• This position reports to Manger/Sr. Manager, Medical Sciences and requires a strong candidate with expertise in the analysis of medical literature, data from clinical trials and pre-clinical studies, and sound knowledge of applicable regulations and standards. • The position will mainly focus on the development of Clinical Evaluation Plans (CEPs) & Clinical Evaluation Reports (CERs), with a potential for future additional responsibility in the development of other clinical evidence documents. • The purpose of this job is to work collaboratively to develop strategies for the creation of CEPs followed by the development of clinical evaluation reports (CERs) per EU MDR, to meet essential requirements in support of submission for CE Mark application to obtain Declaration of Conformity and EU market clearance, re-certification and proposed indication/labeling changes. • Further, the responsibility includes the development of regular CEP and CER updates to maintain EU product conformance. • Interact with internal cross-functional teams (engineering, product development, regulatory, post-market surveillance) to define and plan the strategy for the development of CEPs and CERs for new products requiring CE Mark. • Develop and author clinical documentation for regulatory submissions, mainly key sections of the CEP, and the entire CER document. • Develop and author responses to the requests and questions on the clinical documentation from the regulatory authority. • Possess or acquire in-depth knowledge of therapeutic areas, competitor devices, current clinical/market developments, literature review processes and the ability to keep abreast of current literature. • Participate in and/or perform comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies; stay informed about applicable clinical landscapes and trends. • Provide product guidance and expertise to the clinical librarian to facilitate conducting literature searches on products/product families. • Review scientific literature and interpret and summarize published data on risks, alternate therapies and device-specific benefits; collect and summarize primary data to support risk assessment. • Critically appraise scientific literature and write clinical summaries for products and surgical procedures. • Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities. • Manage CEP/CER timelines required by product development teams and global Regulatory Bodies by utilizing appropriate project management tools. • Serve as the SME and/or functional representative for R&D development activities (e.g., Product or Technology Development Process teams) and support broader Clinical/Medical Affairs activities such as Regulatory submissions/responses. • Perform periodic reviews of risk documentation and product labeling; ensure appropriate updates are implemented. • Provide clinical perspective and support and guide new product development for CE Mark purposes. • May require participation in ongoing core team activities (e.g., weekly meetings) or provide periodic participation and input as needed. • Support the clinical affairs (CA) team with the creation of clinical content for other documents including Investigator brochures, manuscripts, scientific abstracts, conference presentations, and posters based on Intuitive clinical trials. • Support the CA team with the development and writing of clinical study protocols and Clinical Study Reports (CSRs). • Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US and OUS guidelines)

Role Description PAX Health is seeking a New York Licensed Psychologist with experience providing psychological services to individuals with a range of mental health, cognitive, or emotional challenges, including, but not limited to, those involved in workers’ compensation or no-fault cases. - Conduct comprehensive psychological evaluations to assess mental health, cognitive functioning, and overall well-being. - Develop and implement individualized treatment plans to address psychological concerns, support recovery, and promote rehabilitation. - Provide evidence-based psychotherapy interventions, including cognitive-behavioral therapy (CBT), mindfulness-based strategies, and trauma-focused approaches, to manage symptoms of anxiety, depression, PTSD, and related conditions. - Collaborate with interdisciplinary teams, including physicians, case managers, and vocational counselors, to coordinate care and support return-to-function or return-to-work processes. - Advocate for clients to ensure access to appropriate mental health and rehabilitative services, including WC or no-fault cases when applicable. - Maintain accurate and timely clinical documentation, including progress notes, treatment plans, and assessment reports, in accordance with professional and regulatory standards. Qualifications - Doctorate (Ph.D. or Psy.D. in psychology) - Valid New York State licensure - New York State Workers' Compensation Board authorization number upon acceptance of an offer, which is a prerequisite before commencing work. - Ability to work as part of a comprehensive community mental health team and to represent the agency in the community. - Familiarity with community support systems, health care and human service resources, court and police activities, etc. - Good organizational skills and administrative abilities. - Flexibility in days and hours available for scheduled work including weekends. - Knowledge of and the ability to adhere to a professional code of ethics. - Knowledge of and the ability to comply with the state's mental health code. - Appropriate professional registration/certification by state/national authority required. Benefits - PAX Health is an equal opportunity employer and prohibits discrimination and harassment of any kind. - We are committed to providing a diverse and inclusive work environment where all employees are valued, respected, and treated fairly. - Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. - We comply with all applicable federal, state, and local laws governing nondiscrimination in employment. Physical Demands The physical demands described are representative of those that must be met by an employee to successfully perform the essential duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties and responsibilities. In the course of performing this job, one typically spends time sitting, walking, standing, driving, listening, speaking, typing, reading, and writing. In addition, an employee may be asked to carry or lift up to 20 lbs.

Role Description The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA-Manager, the person ensures compliance of study conduct with ICH/GCP and country regulations, our Company's policies and procedures, quality standards, and adverse event reporting requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and Systems. - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. - Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. - Gains an in-depth understanding of the study protocol and related procedures. - Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready. - Participates & provides inputs on site selection and validation activities. - Performs remote and on-site monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased and subjects’ right, safety and well-being are protected. - Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. - Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out. - Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. - Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA-Manager, CRM, TA Head and CRD as needed. - Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites. - Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. - Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required. - Supports and/or leads audit/inspection activities as needed. - Performs co-monitoring visits where appropriate. - Following the country strategy defined by CRD and/or CRA-Manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities. Qualifications - Associate's degree, certificate or equivalent in a scientific / healthcare discipline together with at least 5 years of relevant experience in the healthcare field, including at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO. - Or Bachelor’s degree (or above) together with at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO. Requirements - Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively. - Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines. - Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. - Hands on knowledge of Good Documentation Practices. - Proven Skills in Site Management including management of site performance and patient recruitment. - Demonstrated high level of monitoring skill with independent professional judgment. - Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices. - Ability to understand and analyze data/metrics and act appropriately. - Capable of managing complex issues, works in a solution-oriented manner. - Performs root cause analysis and implements preventative and corrective action. Benefits - Comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits (for employee and family). - Retirement benefits, including 401(k). - Paid holidays, vacation, and compassionate and sick days. - Annual bonus and long-term incentive eligibility, if applicable.

Role Description Cayenta, a division of Harris, is seeking a Vice President of Research & Development who is a business-focused technology leader. This is a pivotal leadership position responsible for driving the AI-centric transformation of our core product suite and the evolution of a large, tenured engineering organization. - Master the balance between executing the strategic, multi-year roadmap for our next-generation CayentaOne platform and supporting the operational realities of a large, profitable install base. - Embed practical AI at every level of the R&D organization, from accelerating our own development lifecycle to delivering intelligent, high-value features for our customers. - Act as a strategic business partner for the EVP, translating technology initiatives into P&L impact. - Lead a complex cultural change and instill a culture of pragmatic, AI-driven innovation. This remote role welcomes candidates anywhere in Canada and the US. Travel is required as needed, approximately 50%. Candidates must hold a current, valid passport and be legally eligible to travel internationally. Salary: 130K - 200K CAD / 91K - 141K USD Qualifications - A proven track record as a trusted technology partner. - Demonstrated experience moving AI initiatives from ideation to live production with measurable P&L impact. - Deep, hands-on experience leading the multi-year modernization of a mature, revenue-generating enterprise software product. - High emotional intelligence (EQ) with demonstrated success turning around or re-energizing a change-resistant engineering culture. - Financial acumen and an understanding of how to run R&D with P&L discipline. Requirements - Drive the AI-Powered Transformation. - Own the execution of the corporate AI mandate within Cayenta. - Translate AI capabilities into revenue-generating or cost-saving initiatives. - Accelerate the CayentaOne roadmap by championing and implementing AI-assisted development practices. - Oversee the product strategy for Cayla, evolving it into a core, agentic AI platform. - Act as the key technical advisor to the EVP and GM. - Manage the entire R&D P&L, balancing the budget between market-driven features and strategic investments. - Lead, mentor, and inspire a 70-person organization. - Win the trust of skeptics and foster a culture of pragmatic innovation. Benefits - 3 weeks’ vacation and 5 personal days. - Comprehensive Medical, Dental, and Vision benefits starting from your first day of employment. - Employee stock ownership and RRSP/401k matching programs. - Lifestyle rewards. - Remote work and more! Company Description Cayenta is a leading provider of enterprise resource management solutions in the local government, utility, and financial industries. Cayenta’s products, services, and customer relationships provide the foundation for continued innovation and growth. Harris is a leading provider of mission-critical software to the public sector in North America. As a wholly owned subsidiary of Constellation Software Inc. (“CSI”), Harris has become the cornerstone for CSI’s investment in various software verticals.