• Responsible for the oversight of the following areas: Internal Compliance Team by conducting reviews on various departments within Trillium and Trillium vendors to ensure compliance with laws, rules, regulations and contractual requirements. • Ensure a confidential and effective system for staff to report and/or address concerns regarding perceived compliance violations without fear of retaliation. • Respond to alleged violations of law, rules, regulations or standards of conduct within Trillium by evaluating and/or recommending the initiation of investigative procedures. • Responsible for the oversight of internal compliance which includes but is not limited to internal department reviews, vendor reviews, and issues reported to Service Now ticket system. • Maintain communication with other departments and vendors participating in the reviews.

Job Title: Senior Specialist , Corrective Actions - Global Trade Compliance Job Code: 35832 Job Location: Arlington, VA; Remote; or Melbourne, FL Job Schedule: 9/80: Employees work 9 out of every 14 days – totaling 80 hours worked – and have every other Friday off Job Description: The Senior Specialist, Corrective Actions - Global Trade Compliance, is a full-time position within the Corporate Global Trade function at L3Harris reporting to the Principal, GTC Internal Monitoring. This position will be located in the Arlington, VA office. The Corrective Actions Lead will be responsible for tracking, monitoring, and validating the completion of corrective actions (US and non-US) committed to in voluntary disclosures, notifications to trade regulatory authorities, and reportable compliance incidents (RCIs) that are internally closed out. This role will work closely with Segment Global Trade Compliance Directors, EOs/ECCs, and trade professionals across all regions to ensure timely implementation of corrective actions and compliance with regulatory commitments. The position requires strong project management skills, attention to detail, and the ability to interface with stakeholders at all organizational levels. Essential Functions: - Interface with legal counsel, business segments, and trade professionals to facilitate the Corrective Action Review Board process. - Coordinate and align with business segments on actionable corrective actions, making recommendations on how to address root causes of potential matters. - Develop and maintain a comprehensive tracking system for all corrective actions related to voluntary self-disclosures (VSDs) and RCIs across US and non-US jurisdictions. - Develop and maintain a comprehensive tracking system for recommendations originating from Internal Audit Reviews and Trade Compliance Assessments. - Monitor corrective action completion against committed timelines and escalate delays to appropriate leadership. - Validate corrective actions uploaded by EOs/ECCs into EASE and other systems. - Coordinate with Segment Global Trade Compliance Directors to ensure corrective actions are implemented and lessons learned are shared across segments. - Prepare regular status reports and metrics on corrective action completion rates for senior leadership. - Collaborate with GTC Compliance Investigators to ensure corrective actions address root causes identified during investigations. - Maintain accurate records in accordance with GTC recordkeeping requirements. - Support GTC Investigations and Monitoring in fulfilling Consent Agreement requirements related to corrective action tracking. - Develop and implement process improvements for corrective action management. - Conduct periodic reviews to assess effectiveness of implemented corrective actions. - Assist with data collection in preparation for internal assessments and audits. Qualifications: - Bachelor’s Degree and a minimum of 6 years of prior relevant experience. Graduate Degree and a minimum of 4 years of prior related experience. In lieu of a degree, minimum of 10 years of prior related experience. Preferred Additional Skills: - Working knowledge of IT systems, platforms, and tools a plus. - Proficiency in OCR EASE export administration and licensing software - Experience working under a Consent Agreement - Proficiency in Microsoft Office products (Excel, Word, PowerPoint, Outlook) and SharePoint - Demonstrated consistent application of company and industry business practices and concepts - Specialized knowledge of multiple areas within U.S. Government regulations and business practices - Ability to travel as necessary to support the functions of the job - Experience conducting compliance investigations or audits - Exhibits a high attention to detail, integrity, and discretion - Effective interpersonal and communication skills with the ability to interface with personnel at all levels, both verbally and in writing In compliance with pay transparency requirements, the salary range for this role in California, Massachusetts, New Jersey, Washington, and the Greater D.C, Denver, or NYC areas is $84,000-$156,000. The salary range for this role in Colorado state, Hawaii, Illinois, Maryland, Minnesota, New York state, and Vermont is $73,000-$135,000. This is not a guarantee of compensation or salary, as final offer amount may vary based on factors including but not limited to experience and geographic location. L3Harris also offers a variety of benefits, including health and disability insurance, 401(k) match, flexible spending accounts, EAP, education assistance, parental leave, paid time off, and company-paid holidays. The specific programs and options available to an employee may vary depending on date of hire, schedule type, and the applicability of collective bargaining agreements. #LI-NR1

Senior Regulatory Ops Associate (Publishing)- Canada- Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Senior Regulatory Operations Associate (Publishing) to join our diverse and dynamic team. As a Senior Regulatory Operations Associate at ICON, you will play a pivotal role in managing regulatory documents and processes, contributing to the successful execution of clinical trials and the advancement of innovative treatments and therapies. What you will be doing - Overseeing the preparation, compilation, and submission of regulatory documents for clinical trials. - Managing electronic document management systems (eTMF, eCTD) to ensure compliance and accessibility of regulatory documents. - Providing support and guidance on regulatory operations processes to internal stakeholders. - Collaborating with cross-functional teams to ensure timely completion of regulatory deliverables. - Continuously monitoring and optimizing regulatory operations processes to improve efficiency and compliance. Your profile - Bachelor's degree in a scientific or related field; advanced degree preferred. - Minimum of 3 years of experience in regulatory publishing within the pharmaceutical, biotech or CRO industry. - Proficiency in electronic document management systems (eTMF, eCTD) and regulatory submission software. - Canadian submission background is preferred but not required. - Strong understanding of regulatory requirements and guidelines for clinical trials. - Excellent organizational, communication, and problem-solving skills. Nous sommes actuellement à la recherche d’un(e) Associé(e) principal(e), Opérations réglementaires (publication) pour se joindre à notre équipe diversifiée et dynamique. À titre d’Associé(e) principal(e) des opérations réglementaires chez ICON, vous jouerez un rôle clé dans la gestion des documents et des processus réglementaires, contribuant ainsi à la réalisation réussie des essais cliniques et à l’avancement de traitements et de thérapies innovants. Vos responsabilités - Superviser la préparation, la compilation et la soumission des documents réglementaires pour les essais cliniques. - Gérer les systèmes électroniques de gestion de documents (eTMF, eCTD) afin d’assurer la conformité et l’accessibilité des documents réglementaires. - Fournir du soutien et des conseils aux parties prenantes internes concernant les processus des opérations réglementaires. - Collaborer avec des équipes interfonctionnelles afin d’assurer la réalisation des livrables réglementaires dans les délais. - Surveiller et optimiser en continu les processus des opérations réglementaires afin d’améliorer l’efficacité et la conformité. Votre profil - Baccalauréat dans un domaine scientifique ou connexe; diplôme d’études supérieures préféré. - Minimum de 3 ans d’expérience en publication réglementaire dans l’industrie pharmaceutique, biotechnologique ou au sein d’une organisation de recherche sous contrat (CRO). - Maîtrise des systèmes électroniques de gestion de documents (eTMF, eCTD) et des logiciels de soumission réglementaire. - Une expérience des soumissions réglementaires canadiennes est un atout, mais non obligatoire. - Bonne compréhension des exigences et des lignes directrices réglementaires applicables aux essais cliniques. - Excellentes compétences en organisation, en communication et en résolution de problèmes. #LI-MN1 #LI-Remote What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: - Various annual leave entitlements - A range of health insurance offerings to suit you and your family’s needs. - Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. - Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. - Life assurance - Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. Ideal candidates will have approximately six to eleven months of independent onsite Clinal Research Associate (CRA) experience. Discover Impactful Work Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix. A Day in the Life - Monitors investigator sites with a risk-based monitoring approach: applies root Functions cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable. - Participates in investigator meetings as necessary. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials. - Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. - Provides trial status tracking and progress update reports to the team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System). - Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections. - Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner. - Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Contributes to other project work and initiatives for process improvement, as required. Keys to Success Education and Experience Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered. Valid driver's license where applicable. In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills, Abilities - Basic medical/therapeutic area knowledge and understanding of medical terminology - Ability to attain and maintain a working knowledge of ICH GCPs and applicable regulations and procedural documents - Good oral and written communication skills, with the ability to communicate effectively with medical personnel - Good interpersonal skills Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues - Good organizational and time management skills - Ability to remain flexible and adaptable in a wide range of scenarios - Well-developed critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving - Ability to manage Risk Based Monitoring concepts and processes Ability to work in a team or independently as required - Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software Good English language and grammar skills Work Environment: Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: - Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. - Able to work upright and stationary for typical working hours. - Ability to use and learn standard office equipment and technology with proficiency. - Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.