Work Environment: Office environment. Learn more about our EEO & Accommodations request here.

Job Overview It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. The individual will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary Of Responsibilities Take ownership of assigned aspects of quality reviews on projects. Compile metrics and identify quality trends. Assist in addressing periodic client quality reviews and other ad-hoc client quality findings. Prepare initial drafts of Corrective and preventive actions. Perform ongoing review of a sample of various cases or safety reports for global regulatory submissions, labeling / regulatory documents for Fortrea clients e.g., Annual Reports (IND and other), PSURs, PADERs, Clinical Study Reports, Core Data Sheets, USPI, centralized SPC’s, Med Guides etc. Assist with the overall functional quality operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Take ownership of assigned CAPAs with respect to ensuring that the actions are closed and produce documentary evidence to that effect in coordination with the project managers. Contribute to process reviews, own certain aspects of the reviews and use the results to help identify process improvements and develop process standards. Contribute to designing and tracking training schedule and training material for new hires and existing team. Help initiate discussion forums on Quality errors within assigned project and identify process improvements, share best practices across projects. Assist in coordinating respective client or external audits of the assigned projects. Draft sections of the Quality Management Plan for assigned project. Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Lead / Quality Manager. Implement and promote use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures and assume accountability for the deliverables. To respond/review to medical information queries/product quality complaints/general queries that may be received over the telephone call, email, fax etc. Review recorded information that may be received over the telephone call, email, fax etc. Execute drug safety data management processes – a combination of call intake review, call dialogue documentation review and case follow-up. Guide safety associates in managing voice calls (as required). Perform any other support activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources. Perform Analysis of data and if required, suggest strategies for process improvement/excellence. Perform and Review of analysis of data performed and drive strategies for process improvement/excellence. All other duties as needed or assigned. Learn more about our EEO & Accommodations request here. Show more Show less

Summary Of Responsibilities Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to: Hands on experience working on clinical trial cases, spontaneous cases, Post marketing solicitate(PMS) and good to have LAM. Data entry of safety data onto adverse event database(s) and tracking systems. Review of adverse events for completeness, accuracy and appropriateness for expedited reporting. Write patient narratives and code adverse events accurately using MedDRA. Determine listedness against appropriate label (for Marketed products, if applicable). Identifies clinically significant information missing from the reports and ensures its collection and follow-up. Ensure all cases that require expediting reporting to worldwide Regulatory Agencies and other required parties are processed swiftly and appropriately within required timelines. Reporting of endpoints to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required, within study specified timelines. Submission of expedited Serious Adverse Event (SAE) reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required and as agreed with client during study set-up, within study specified timelines. Perform Database reconciliation with Data Management team or sponsor/client as needed. Perform processing and/or review and submission of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs), including but not limited to: Maintenance of adverse event tracking systems. Set-up and maintenance of project files and central files for documentation. Assist with the reporting of ESRs and PSRs to clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel, as required, within study specified timelines. Maintain a strong understanding of Fortrea’s safety database conventions or client specific database conventions, as appropriate. Perform quality review or peer review of processed reports and support the Line Management with trends and actions needed. Begin participating in signal detection and trend and pattern recognition activities, as appropriate. Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs) like Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs) etc. Begin participating in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided. Support/train/mentor less experienced safety staff in all aspects of case-handling, adverse event reporting. Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance. Assist with review and update of Safety Management Plans (SMPs), Reconciliation Plans, and other safety- specific plans ensuring optimal efficiency. Participate in Fortrea project team and client meetings, as appropriate. Prepare and support coordination of safety study files for archiving at completion of projects. Contribute to root cause analysis, including the CAPA plan development and implementation. Support Audits and/or inspections preparation. Assist in review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients, if applicable and coordination of end point committees. All other duties as needed or assigned. Learn more about our EEO & Accommodations request here. Show more Show less

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe. Perform allied activities such as generation of outputs/reports from the databases or safety systems, distribution of data requests, sales data calculations, regulatory website searches, collating report planning materials, etc. Author parts of various safety reports for global regulatory submissions, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports, Development Safety Update Reports, Risk Management Plans, and other documents as assigned. Develop the assigned report parts, examples of which may include sections with majorly pre-populated template text, re-use of content from other documents, or low to medium complexity of safety analyses. Review and annotate line listings, prepare case narratives ordata summaries, and present data per approved strategy. Participate in comment resolutiondiscussions for the assigned sections. Support medical writers in signal detection activities, including data cleaning, review, and annotation of line listings, creating supporting material for signal review meetings, and preparing parts of signal reports. Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com. Fortrea Is Proud To Be An Equal Opportunity Employer As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply. For more information about how we collect and store your personal data, please see our Privacy Statement. If you require a reasonable accommodation to complete your job application, pre-employment testing, job interview or to otherwise participate in the hiring process, please contact: taaccommodationsrequest@fortrea.com. Please note that this e-mail address is only for job seekers requesting an accommodation. Please do not use this e-mail to check the status of your application. Show more Show less

Job Overview Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post marketing period. Summary Of Responsibilities Undertake primary medical review of cases, including medical assessment of the case for seriousness, listedness/labeling, causality, adverse event coding and narrative review. Update and document daily case data, case-feedback in appropriate trackers/tools to facilitate tracking and workflow management. Assume complete responsibility for all assigned deliverables in line with expected quality, compliance, and productivity SLAs and KPIs. Provide training and guidance to the case processing team on medical aspects of case processing, only after a tenure of 1 year. Performs aggregate and signal analysis activities, as required in support of single case processing. Creates, maintains, and assumes accountability for a culture of high customer service. Learn more about our EEO & Accommodations request here. Show more Show less

PDE / OEL calculation and report preparation OTC / Self-care formulas safety assessment Raw material safety assessment Extractable and Leachable safety assessment Impurity qualification INCI-Tox.Profile preparation for OTC / Self-care ingredients Authoring Non-Clinical Overview: Module 2.4 Toxicology literature review and report preparation Learn more about our EEO & Accommodations request here. Show more Show less

Are you ready to lead and shape the future of compliance and data privacy at Fortrea? As the Vice President, Corporate Compliance & Data Privacy, you will play a pivotal role in ensuring our company's adherence to regulatory standards and ethical practices. This position offers a unique opportunity to oversee the development, implementation, and maintenance of our compliance and ethics program, providing strategic guidance to management and operations teams on industry-related issues. You will be responsible for conducting periodic compliance risk assessments, developing corrective action plans, and managing compliance processes that support reporting of compliance issues. Additionally, you will lead our privacy program, ensuring operational processes for privacy compliance are effectively implemented. With a global scope, you will interact with key stakeholders across various regions, including the General Counsel, VP, Deputy General Counsel, and Chief Compliance, Quality and Regulatory Affairs Officer. This role requires a dynamic leader with excellent judgment, interpersonal skills, and a passion for solving complex problems in a creative and pragmatic way. Join us at Fortrea and make a significant impact by driving compliance excellence and fostering a culture of integrity and transparency. Your expertise will be instrumental in shaping our company's future and ensuring we remain at the forefront of the industry. Summary Of Responsibilities Possess knowledge of regulatory, compliance, and other legal topics related to clinical trials research and drug development including fraud and abuse laws, anti-kickback regulations, anti-corruption, trade sanctions, FDA regulations, transparency, and data privacy. Oversee the development, implementation and maintenance of the Company’s compliance and ethics program and privacy program, including all related codes of conduct, policies, processes, and procedures. Provide strategic guidance to management, business and operations teams on compliance- and privacy-related issues affecting the industry. Develop, implement, and deliver communications and training. Maintain and manage compliance processes that support reporting of compliance issues, including a system to track and document all investigations through resolution and an internal compliance audit program. Conduct periodic compliance risk assessments; develop/implement corrective action plans for resolution and mitigation of concerns. Provide leadership for privacy program, including implementing operational processes for privacy compliance. Perform periodic assessments and benchmarks of the programs to ensure effectiveness over time. Manage department staff to ensure the right skills, knowledge and experience is obtained to adequately address the needs of the organization. Provide reports and presentations to the Board of Directors and management team concerning the operation and progress of compliance efforts and the status of investigations. Qualifications (Minimum Required) Juris Doctor from an ABA accredited law school or equivalent Professional degree/designations/certifications/licenses legally required (i.e., RN, MD, VDM etc.). Admission to a U.S. State Bar or EU equivalent Solid working knowledge of other laws, regulations, and industry standards that affect the development and commercialization of pharmaceutical and biotechnology products Experience (Minimum Required) Minimum of 10 years of overall experience (law firm or in-house) Experience in a senior-level compliance leadership role Team player with excellent judgment and interpersonal/communication skills Ability to constructively counsel and influence clients in making the right decisions Experience managing attorneys and commitment to talent development Innovative, forward-thinking, and results-oriented with a passion to solve complex problems in a creative and pragmatic way Capacity to simultaneously handle a variety of complex legal matters with minimal guidance Demonstrable experience taking ownership of issues and providing practical advice Ability to prioritize and undertake mission critical tasks in a fast-paced environment Preferred Qualifications Include Experience in the pharmaceutical, life sciences, biotechnology, medical device, or healthcare industries is strongly preferred Experience with cross-cultural communications a plus Learn more about our EEO & Accommodations request here. Show more Show less

The Costing Manager I is a position that sits within the Costing Department, as part of the Enterprise Client Solutions group. The role is primarily charged to develop proposals and pricing solutions for Biometrics services, working individually and/or with the Costing Directors and will predominantly liaise with the Biometrics Management teams and the Costing Directors on a daily basis. Interactions with other functional roles from Strategy and Planning, Therapeutic Area Business Units, Project Management Centre of Excellence, Client Services, Business Development, Global Clinical Trial Organization (GCTO), Biometrics, Drug Safety and Global Regulatory Services will also be necessary in accomplishing the job. Essential Job Duties Serves as a Costing Manager to support the costing department to ensure clear alignment of project costings to customized delivery strategy by performing but not limited to the following tasks: Review RFP scope and specs and initiate the costing process by initial update of the pricing tool and ensure that this is updated and accurate on an ongoing basis during the cost finalization process Review, update and adjust the initial system generated default budget independently or after feedback and direction from costing director/s and other stakeholders Attend all team meetings during the RFP process like but not limited to- risk assessment for RBM, strategy, pricing specification, pricing delivery or challenge call, senior management call and bid defense preparation Lead and deliver the full proposal, ballpark, abbreviated response, letter and/or re-cost estimates by accomplishing the complete RFP process independently with administrative support from Proposals Associate. Deliver individually or under supervision from the Costing Director and manage all delegated aspects of costing compilations for RFP responses and non-compete awarded projects. Determine appropriate Biometrics scope and deliverables for new RFPs based on available Protocol and/or Synopsis and schedule of events (SoE) Establish and maintain a close relationship with Biometric leadership to ensure new technologies and platforms are accurately reflected in proposal response. Review proposed pass through items and costs for new RFPs and request adjustments if required to ensure accurate pass through costs Review and respond to queries from vendors during RFP phase, review proposed vendor quotes and request adjustments in consultation with costing director/s if required to ensure accurate vendor costs Support writing and review of the assumptions document included in RFP response to ensure accuracy and alignment with the proposed budget Support writing and review of RFI response to ensure questions have been accurately addressed and aligned to current business practices as defined in Standard Operating Procedures Liaise with Biometrics management for project resource assignments and handover requirements during the RFP or on award as necessary. Negotiate for team assignments with relevant experience and availability after review of the proposed CVs. Review and coordinate with pricing to ensure accurate mapping and finalization of client budget grid with Fortrea WBS codes Support and contribute to ongoing updates of Biometrics algorithms by working in close coordination with the costing director/s, Biometrics Management and other relevant stakeholders. Contribute to the costing director team in any strategic process improvement initiatives Perform other duties as assigned by management of the Costing Department Qualifications (Minimum Required) Bachelor's degree or equivalent and relevant formal academic qualification Experience (Minimum Required) A minimum of 6 years of experience in either Data Management or Biostatistics or Statistical programming with a CRO/pharma/other related experience to successfully perform the essential job duties Excellent customer service skills, attention to detail and ability to be persistent while maintaining tact Demonstrated computer skills – requires excellent MS Office experience (specifically Excel, Word, Outlook) Demonstrated text editing and writing skills (based on business unit and/or team expectations) Demonstrated ability to plan, multi-task and prioritize Demonstrated teamwork, communication (written and verbal), and organizational skills Proven ability to work independently Ability to work to deadlines Strong analytical skills Ability to communicate appropriately and effectively with internal stakeholders, clients and Fortrea senior management Positive attitude and sense of urgency Ability to work across Fortrea Business Units Should be comfortable working in the 2nd shift (2 – 11 pm IST) Learn more about our EEO & Accommodations request here. Show more Show less

Job Overview Data Management leadership on studies and take responsibility for the development of the project documentation, system set-up, data entry and data validation procedures and processes assigned to more junior staff. Assume responsibility for all DM activities (from study start-up to database lock) according to client quality expectations, within project timelines and budgets. Work directly with Sponsors to understand their direct requirements and lead implementation of those requirements. Regularly review client specific process to ensure they remain optimal for Sponsor and Fortrea. Summary Of Responsibilities Lead studies including (but not limited to) a combination of healthy volunteer and patient populations, multi-site, client management required or reduced timelines. Ability to organize and effectively prioritize workload and deliverables. Be accountable for all DM deliverables as assigned per the established timeline; providing instruction to their DM study team(s) and review of their study team’s output to ensure the highest quality, while adjusting resource allocations accordingly. Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs. Work with the Project Manager(s) to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team as necessary, including at study initiation meetings. Provide DM project team leadership and accountability; leads data focused internal project team meetings; meets frequently with the study leads of EDC Design, SAS Programming, Statistics, and PK to ensure that all deliverables are planned and coordinated intradepartmental; proactively identifies potential risks/mitigations, effectively communicates data-driven discussions in order to achieve database lock dates; keeps the Project Manager apprised of project progress. Maintain awareness of other Biometrics functional group deliverables to be able to support risk and mitigation strategies, including impact on DM resources or deliverables and consult with Project Manager (or designee) and/or functional group management as necessary. Keep Project Manager (or designee), Biometrics management team and/or sponsor services informed of pertinent project or sponsor related information (i.e., budget status, work scope changes, timeline impacts). Performs other related duties as assigned by Line Management. Develop and maintain client relationships and review client satisfaction surveys. Track scope changes and work with the Project Manager to ensure that Sponsor approval is received, and the scope change processed. Provides leadership, mentorship, and coaching in DM related clinical trial processes to the internal study team. Provide support to DM managers on the performance evaluation of other team members, provide constructive feedback to aid in career development, interpersonal skills and achievement of competency standards. Accountable for learning new DM technologies and applied processes, keeping up to date with industry wide technology and feasibility for process improvement at Fortrea. Maintain accurate records of all work undertaken. Perform reconciliation of the clinical database against safety data, laboratory data or any other third-party data as appropriate. Utilize local laboratory systems and batch data load facilities where appropriate. Represent DM and where necessary overall Biometrics in new business opportunities. Attend and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team. Actively promote Biometrics services to sponsors whenever possible. All other duties as needed or assigned. Learn more about our EEO & Accommodations request here. Show more Show less

Job Overview Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process, which may include safety data collected from clinical trials and/or post marketing settings (i.e., unsolicited reports). Manage and process expeditable adverse events to the required standard and submit them to the client and/or the regulatory agencies (if required) within the agreed/stated timelines. Responsible for providing this service to clients either as a support function to the client project groups or as stand- alone business. Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost effective manner. The role will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary Of Responsibilities Perform case intake and triage of the incoming safety information or reports from various sources either spontaneously or from a clinical trial. Assist with processing of the adverse events, including but not limited to: Data entry of safety data onto adverse event tracking systems. Write patient narratives and code adverse events accurately using MedDRA (for Marketed products, if applicable). Assist in the listedness assessment against appropriate label (for Marketed products, if applicable). Assist in generation of queries and collection of missing or discrepant information in consultation with medical staff, if needed. Submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, as required within the agreed timelines. Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (Clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel etc.), and prioritize the reports for processing and submission within the regulatory and/or study specific applicable timelines. Assist in the reconciliation of databases, as applicable. Work within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs) etc. as appropriate. Assist in the maintenance of supporting files/ documentation regarding adverse event reporting requirements in all countries, if applicable. Support upload/archival of case/study/project documentation, as appropriate. Build and maintain good PSS relationships across functional units. Support compliance of operations with governing regulatory requirements. All other duties as needed or assigned. Qualifications (Minimum Required) Healthcare professionals with 0 to 6 months relevant experience. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. To be used in lieu of experience, Degree required to be in one or more of the following disciplines: Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area *Safety experience includes actual experience of processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions. ** Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, working in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance. Experience (Minimum Required) Attention to detail. Team player. Solid written and verbal communication skills. Accurate math and spelling skills preferably with an aptitude for handling and proof-reading numerical data. Knowledge of MS office Windows applications beneficial. Ability to operate standard office equipment. Physical Demands/Work Environment Office Environment Learn more about our EEO & Accommodations request here. Show more Show less

Job Overview Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process, which may include safety data collected from clinical trials and/or post marketing settings (i.e., unsolicited reports). Manage and process expeditable adverse events to the required standard and submit them to the client and/or the regulatory agencies (if required) within the agreed/stated timelines. Responsible for providing this service to clients either as a support function to the client project groups or as stand- alone business. Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and costeffective manner. The role will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary Of Responsibilities Perform case intake and triage of the incoming safety information or reports from various sources either spontaneously or from a clinical trial. Assist with processing of the adverse events, including but not limited to: Data entry of safety data onto adverse event tracking systems. Write patient narratives and code adverse events accurately using MedDRA (for Marketed products, if applicable). Assist in the listedness assessment against appropriate label (for Marketed products, if applicable). Assist in generation of queries and collection of missing or discrepant information in consultation with medical staff, if needed. Submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, as required within the agreed timelines. Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (Clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel etc.), and prioritize the reports for processing and submission within the regulatory and/or study specific applicable timelines. Assist in the reconciliation of databases, as applicable. Work within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs) etc. as appropriate. Assist in the maintenance of supporting files/ documentation regarding adverse event reporting requirements in all countries, if applicable. Support upload/archival of case/study/project documentation, as appropriate. Build and maintain good PSS relationships across functional units. Support compliance of operations with governing regulatory requirements. All other duties as needed or assigned. Qualifications (Minimum Required) Healthcare professionals with 0 to 6 months relevant experience. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. To be used in lieu of experience, Degree required to be in one or more of the following disciplines: Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area *Safety experience includes actual experience of processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions. ** Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, working in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance. Experience (Minimum Required) Attention to detail. Team player. Solid written and verbal communication skills. Accurate math and spelling skills preferably with an aptitude for handling and proof-reading numerical data. Knowledge of MS office Windows applications beneficial. Ability to operate standard office equipment. Physical Demands/Work Environment Office Environment Learn more about our EEO & Accommodations request here. Show more Show less

Job Overview Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post marketing period. Summary Of Responsibilities Undertake primary medical review of cases, including medical assessment of the case for seriousness, listedness/labeling, causality, adverse event coding and narrative review. Update and document daily case data, case-feedback in appropriate trackers/tools to facilitate tracking and workflow management. Assume complete responsibility for all assigned deliverables in line with expected quality, compliance, and productivity SLAs and KPIs. Provide training and guidance to the case processing team on medical aspects of case processing, only after a tenure of 1 year. Performs aggregate and signal analysis activities, as required in support of single case processing. Creates, maintains, and assumes accountability for a culture of high customer service. Qualifications (Minimum Required) Bachelor’s degree in medical science or MD or DO or equivalent degree. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Language Skills: Speaking: English at ILR level 3+ or higher. Writing / Reading: English at ILR level 4+ or higher. Experience (Minimum Required) Working knowledge of medical sciences, diagnosis and therapeutics including drug treatments and procedures. Knowledge and understanding of regulatory requirements for Clinical Research. Knowledge and understanding of ICH-GCP guidelines. Preferred Qualifications Include 1 to 2 years of Clinical practice experience. Physical Demands/Work Environment Office or home-based environment, as requested by the line manager. Learn more about our EEO & Accommodations request here. Show more Show less

Job Overview Lead writer responsible for preparation of clinical study protocols and clinical study reports (CSRs), and other clinical documents as needed. Provides support to more experienced writers with the preparation of complex clinical documents. Interpretation of clinical, pharmacokinetic, pharmacodynamic and statistical results as appropriate. Production of scientific publications and other documents (e.g. abstracts, posters, manuscripts, etc). Oversees and coordinates other writers on CSR appendices compilation and narrative projects. Prepare and review patient safety narratives and CSR appendices. Ensure timely delivery of high-quality documents to internal customers and Sponsors. Works with the management team to provide training to Medical Writers to ensure best working practices are maintained. Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time. Learn more about our EEO & Accommodations request here. Show more Show less

Summary of Responsibilities: Manage Rewards Vendors and liaise with other external partners. Educates vendors on the minimum requirements for a payment to be made. Chase vendor for invoice or corrections as necessary. Creating, tracking and or extending POs as necessary and getting the required level of approval. Support Benefit Managers in a variety of significant projects. Supports benefits managers in the regions for benefits renewals as required under guidance from respective benefits leaders and external consultants Monitor cost saving activity and report to Benefit Leaders. Act as point of contact for all escalated queries from Global People Services, providing answers or guidance as necessary. Lead and complete benefit surveys as required. Supports the creation and maintenance of benefits process documents. Submits data to provider and payroll in respect of the Benefits, Pension Scheme and Healthcare policies for example, in multiple countries. Qualifications (Minimum Required): Bachelor’s degree required. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required): Minimum 6 years of Benefits management experience. Excellent collaboration, communication, presentation, and interpersonal skills. Expert Excel Proficiency. Project management skills. Learn more about our EEO & Accommodations request here.

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe. Job Overview Lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports. Demonstrate the ability to independently manage the production of safety deliverables, including those involving complex data analyses or important safety issues. Act as a technical lead of the medical writing teams across projects and provide guidance and expertise for developing high-quality scientific content as required for various safety deliverables. Establish good client communication and coordination within writing teams to manage stakeholder expectations and resolve any issues surrounding project/report deliverables. Contribute to scientific publications and represent the company at scientific meetings and conferences. Work with the project management team to implement quality and process improvement initiatives. Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time. Summary Of Responsibilities Write and review various safety reports for global regulatory submissions for clients, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Development Safety Update Report, Clinical Overviews, Medical Device reports, and other documents as assigned. Lead the end-to-end process of report production and ensure the required quality standards and key timelines are met. Provide oversight to co-authors or team of writers as applicable and be accountable for the quality of their work/contributions. Act as the primary point of contact for the client for all report management activities. Engage in client communication to manage stakeholder expectations, present anticipated challenges, propose remediation, and escalate unresolved issues impacting deliverables at an individual report or project level. Author/review RMPs, ad hoc reports, Benefit-Risk Evaluation reports, supporting documents for label updates, reports of effectiveness of risk minimization measures or enhanced pharmacovigilance activities. Lead/participate in various steps of the signal management process. Provide inputs for developing signal strategies and retrieval of data from safety databases, scientific literature, and other sources, as required. Author/review signal evaluation/management reports (ad hoc and periodic) and safety issue analysis reports. Participate in safety/benefit-risk review meetings with clients, discuss results and conclusions from signal/safety analysis, and in collaboration with the safety physician, propose label updates and other risk mitigation measures, as needed. Draft responses (or parts thereof) to health authority questions or feedback and collaborate with cross functional stakeholders in the management and tracking of such feedback. Develop abstracts, posters, manuscripts, and other documents for scientific publication or presentation at conferences or pharmacovigilance forums. Prepare medical information responses for HCPs. Act as a writing coach, provide regular quality feedback, conduct training, and share best practices with associates for promoting the use of clear and concise writing and adherence to style guides, as applicable. Support project management activities such as maintenance of project schedules and tracking of metrics and compliance. Contribute to business development activities, including estimation of resource requirement and responding to RFPs. Create and update labels, e.g. Core Data Sheets, USPI, centralized SPC’s, Med Guides. Conduct literature reviews, formulate and execute search strategies, including those for complex topics or research questions. Implement and promote use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures and assume accountability for the deliverables. Ensure compliance of operations with governing regulatory requirements. Create, maintain, and assume accountability for a culture of high customer service. Perform any additional activities per project requirement or at the manager’s discretion upon completion of relevant training. And all other duties as needed or assigned. Qualifications (Minimum Required) Minimum of first degree in life sciences (or equivalent). Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required) At least 5-7 years of experience in the pharmaceutical industry, with at least 4 years of it in medical writing. Excellent command of written and spoken English. Good written and verbal communication skills. Knowledge of MS Office. Good organizational and time management ability. Excellent interpersonal and leadership skills. Scientific or clinical research or medical writing experience desirable. Good understanding of regulatory requirements, good Pharmacovigilance practices and ICH GCP guidelines. Excellent understanding of pharmaceutical product development cycle. Extensive knowledge of guidelines and regulations pertaining to regulatory submissions for US, EU and emerging markets. Ability to work independently, train and impart knowledge, coach, and mentor team members. Overall understanding of requirements for all types of regulatory documents. Help project managers/deliver managers in managing operations, performance, etc. Preferred Qualifications Include Advanced degree (e.g., PhD or Masters). Experience in drug discovery and pharmacovigilance is desirable. Physical Demands/Work Environment Office environment or remote. Available for travel 15% of the time including overnight stays as necessary consistent with project needs and office location. Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com. Fortrea Is Proud To Be An Equal Opportunity Employer As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply. For more information about how we collect and store your personal data, please see our Privacy Statement. If you require a reasonable accommodation to complete your job application, pre-employment testing, job interview or to otherwise participate in the hiring process, please contact: taaccommodationsrequest@fortrea.com. Please note that this e-mail address is only for job seekers requesting an accommodation. Please do not use this e-mail to check the status of your application. Show more Show less

Summary of Responsibilities: Assists Proposal Managers with all aspects of the appropriate proposal process (text, quote, budget, and/or response to Requests for Information [RFIs]) (i.e., collating data, following up with other departments, meeting minutes, etc.). Responsible for managing opportunities of low complexity, with support. Shadow and/or assist more senior colleagues on opportunities of medium complexity. Review and analyze RFI and/or Request for Proposal (RFP) documents to gain understanding of client requirements and to assist in identifying missing information for budget, proposal and/or RFI response preparation. Collates follow-up questions for additional information as requested. Attend strategic and operational calls related to the opportunity. Works across the organization in matrix environment across multiple time-zones and locations to facilitate the process and complete deliverables. Drafts standard documents in accordance with agreed strategy and Sponsor requirements and expectations under the pressure of changing timelines. Administratively supports facilitating internal and external opportunity management negotiations (i.e., pricing, process, resources, timelines, etc.) as needed. Ensures timely delivery of assigned deliverables. Escalates issues/challenges to Manager for support on resolution. Performs timely and accurate data entry into departmental and/or corporate databases/systems as directed. Seeks appropriate knowledge of the technical and regulatory environments. Contributes to assigned process improvement initiatives and supports implementation. Perform quality control activities per the appropriate process/requirements. Expected to contribute to content library by submitting new content or updates to existing content, using the official content submission process. May be requested to handle the content submission for more senior colleagues. Completes other appropriate duties, as assigned by the manager, which require similar skills in accordance with business needs and common sense. Qualifications (Minimum Required): Bachelor’s degree required in related field or equivalent work experience. Experience (Minimum Required): Minimum 2 years of experience in budget and/or text development, or an equivalent combination of education and CRO/pharma/other related experience to successfully perform the essential job duties. Excellent customer service skills, attention to detail and ability to be persistent while maintaining tact. Demonstrated computer skills – requires excellent MS Office experience (specifically Excel, Word, Outlook). Knowledge of proposal management software applications (e.g., Salesforce.com, Qvidian, Proposal Automation applications) is a plus. Demonstrated text editing and writing skills (based on business unit and/or team expectations). Demonstrated ability to plan, multi-task and prioritize. Demonstrated teamwork, communication (written and verbal), and organizational skills. Proven ability to work independently. Ability to work to deadlines. Strong analytical skills. Ability to communicate appropriately and effectively with internal stakeholders. Positive attitude and sense of urgency. Possesses an ability to work across Fortrea Business Units. Ability to work irregular and/or extended hours as needed to meet the client’s proposal deadline. Learn more about our EEO & Accommodations request here.

Job Overview Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and process expeditable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Responsible for providing this service to clients either as a support function to the client project groups or as stand- alone business. Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. He/she will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary Of Responsibilities Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to: Data entry of safety data onto adverse event database(s) and tracking systems. Review of adverse events for completeness, accuracy and appropriateness for expedited reporting. Write patient narratives and code adverse events accurately using MedDRA. Determine listedness against appropriate label (for Marketed products, if applicable). Identifies clinically significant information missing from the reports and ensures its collection and follow-up. Ensure all cases that require expediting reporting to worldwide Regulatory Agencies and other required parties are processed swiftly and appropriately within required timelines. Reporting of endpoints to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required, within study specified timelines. Submission of expedited Serious Adverse Event (SAE) reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required and as agreed with client during study set-up, within study specified timelines. Perform Database reconciliation with Data Management team or sponsor/client as needed. Perform processing and/or review and submission of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs), including but not limited to: Maintenance of adverse event tracking systems. Set-up and maintenance of project files and central files for documentation. Assist with the reporting of ESRs and PSRs to clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel, as required, within study specified timelines. Maintain a strong understanding of Fortrea’s safety database conventions or client specific database conventions, as appropriate. Perform quality review or peer review of processed reports and support the Line Management with trends and actions needed. Begin participating in signal detection and trend and pattern recognition activities, as appropriate. Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs) like Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs) etc. Begin participating in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided. Support/train/mentor less experienced safety staff in all aspects of case-handling, adverse event reporting. Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance. Assist with review and update of Safety Management Plans (SMPs), Reconciliation Plans, and other safety- specific plans ensuring optimal efficiency. Participate in Fortrea project team and client meetings, as appropriate. Prepare and support coordination of safety study files for archiving at completion of projects. Contribute to root cause analysis, including the CAPA plan development and implementation. Support Audits and/or inspections preparation. Assist in review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients, if applicable and coordination of end point committees. All other duties as needed or assigned. Qualifications (Minimum Required) Non-degree + 2 years of Safety experience * or 4-5 years of relevant experience** Associate degree + 2 years of Safety experience * or 3-4 years of relevant experience** BS/BA + 1-2 years of Safety experience * or 2-3 years of relevant experience** MS/MA + 1-2 years of Safety experience * or 2 years of relevant experience** PharmD + 1-2 years of Safety experience * or 2 years of relevant experience** For PharmD, a one-year residency of fellowship can be considered as relevant experience. Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area. * Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions. ** Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, working in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required) High degree of accuracy with attention to detail. Functions as a team player. Good Communication and presentation skills. Good written and verbal communication skills. Knowledge of medical and drug terminology desirable. Familiarity of Good Clinical Practice (GCP) related to clinical safety documentation. Familiarity with ICH Guidelines. Familiarity of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products. Ability to work independently with minimal supervision. Good keyboard skills, preferably with knowledge of MS office and Windows. * Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions. ** Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, working in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance. Physical Demands/Work Environment Office Environment. Available for travel 5% of the time including overnight stays as necessary consistent with project needs and office location. Learn more about our EEO & Accommodations request here. Show more Show less