• Manage and facilitate anonymization of datasets and documents against planned timelines, in accordance with Incyte SOPs and regulatory requirements. • Assess documents in-scope for public disclosure according to EMA Policy 0070 and Health Canada PRCI. • Work closely with Biostatistics and Programing groups and Medical Writing teams to identify and assimilate the required documents and datasets. • Develop anonymization plans based on direct and indirect identifiers by measuring and mitigating re-identification risk according to GDPR guidance. • Process datasets and documents and apply required transformations. • Contribute to Anonymization Reports to support anonymization packages for policies of Health Canada and EMA. • Ensure accurate and consistent redaction of clinical trial documents to support EU CTR, ClinicalTrials.gov, and Publications. • Quality check of documents redacted/anonymized by other team members. • Collaborate with Regulatory Operations to ensure the publishing of redacted documents in the Regulatory Document Management System. • Experience with the use of Technology Tools for delivery of Anonymized Clinical Documents. • Assist in the development of internal work instructions, training materials, and procedures as needed to comply with global requirements and Incyte policies. • Ability to work with minimum supervision and resolve issues. • Develop and maintain collaborative relationships internally to ensure effective and efficient working relationships and the delivery of high quality deliverables. • Stay informed of new clinical trial disclosure and transparency requirements globally, including but not limited to clinical trial registration and posting of results.

Role Description The Medical Writer will leverage scientific/clinical expertise and exceptional medical writing skills to support development of Medscape Medical Affairs programs delivered at the highest standards. Key Responsibilities - Create high-quality scientific, medical, and/or clinical content for physicians, nurses, pharmacists, and other healthcare providers. - Develop PowerPoint presentations, text-based copy, and other project-related deliverables for multimedia programs across digital, live virtual, and/or in-person formats. - Ensure content alignment with program goals and client expectations. - Engage with thought leaders and medical experts in the specified therapeutic area to support content development. - Maintain up-to-date knowledge of key clinical issues within the therapeutic areas of interest; remain current with relevant literature; clinical practice guidelines; approved therapeutic drugs, regimens, and devices; and therapeutic pipelines. - Create medical education content that is clinically appropriate, instructionally-sound, and adherent to industry regulations. - Support application of adult learning theory, instructional design principles, and best practices for health care provider education for specified projects. - Meet regularly with team members to review work quality, client satisfaction, productivity metrics, and progress toward project-related objectives. - Demonstrate accountability against defined performance standards for working with internal teams and clients. - Complete projects within established timelines and to specifications. Qualifications - Minimum 3 to 5 years’ experience in developing digital, live virtual, in-person, and hybrid medical education programs for healthcare providers. - At least 3 to 5 years’ experience as a medical writer/content developer at a medical education/communications AGENCY. - Preference given to individuals with prior Medical Affairs experience. - Preference given to individuals with established expertise in hematology/oncology, neurology, or immunology. - Highly proficient in written English and verbal communication skills; additional languages a plus. - Highly proficient with Microsoft Office suite - particularly PowerPoint - with excellent editorial skills (writing and editing). - An advanced degree in a medical or science-related specialty (MD, PharmD, RN, NP, PA, PhD) is preferred; minimum of a Bachelor of Science degree (life sciences, public health, or clinical sciences) or similar with several years’ relevant work experience required. Requirements - Excellent computer skills that include working remotely on shared networks and cloud-based systems (e.g., SharePoint, Google Drive, Workfront, and others). - Proficiency with web-based data and document sharing sites and authoring tools (Box, Read Cube, EndNote, Tableau) a plus. - Comfortable in a highly deadline-driven environment; able to pivot quickly between tasks and adapt to rapidly shifting priorities. - Self-motivated and capable of working independently. - Possessing strong problem-solving and time-management skills; capable of addressing unforeseen issues to ensure that project goals and timelines are consistently met. - High degree of professionalism and comfortable building collaborative work relationships with both internal and external stakeholders. - Excellent organizational skills, with a track record of meeting deadlines. - Willingness to travel; estimated up to 15% (during peak times) for program delivery and training opportunities. Benefits - Health Insurance (medical, dental, and vision coverage). - Paid Time Off (including vacation, sick leave, and flexible holiday days). - 401(k) Retirement Plan with employer matching. - Life and Disability Insurance. - Employee Assistance Program (EAP). - Commuter and/or Transit Benefits (if applicable). - Eligibility for specific benefits may vary based on job classification, schedule (e.g., full-time vs. part-time), work location and length of employment. Salary Range $82,500 - $90,000 Depending on Experience.

Role Description - Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records. - Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits. - Prepares and implements project plans related to Clinical Monitoring responsibilities. - Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements. - Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems. - Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial. - Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements. - Ensures adherence to global quality control and CRA performance metrics. - Ensures audit readiness at site level. - Acts in the project role of a Lead CRA as assigned. Qualifications - University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate. - Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements. - Thorough knowledge of monitoring procedures. - Basic understanding of the clinical trial process. - Fluent in local office language and in English, both written and verbal. - Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Requirements - External Candidates: University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). AND a minimum of 2 years of Clinical Monitoring experience. - Internal Candidates: Internal candidates with a minimum of 2 years of Clinical Monitoring experience. - Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines. - Ability to work with minimal supervision. - Have an understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs. - Good planning, organization, and problem-solving abilities. - Works efficiently and effectively in a matrix environment. Preferred Qualifications Include - Thorough working knowledge of Fortrea SOPs for site monitoring. - One (1) or more additional years of experience in a related field (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred. - Phase I monitoring experience. - Life Science or Nursing qualification. - Specific skills, systems, certifications, and/or licenses preferred. - Personal characteristics (leadership, problem solving, interpersonal skills). - Good attention to detail. - Methodical approach to work. - Good understanding of medical and clinical research terminology and clinical research processes. - An understanding of the basics of physiology, pharmacology, and medical devices (when applicable). - Good understanding of the principles of ICH GCP, ISO 14155 (if applicable) and local regulatory requirements. - Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications. - Good oral and written internal and external communication. Strong interpersonal team and organizational skills, personal presentation. The ability to communicate effectively in English. - Focus on Customer. - Innovate and Change. - Pursue Scientific and Process Excellence. - Work with Others. - Achieve Results. - Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors. - Demonstrated ability to conduct clinical operations activities most effectively and efficiently. - Good analytical and negotiation skills. - Experience using e-clinical systems [e.g., clinical trial management system (CTMS)]. - For medical device positions, experience in providing customer service to device end users. Physical Demands/Work Environment - Must be able to sit at a computer for long periods of time. - Must be able to use hands to finger, handle or touch objects, tools or controls, including a computer keyboard, for up to 8 hours per day. - Standard office and/or home working environment. - Clinical Research Unit and hospital environment (administrative only). - Risk of eye strain. - Will involve outside of normal office hours as required by the role. - Travel Requirement is 60% of the time (traveling to study sites).

Title: Document Review Specialist - Bilingual French Location: US Workplace: Non-Exempt - Non-Sales Department: Remote Job Description: Requisition #: 20759 Functional Area: Audit/Risk/Compliance; Office/Clerical Employment Type: Full-Time Work Hours: Monday - Friday 8am - 430pm CST Position Summary J. J. Keller has a REMOTE - Document Review Specialist opening in one of our fastest growing departments called Managed Services. This department is comprised of fleet and regulatory compliance experts who clients rely on to off-load the time consuming / complex tasks of managing driver safety and vehicle compliance. As a Document Review Specialist you will be responsible for auditing various documents on behalf of our clients in a metric driven environment. This position will also be responsible for translating documents from Canadian French to English. Job Responsibilities - Audits driver qualification documents and drug & alcohol information for clients. - Identifies discrepancies, checks systems for pertinent information, and enters information into applicable systems. - Works with Client Service Specialists to obtain and/or validate client information. Updates information in all applicable systems. - Maintains knowledge of the applicable local, state, and federal regulations that pertain to our service offerings. - Maintains confidentiality of client information under the FCRA, HIPAA, and other regulatory entities. Adheres to the department's data security policies pertaining to Personal Identification Information. Benefits and Perks - $20 - $22/hr. - 17 days of PTO + 8 Paid Company Holidays + 1 Paid Floating Holiday - Annual Reviews + Merit Increases + Quarterly Bonus Program - New Hire On-the-Job Training - Medical + Dental + Vision Insurance - 401(k) with Employer Match + Company-funded Profit Sharing Qualifications Experience/Education: - Fluency in speaking, writing and reading French, Canadian French a plus. - High School Graduate or General Education Degree (GED). - 1+ years of experience in a general office setting. - In lieu, will consider a combination of experience and post-secondary education. - Experience in highly regulated industry a plus or ability to learn complex regulatory standards. Other Skills/Qualifications: - Must be proficient in the use of a PC and have the ability to navigate between multiple screens and computer programs. - Strong organizational skills and attention to detail. J. J. Keller provides a competitive benefit package which includes the following (eligibility requirements apply): Medical, Dental, and Vision Insurance, 401(k) and Profit Sharing Plan, etc. The compensation range for this role is $20.00 to $22.00 which varies depending on factors including, but not limited to, a candidate’s overall experience and geographic location. Note that J. J. Keller is not currently recruiting employees to work in California.