Role Description The Scientist III CMC is a senior-level contributor responsible for leading regulatory strategy and execution for pre-approval, post-approval changes and lifecycle management activities across client Rx and non-Rx programs. Operating in a client-facing, consultant capacity, this role provides strategic guidance on complex regulatory submissions, authors and reviews high-impact documentation, and drives alignment across cross-functional teams to ensure successful regulatory outcomes. The individual is expected to work independently, manage competing priorities, and deliver high-quality, submission-ready content aligned with global regulatory requirements, while also supporting the development of junior staff. Location: Remote Responsibilities - Develop regulatory strategy and execution plan for pre-approval, post-approval changes and lifecycle management activities. - Serve as an author strategist, defining document structure, content strategy, and submission approach for complex regulatory dossiers. - Author, review, and approve high-quality regulatory documents (e.g., supplements, variations, responses to health authority queries) ensuring scientific and regulatory rigor. - Provide strategic input on CMC and lifecycle change assessments, including regulatory risk evaluation and submission pathways. - Collaborate with cross-functional stakeholders (CMC, Quality, Clinical, Supply Chain) to drive alignment on regulatory strategy and ensure accurate and complete submission content. - Act as a primary regulatory point of contact for assigned client projects, providing guidance and maintaining strong client relationships in a consultant role. - Lead timeline planning, tracking, and execution of regulatory deliverables to meet critical milestones. - Perform advanced document quality control, formatting, and publishing in compliance with global regulatory standards using tools such as MS Office and Adobe Acrobat. - Mentor and provide day-to-day guidance to junior regulatory staff, supporting their technical development in regulatory strategy, authoring, and submission processes. - Review, edit, and provide feedback on work produced by junior team members, ensuring accuracy, consistency, and compliance with regulatory and client standards. - Promote best practices in document preparation, quality, and regulatory compliance across the team. - Support regulatory inspections, audits, and responses related to lifecycle management activities, as needed. - Ensure an established level of billable hours per fiscal year. Qualifications - Advanced experience in support of pharmaceutical product development, quality assurance and/or CMC regulatory affairs, highly preferred. - Proactive, self-motivated, and able to work independently in a client-facing role. - Knowledge and experience with cGMP regulations and ICH guidance. - Proficiency with Health Authority regulations (FDA, EMA, Health Canada, etc.). - Experience with writing global regulatory applications in CTD format. - Ability to manage multiple tasks and meet deadlines in a dynamic environment. - Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). - Proficiency with Adobe Acrobat for document editing, formatting, and publishing. - Team-oriented mindset with the ability to collaborate across functions. - Understanding and application of scientific principles and techniques used in pharmaceutical product development. - MS/BS in Chemistry, Analytical Chemistry, or related life sciences. - Strong attention to detail and organizational skills. - Effective written and verbal communication skills. Requirements - Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects. - May contribute to the development of policies and procedures. - Works on complex projects of large scope. - Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives. - Completes work independently with attention to detail. - Receives general guidance on new projects. - Work reviewed for purpose of meeting objectives. - Mentor to less experienced staff. - Support client projects as a consultant. - Work remotely from home office. - Adaptability and responsiveness to changing project priorities. Benefits - Medical, dental and vision coverage. - Paid time off plan. - Health savings account (HSA). - 401k savings plan. - Access to wages before pay day with myFlexPay. - Flexible spending accounts (FSAs). - Short- and long-term disability coverage. - Work-Life resources. - Paid parental leave. - Healthy lifestyle programs.

Role Description The Scientist I - CMC supports regulatory activities for pre-approval, post-approval changes, and lifecycle management across client Rx and non-Rx products. Working as a consultant, this role assists in the preparation, review, and coordination of regulatory documentation, while ensuring alignment with applicable regulatory requirements and client expectations. The individual will collaborate closely with cross-functional teams and contribute to the timely delivery of high-quality regulatory submission content. - Support the development, authoring, and compilation of regulatory documentation related to post-approval changes and lifecycle management activities. - Assist as an authoring strategist by organizing and maintaining submission-ready documents in accordance with US FDA and global regulatory requirements (EMA, NMPA, ANVISA, PMDA, HC, TGA, etc). - Collaborate with cross-functional teams (e.g., CMC, Quality, Manufacturing, and Supply) to gather and verify required information for regulatory submissions. - Ensure documentation consistency, accuracy, and compliance with internal standards and client expectations. - Track and manage document timelines and deliverables to support regulatory milestones. - Maintain clear and proactive communication with client stakeholders while operating in a contractor capacity. - Ensures an established level of billable hours per fiscal year. Qualifications - Bachelor's degree in related field, or equivalent work experience (Pharma QA, QC, Analytical Development), preferred. - Familiarity with core CMC concepts (e.g., manufacturing, control strategy, change management) and general awareness of post-approval variation requirements across major health authorities (e.g., FDA, EMA, NMPA, PMDA, ANVISA, TGA, Health Canada) is preferred. - Understanding and application of scientific principles and techniques used in pharmaceutical product development. - Knowledge and experience with cGMP regulations and ICH guidance. - Experience with writing global regulatory applications in CTD format highly preferred. - Basic proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). - Working knowledge of Adobe Acrobat for document editing, formatting, and publishing. - Proactive, self-motivated, and able to work independently in a client-facing role. - Strong attention to detail and organizational skills. - Effective written and verbal communication skills. - Ability to manage multiple tasks and meet deadlines in a dynamic environment. - Team-oriented mindset with the ability to collaborate across functions. Requirements - Applies foundational CMC and regulatory concepts to support project deliverables with attention to quality and detail. - Contributes to project activities with increasing autonomy, proactively seeking guidance when needed. - Interprets and applies established procedures to address routine technical and regulatory questions. - Demonstrates a strong learning mindset, building CMC and global regulatory knowledge (including post-approval lifecycle management) through hands-on project work. - Effectively manages assigned tasks and deadlines in a remote setting, showing self-motivation and accountability. - Adapts to evolving project priorities and supports multiple client needs as part of a consulting environment. - Communicates clearly and collaborates with team members to ensure alignment and progress on deliverables. - Supports client projects by delivering high-quality work products and developing regulatory acumen over time. Benefits - Medical, dental and vision coverage. - Paid time off plan. - Health savings account (HSA). - 401k savings plan. - Access to wages before pay day with myFlexPay. - Flexible spending accounts (FSAs). - Short- and long-term disability coverage. - Work-Life resources. - Paid parental leave. - Healthy lifestyle programs.

Role Description Responsible for providing per-diem clinical neuropsychology expertise in support of clinical research within an outpatient behavioral health and academic medical setting. The Neuropsychologist advances the program's research mission by: - Leading and contributing to the preparation of scientific manuscripts. - Overseeing research assistants on clinical research projects. - Applying expertise in brain–behavior relationships across medical populations, including medical oncology and epilepsy. - Partnering with principal investigators (PIs) and collaborating with interdisciplinary teams. - Mentoring junior research staff and ensuring scientific rigor and continuity across active projects. Qualifications - Lead and contribute to the writing, editing, and submission of scientific manuscripts for peer-reviewed publication. - Oversee, mentor, and supervise research assistants supporting clinical research projects, ensuring quality, consistency, and adherence to study protocols. - Apply expertise in brain–behavior relationships to clinical research involving medical populations, with emphasis on medical oncology and epilepsy. - Conduct and/or interpret neuropsychological assessments in support of research and clinical aims as needed. - Contribute to study design, data interpretation, and the presentation and dissemination of findings. - Collaborate with psychologists, psychiatrists, neurologists, oncologists, case managers, nurses, and other care and research providers to coordinate project activities and referrals. - Maintain accurate and timely research and clinical documentation in compliance with organizational, IRB, and regulatory standards. - Participate in research team meetings, case consultations, and project planning activities as needed. - Assist the program director in improving, expanding, and developing new research initiatives, materials, and/or services. - Comply with all federal, state, and local laws and regulations regarding patient care, research, and privacy (e.g., HIPAA, IRB, licensing standards). - Perform other duties as assigned. - Comply with all policies and standards. Requirements - Remote Type: Remote - Work Location: 15 New Chardon Street - Scheduled Weekly Hours: 0 - Employee Type: Per Diem - Work Shift: Day (United States of America) EEO Statement 1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

• Design, implement, and train novel deep learning models on large-scale GPU clusters. • Prototype new architectures and algorithms for enterprise data, such as tabular, relational, and graph-structured data. • Stay current with AI research, apply relevant breakthroughs, and advise on internal AI strategy. • Partner with engineering, product, and design teams to turn research into functional, production-ready features.