Summary of Responsibilities: Owns all aspects of the appropriate proposal process (text, quote, budget, and/or response to Requests for Information [RFIs]) for assigned/accountable opportunities (inclusive of managing opportunities autonomously, establishing clear timelines, meeting client requirement, and resolving obstacles with minimal support). Responsible for managing opportunities of medium to high complexity. Shadow and/or assist more senior colleagues on highly strategic opportunities. Responsible for managing deliverables for integrated opportunities (i.e., spanning across multiple Business Units). Assist or be accountable for assigned team workload management. Triage and assign new enquiries as needed. Perform line management of assigned team members under the supervision of a manager or above. Execute supervisory duties for assigned staff including work scheduling, performance evaluation activities, career development and preparation of training plans, where applicable with support of a manager or above. Reviews and analyzes RFI and/or Request for Proposal (RFP) documents to ensure adequate information for budget, proposal and/or response preparation is provided. Follows up with appropriate contact for additional information as required. Identifies and resolves issues around client enquiry requirements and Fortrea capabilities. Organizes and manages strategic and operational calls related to the opportunity. Work across the organization in matrix environment across multiple time-zones and locations to lead the process and complete deliverables. Liaise with third party vendors/vendor managers for provision of quotations where required. Prepares high quality and accurate documents; collaborates with the review team to ensure the responses and strategy meet the Sponsor requirements and expectations under the pressure of changing timelines; proactively works with the review team to craft the appropriate strategy. Is responsible for facilitating internal and external opportunity management negotiations (i.e., pricing, process, resources, timelines, etc.). Is accountable for timely delivery of assigned deliverables. Responsible for resolving issues/challenges and informing Manager. Performs timely and accurate data entry into departmental and/or corporate databases/systems as appropriate. Support client-facing and senior management-facing activities surrounding assigned opportunities as needed, including supporting preparation, attendance, or leading applicable preparation and meetings. Maintains appropriate knowledge of the technical and regulatory environments. Identifies and drives ways to improve the efficiency and quality of processes and the resulting deliverables, influencing key stakeholders as applicable. Contribute to assigned client relationship improvement activities and implementation. Provides training and guidance to new or less experienced staff on all aspects of position requirements, including providing input into training materials. Performs quality control activities per the appropriate process/requirements. Lead sales-focused inbound client visits. Require scientific and/or technical knowledge to support client, lab, and/or operations questions/collaboration. Expected to contribute to content library by submitting new content or updates to existing content, using the official content submission process, and to suggest areas for streamlining/improving content and/or structure. Completes other appropriate duties, as assigned by the manager, which require similar skills in accordance with business needs and common sense. All other duties as needed or assigned. Qualifications (Minimum Required): Bachelor s degree required in related field or equivalent work experience. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required): Minimum 6 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 preferred. 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. Possesses an ability and willingness to work across Business Units. Ability to work irregular and/or extended hours as needed to meet the client s proposal deadline.

Job description : 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 the role of the Lead Statistical Programmer. Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc. Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs. Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated CRFs Reviewers Guides to support SDTMs and ADaMs. Develop specifications for SDTMs and ADaM datasets. Review SAPs and TFL shells from a programming perspective for studies. Mentor less-experienced programmers in the processes around SDTMs, ADaMs and TFLs. Present and share knowledge at department meetings. Respond to QA and client audits, and support qualification audits. Identify processes within programming that will increase productivity, quality, and efficiency. All other duties as needed or assigned

Job description : 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 report

Summary of Responsibilities: Lead the development, management, and execution of category strategies to support Fortrea s strategic imperatives and mission. Partner with leaders across the enterprise to provide efficient and effective category strategies and preferred suppliers. Manage multi-functional stakeholder teams on strategic sourcing initiatives, driving value through supplier relationship management. Conduct regular contract review meetings with suppliers and key stakeholders to ensure performance meets expectations. Cultivate a strong team environment and service culture to deliver timely and quality services. Own and manage the end-to-end Source to Contract process for assigned categories, ensuring compliance and regulatory reporting. Develop, monitor, and analyze procurement metrics and spend analytics to identify opportunities for improvement. Conduct market research and analysis to identify potential suppliers and negotiate favorable terms and pricing. Ensure compliance with company policies, industry regulations, and ethical procurement practices. Deliver savings and value targets across multiple dimensions, including material deflation and cost optimization. Qualifications (Minimum Required): Bachelors degree in Business Administration, Supply Chain Management, or a related field; MBA preferred or a related field. A deep knowledge of sourcing processes, market trends, benchmarks, and best practices across categories under management. In-depth knowledge of category strategy, management and sourcing, methodologies, and best practices. Proven analytical skills and demonstrated ability to solve complex problems to drive value. Deep business and financial acumen and strong strategic and conceptual skills. Demonstrated excellent written and verbal communication skills. Demonstrated organizational, time management, and multi-tasking skills. Working knowledge of data analysis and forecasting tools and ability to develop actionable insights from data. Interpersonal skills and ability to build, develop and maintain trusted relationships both internally and externally. Attention to detail and accuracy in analysis. Ability to make decisions and commit to completion dates. Ability to troubleshoot issues of high complexity. Microsoft Office365 (Word, Excel, PowerPoint, Outlook, Teams, SharePoint) Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required): Bachelors degree in Business Administration, Supply Chain Management; MBA preferred or a related field. 10+ years of experience in procurement or strategic sourcing roles or allied fields Strong negotiation, communication, and project management skills. Ability to work autonomously and operate with significant autonomy Proficiency in procurement software and data analysis tool

Description 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. Own and manage regulatory projects accounts and work towards achieving excellence in service delivery and exceeding Service Level Agreements through team of delivery manager and project managers. Lead the team of cross functional regulatory affairs specialist to support global specification management, raw material qualifications, change control, toxicology, analytical methods and stability reports, packaging material, labelling etc. for global product portfolio including cosmetics/consumers, pharmaceutical, medical devices and biologics. Set up matrix team of regulatory affairs professionals to manage the post approval life cycle maintenance. Lead and manage the regulatory affairs functions; manage delivery of regulatory affairs projects for global customers across all geographies including US, EU, APAC, MENA, LATAM, CIS etc. Participate in and/or lead business development activities e.g., RFI and RFP responses, lead bid defense efforts for potential new regulatory affairs project opportunities. Provide guidance/direction for regulatory affairs staff on development and training needs. Responsible for ensuring that staff are available for projects requiring regulatory submissions services. Responsible for defining RA strategies to meet submission timelines for post approval life cycle maintenance, for implementing these strategies and for the ongoing assessment of the appropriateness for continuing established regulatory strategies and for adjusting the strategies as appropriate. Interface with project management office to generate process productivity metrics and communicate them at appropriate forums. Interface with audit and compliance team to manage QA related issues/escalations within the account Ensure customer satisfaction targets are met and exceeded. Experience (Minimum Required): Minimum of 15 years experience in the pharmaceutical industry in Regulatory Affairs or Regulatory Operations, ideally at least 10 years international regulatory affairs/operations experience in approvals and post approval product life cycle maintenance. Expertise in project governance, escalation, issue resolution and other project management skills Experience of PL management Experience in transition of business processes to an offshore location Experience in budgeting, forecasting and pricing Excellent written and verbal communication and interpersonal skills Ability to manage relationships across diverse set of stakeholders Ability to produce quality materials within tight timeframes Good Negotiation skills Willingness to work in a flexible schedule.

Job description : 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. This role focuses on supporting the development and implementation of the company s compensation policies and programs. Responsibilities include conducting market analyses, performing job evaluations, and participating in salary surveys to ensure competitive and equitable compensation practices. The position involves collaborating with Regional Compensation Manager and providing data-driven insights to support compensation initiatives across the organization. Summary of Responsibilities: Administer and support global compensation programs, including job evaluations, market pricing, and survey submissions. Participate in Year End activities. Perform job description evaluations. Collaborate on the development and maintenance of compensation process documentation and training materials. Administer Fortrea Recognition Program and the tasks in employee HR portal. Conduct research on trends and practices to support business needs and provide actionable insights. Assist with compliance audits and ensure adherence to company policies. Create market analyses for teams and individuals and draw recommendations out of compensation data. Participate in other compensation-related projects and duties as assigned. Qualifications (Minimum Required): Bachelors degree required. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Strong MS Office skills, particularly in Excel and proficient in using other standard office software such as Word, PowerPoint, and Outlook as well as capability in Workday. Experience (Minimum Required): 3-5 years of Compensation Experience Demonstrate proficiency in MS Excel. Flexibility in competently juggling competing priorities. Preferred Qualifications Include: Strong analytical, communication, and problem-solving skills. Knowledge of compensation policies and best practices. Experience in working with EMEA region will be an advantage.

Job description : 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 Duties: Responsible for the supervision of assigned direct reports within department Responsible for Detailed performance review and Management of Direct reports including: Annual Performance Management Development(PMD), Individual Development Plan (IDP), Line of sight goals, Shoves Tugs Responsible for appropriate management of performance issues and its resolutions Addressing employee relations issues and resolving problems Approve actions on human resources matters in conjunction with management Measure performance Indicators for assigned staff Escalate potential Individual training needs and assist in the conduct of training Development efforts6 Conduct, report and follow up on quality related issues for direct reports as required7 Effectively communicate management strategies, policies and procedures in conjunction with leadership teams8 Develop and maintain effective relationship with management team to manage assigned staff in a matrix environment9 Maintaining good working relationship with all the relevant stake holders to ensure opportunity for acquiring additional business Identify Individual training needs and assist in the conduct of training and development efforts globally GCP Quality Oversight:1 Has GCP oversight of direct reports by ensuring GCP training is completed, understood and implemented Identify GCP and quality issues though regular interactions with direct reports Plan and execute required actions to resolve those issues Ensure training compliance with training matrix and records are up to date Provide inputs on relevant SOPs and standard plans/templates for use by Project management and clinical Operations staff Support in the on boarding of new direct reports, this includes conducting and delivering required important job role specific training Ex: GCP, Quality etc Hold direct reports accountable for GCP issue escalations to the management team, the sponsor or QA as applicable7 Hold staff accountable for quality and compliance with client SOP, Covance SOP and deliverable timelines Coach staff on maintaining effective relationship with all the relevant stake holders Represent department in cross functional initiatives as assigned by management and may act on behalf of team when assigned Productivity and Financial Management1 Communicate status of assigned workload for metric reporting2 Perform Weekly review of direct report billable hours and associated utilization per the budget plan (Quarterly annually budget planning) Escalation management about outliers for mitigation Adhere to goals and objectives Engage in resource management activities for direct reports5 Assist with staff recruitment through screening and interviewing6 Financial authority in accordance with current signature approval matrix Accountable for expense management, expense report approval and compliance with travel polity/home based policy of direct report Liaise with all the relevant stake holders in process improvement initiatives including Six Sigma Encourage use of standardized processes and tools in alignment with associated policies to ensure efficiency and productivity Schedule Quality review of reporting line work and ensure costs are in alignment with budget as required

Job description : 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. Key Responsibilities: Uphold the highest standards of ethics and integrity, promoting a culture of ethical behavior and accountability Perform operational, financial, and IT audits to assess internal controls, financial records, operational efficiency, and regulatory compliance. Design and execute audit procedures in alignment with audit objectives and programs, ensuring adherence to auditing standards. Document audit findings and prepare comprehensive audit workpapers within AuditBoard, adhering to established standards. Engage with stakeholders from various regions and cultural backgrounds across the company to understand processes, risks, and controls. Communicate effectively with global teams to ensure alignment on audit objectives and findings, demonstrating cultural awareness and adaptability. Coordinate and manage audit activities across multiple time zones as required by the scope of global audits. Collaborate with teams to document processes, including creating narratives, flowcharts, and walkthroughs, to identify risks and controls. Conduct interviews and walkthroughs with employees and management to gather insights and understand processes. Perform testing of key controls to ensure compliance with SOX requirements. Document audit work related to SOX and operational audits, ensuring accuracy and clarity. Identify control gaps and audit findings, providing constructive recommendations to mitigate risks. Prepare audit reports summarizing strengths, weaknesses, and findings, and monitor managements response and implementation of recommendations. Communicate audit results effectively with stakeholders at various management levels globally. Stay updated on new auditing techniques, regulatory changes, and industry developments. Attend professional development courses and share insights to enhance departmental knowledge and practices. Maintain effective and respectful communication with management and staff during audits. Foster strong working relationships across the organization to facilitate audit objectives. Support ad hoc projects and other duties as assigned by the Internal Audit leadership team. Job Qualifications: The successful candidate will be a dedicated, hard-working and enthusiastic professional, skilled in problem-solving possessing excellent auditing, technical, interpersonal and communication skills, high standards for quality, and the ability to organize, prioritize and manage tasks and work autonomously as needed. Bachelor s degree in Accounting, Finance, or a related field. Professional certifications such as CIA, CPA, or equivalent (preferred but not mandatory). 4 years of audit experience, ideally from a Big 4 public accounting firm or in an internal audit role within a corporate environment. Exposure to risk assessment, internal controls, and audit methodologies. Experience with SOX compliance and operational audits is highly desirable. Strong analytical skills with attention to detail. Proficiency in using audit software (e.g., AuditBoard) and Microsoft Office tools (Excel, Word, PowerPoint). Excellent written and verbal communication skills. Ability to work independently and collaboratively in a team environment. Strong organizational skills to manage multiple priorities effectively. Cultural awareness and ability to work effectively in a global, multicultural environment. Flexibility to collaborate with global teams across various time zones. Willingness to travel occasionally, as required by audit assignments. Commitment to maintaining the highest ethical standards and confidentiality

Job Overview: Serve as a member of the project team with primary responsibility for conducting the clinical data review, query generation / resolution and reconciliation activities to support the Data Management lead with the delivery of clinical data according to client quality and integrity specifications, project timelines and productivity targets. Assist in the development of the project Data Management Plan, including data review guidelines /edit check and eCRF specification. May contribute to setup of the data management systems according to project requirements. Summary of Responsibilities: Ensures that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs. Demonstrates capability to read and follow study timelines for on-time deliverables. Potential to assist with inputs on study design or capable to make suggestions to study timelines when warranted. Assist with review of clinical trial data in accordance with Data Management Plans and/or Data Review Guidelines and raise queries to resolve erroneous, missing, incomplete data. Run and execute additional programs (special listings, reconciliation discrepancy listings, etc.) used to support the review of clinical trial data. Generate, resolve and track queries to address problematic data identified during aggregate data review activities. Interacts with other project team members to support the set-up, maintenance, and closure of the Data Management aspects of the project and attend meetings as required. Generate and QCs data listings for internal data review. May assist or create dummy data to test edit checks and to test database screen design and functionality. Assist or create dummy data to test SAS reports and data listing. Demonstrates the ability to review Edit Check Specifications and Database specifications. Post Data Management documentation and data management related administrative tasks as requested, including maintenance of eTMF as required. Runs study status reports in preparation for Sponsor meetings and to deliver on specific Sponsor request. Assist with the completion of Database Lock and Unlock activities. Supports the training of new staff on project specific Data Management processes. Performs any other duties as assigned. Qualifications (Minimum Required): University / college degree (life sciences, health sciences, information technology or related subjects) or a certification in allied health professions from an appropriate accredited institution. Fluent in English, both written and verbal. Experience (Minimum Required): 3 to 5 years of relevant work experience with increasing responsibility in data management with knowledge of one (1) or more therapeutic areas. Demonstrated time management skill and ability to adhere to project productivity metrics and timelines. Knowledge of medical terminology is preferred. Knowledge of effective clinical data management practices. Knowledge of science or a scientific background is preferred. Good oral and written communication skills. Demonstrate time management skill and ability to adhere to project productivity metrics and timelines. Demonstrate ability to work in a team environment and collaborate with peers. Demonstrate good organizational ability, communication, and interpersonal skills. Demonstrate team working skills and good collaborator skills. Demonstrate a constructive problem-solving attitude while deadline focused with time demands, incomplete information or unexpected events.

Job description : 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 the role of the Lead Statistical Programmer. Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc. Develop and maintain SAS programs to create complete SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs. Produce Define XML/PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs. Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets and contribute to the development of Fortrea and Client standards. Review SAPs and TFL shells from a programming perspective for studies and advise on the development of complex TFL shells from a programming perspective. Mentor less-experience programmers in the processes around SDTMs, ADaMs and TFLs ensuring adherence to department practices and processes. Present and share knowledge at department meetings. Respond to QA and client audits and support qualification audits. Contribute to proposal activities and participate in bid defenses meetings in order to win new business. Continually identify and suggest ways to improve the efficiency, quality and productivity of statistical programming. And all other duties as needed or assigned.

Job description : 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. These are the specific areas of accountability requiring decisions or delivery of results Owns all aspects of the appropriate proposal process (text, quote, budget, and/or response to Requests for Information [RFIs]) for assigned opportunities (inclusive of managing opportunities under general supervision, establishing clear timelines, meeting client requirement, and suggesting solutions for obstacles) May (based on business unit and/or team expectation) be responsible for managing opportunities of low to medium complexity May (based on business unit and/or team expectation) support integrated opportunities (ie, spanning across multiple Business Units)Reviews and analyzes RFI and/or Request for Proposal (RFP) documents to ensure adequate information for budget, proposal and/or response preparation is provided Follows up with appropriate contact for additional information as required Identifies and resolves issues around client enquiry requirements and Covance capabilities with support Organizes and facilitates of strategic and operational calls related to the opportunity May work across the organization in matrix environment across multiple time-zones and locations to lead the process and complete deliverables May liaise with third party vendors/vendor managers for provision of quotations and/or information where required Prepares high quality and accurate documents in accordance with agreed strategy and Sponsor requirements and expectations under the pressure of changing timelines Supports facilitating internal and external opportunity management negotiations (iepricing, process, resources, timelines, etc) as needed Ensures timely delivery of assigned deliverablesIs responsible for resolving of issues/challenges and informing Manager; may seek Manager s advice for complex issues/challengesPerforms timely and accurate data entry into departmental and/or corporate databases/systems as appropriate May (based on business unit and/or team expectation) support client-facing and senior management-facing activities surrounding assigned opportunities as needed, including supporting preparation, attendance, or leading applicable preparation and meetings Maintains appropriate knowledge of the technical and regulatory environmentsIdentifies and participates in ways to improve the efficiency and quality of processes and the resulting deliverablesMay (based on business unit and/or team expectation) contribute to assigned client relationship improvement activities and implementation Performs quality control activities per the appropriate process/requirements May (based on business unit and/or team expectation) support hosting sales-focused inbound client visits May (based on business unit and/or team expectation) be responsible for coordinating on-boarding activities for new starters, including working directly with the management staff to ensure proper on-boarding May (based on business unit and/or team expectation) be expected to contribute to content library by submitting new content or updates to existing content, using the official content submission process Completes other appropriate duties, as assigned by the manager, which require similar skills in accordance with business needs and common sense Experience :Minimum 2 - 4 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 (eg, Salesforcecom, Qvidian, Proposal Automation applications) is preferred 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

Duties: Lead and manage multiple agile product development teams (developers, technical leads, QA professionals, and product managers). Oversee efficient execution of product development initiatives, ensuring quality, security, and resilience. Lead platform upgrades, migration, and modernization efforts following industry best practices. Collaborate seamlessly with Tier 3/4 support teams, assisting with inquiries and cross-departmental communication. Provide personnel leadership, fostering team engagement and conducting year-end performance reviews. Identify and mitigate risks in product development and support functions through proactive measures. Cultivate a culture of continuous improvement, innovation, and experimentation within teams. Qualifications (Minimum Required): Bachelor's degree in Computer Science, Engineering, or a related field. Equivalent relevant experience may be considered in place of educational requirements. Experience (Minimum Required): 10+ years of experience in Software Engineering or a related field. 3+ years in a leadership role managing Software Engineering teams. Strong experience with MACH (Microservices, API-first, Cloud-native, Headless) architecture. Proven expertise in managing scrum teams and overseeing product development. Strong track record of leading products from conception to delivery. Excellent leadership, team management, and interpersonal skills. Strong analytical and problem-solving abilities. Preferred Qualifications: Advanced certifications in project management, cloud technologies, or related fields. Experience leading diverse, cross-functional teams in a global setting. Background in the CRO (Contract Research Organization) or healthcare-related industry. Strong communication skills for stakeholder engagement and goal alignment.

Job description : 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: Serve as a member of the project team with primary responsibility for all documentation requirements in support of Global EDC Solutions tasks to include receiving and logging-in and scanning contractual and validation documentation. Assist project teams with validation tasks as requested, i.e., with the creation, production, printing and tracking of study documentation and controlled documents. Summary of Responsibilities: Serves as a member of the project team with primary responsibilities for all documentation, requirements to support global EDC solutions tasks. Assist project teams with validation tasks as requested. Assist with creation, production, printing and tracking of study documents and other controlled documents as needed. Create and Execute validation test scripts as requested and document the test results. Ensure quality of work. Prioritize workload to meet specified completion dates. Assist with the maintenance of validation metrics. Carry out all activities according to Fortrea Standard Operation Procedures (SOPs) and project specific conventions within the framework of Quality Management and Good Clinical Practice (GCP)/ICH guidelines. Maintain accurate records of all work performed. Perform other duties as assigned by management. Assist with special projects as designated. And all other duties as needed or assigned.

Job description : 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 and technology solutions across more than 20 therapeutic areas. With over 18,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe. Develop, in conjunction with the Global Feasibility Lead, the initial site list for feasibility and site identificationFull oversight of the Feasibility/Site identification process: survey development and programming, local resource training and oversight, oversight of site outreach process, creation of progress reports, site selection tool and decision making, customer interactionCollaborate with Global Feasibility Leads to support collection of country and investigator feedback in the pre-award space; provide summary and analysis of results Responsible for setup and conduct for feasibility/site identification studies according to timeline and quality standards and client expectations Develop site lists according to the program or protocol:Work closely with Global Feasibility Lead, strategy, and start up teams to understand optimal site profileEvaluate the available sources of potential site information, and the pros and cons of each Manage timelines and any changes to the target site list requirements up until the site is fully identified and the target number of potential sites in each defined region and country is achieved Helping to facilitate identity matching by coordinating the triggers for master data managementPerform literature and internet searches as required Learn and utilize the data sources available for site performance data Create electronic surveys using company software and produce any required standalone or topline surveysParticipate in internal planning meetings and contributes during client interactions and interim teleconferences Ensure accuracy and quality of survey driven dataWork with team and other Senior staff to identify potential risks and out of scope activity; discusses contingency plans with stakeholders as appropriate Ensure site identification team in each country is entering and updating internal tracking tools Develop and deliver training of feasibility and site identification requirements/processesLiaise with the global, cross-functional teams, inclusive of legal, start-up, clinical, country teams, and project management Participates in the development, implementation, and maintenance of systems Contribute to audit presentations/documentation based on site ID oversightPerforms any other duties as assigned

Job description 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. Development and implementation of solutions to global technical service issues and concerns regarding EDC tools like Medidata RAVE, Oracle InForm and SAS programming Read, understand and program EDC objects/SAS programming as per the specification documents which meets client requirements and projects Perform any post production changes to the EDC data base or enhancements to the SAS programs like SAS edit checks, listings, Reconciliation listings, Protocol Deviations, ACDR listings etc Perform publish checks, complex structure dynamics, RSG, Balance mapping settings Complete assigned work utilizing Medidata RAVE or Oracle InForm or SAS or other proprietary software according to Labcorp SOPs, Work Instructions ,and project specific guidelines in accordance with Good Clinical Practices Provide suggestions and solutions to the operational issues Train the team on Rave or SAS as required and have them ready to perform the regular day to day activities Mentor the team to make them independent enough to perform day to day activities Perform quality check and ensure the work is delivered with 100% quality Prioritize personal workload to meet specified completion dates and perform work with supervision and direction from managers Maintain study databases for assigned projects and SAS programming as assigned by managers Perform all work with knowledge of regulations pertaining to computerized systems to projects to ensure compliance Ensure quality of personal work Interact with project team members in related discipline eg Clinical Data Management, Clinical Operations and Data Management Display a positive attitude at all times, promoting and contributing to good team spirit in a professional environment Continuously learn and improve communication and technical skills Attention to detail is essential and all tasks must be carried out to the highest standard Develop good problem solving skills and a willingness to learn and seek advice from senior Programming staff Acquire knowledge of other aspects of the work of Programmer/Analyst under the supervision of the senior Programming staff Carry out all activities according to Labcorp SOPs working within the framework of the Quality Management System and to Good Clinical Practice (GCP) Perform other duties as assigned by Manager

Job description : 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.

Job description : 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. With sufficient experience assume the role of a Lead Statistical Programmer for CP studies only with support from senior programming staff. Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc. Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs. Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated eCRFs and Reviewers Guides to support SDTMs and ADaMs. With support from senior programming staff, develop specifications for SDTMs and ADaM datasets. Review SAPs and TFL shells from a programming perspective for studies with support from senior programming staff. Respond to QA and client audits with support from senior programming staff. And all other duties as needed or assigned