Medical Director, Medical Affairs, ALS Shionogi & Co LtdMedical Director, Medical Affairs, ALSFlorham Park, NJ$230,000–$280,000 / yearDevelop and maintain excellent working relationships with both US and global Clinical Development, Marketing, and Regulatory functions, ensuring seamless communications and provision of up to date scientifically accurate clinical information to external and internal sources. In collaboration with the VP Medical Affairs and Executive Medical Director, propose strategic medical affairs plans to support programs in the US for pre-approval, marketed, and late development products and compounds with a focus on rare diseases.
Head of Asset in GU Oncology Clinical Development AbbVie IncHead of Asset in GU Oncology Clinical DevelopmentFlorham Park, NJPersonally or through a direct report, leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
Senior Analyst, Regulatory Affairs Oscar HealthSenior Analyst, Regulatory AffairsNew York City, NYRemote$79,488–$104,328 / yearManage the end-to-end administrative lifecycle of each dispute by maintaining real-time updates on project management boards, gathering and redacting member documentation, and uploading supporting evidence to the appropriate portal stages within set regulatory deadlines. Work Location: This is a remote position, open to candidates who reside in: Arizona, Florida, Georgia, Illinois, Iowa, Kansas, Michigan, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas and Virginia.
NewDirector, Regulatory CMC Legend Biotech CorpDirector, Regulatory CMCSomerset, NJ$193,629–$254,137 / yearDemonstrated experience leading late-stage programs and post-approval Regulatory CMC experience supporting commercial products, including lifecycle management, supplements, variations, annual reports, and post-approval commitments. Develop, lead, and execute global CMC regulatory strategies across commercial products and development- stage programs, with primary accountability for late-stage development and post-approval lifecycle management activities.
Regulatory Affairs Specialist, EHS, North America Henry Schein IncRegulatory Affairs Specialist, EHS, North AmericaNY$56,604–$88,443 / yearDevelop and deliver employee environmental, health, and safety (EHS) awareness and training programs to ensure compliance with applicable federal, state, and international regulations, including OSHA, OSHA State Plans (e.g., Cal/OSHA), DOT, IATA, IMO, and EPA requirements. Proficient in Microsoft Office applications, including PowerPoint, and experienced with project management methodologies and tools commonly used in the medical device or pharmaceutical industries.
Associate Director, Biostatistics - Genetic Medicine Regeneron Pharmaceuticals IncAssociate Director, Biostatistics - Genetic MedicineTarrytown, NY$176,100–$287,300 / yearIn this role, a typical day might include: The incumbent will lead efforts of the Biostatistics department with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions. Lead contributions to the preparation of material to be used in regulatory interactions, including drafting analysis plan and reviewing TFLs to be used in regulatory meetings, slides for advisory committee meetings, etc.
NewDirector Research Regulatory Affairs Rutgers The State University of New JerseyDirector Research Regulatory AffairsNew Brunswick, NJUnder Policy 100.3.1 Immunization Policy for Covered Individuals, if employment will commence during Flu Season, Rutgers University may require certain prospective employees to provide proof that they are vaccinated against Seasonal Influenza for the current Flu Season, unless the University has granted the individual a medical or religious exemption. Among the key duties of the position are the following: Provides strategic leadership and oversight for the university's comprehensive research compliance and security programs, reporting to the Assistant Vice President for Research Regulatory Affairs.
Analyst IV, Regulatory Accounting Liberty UtilitiesAnalyst IV, Regulatory AccountingMerrick, NY$95,000–$130,000 / yearProvide final technical review and quality assurance over complex schedules, exhibits, reconciliations, testimony support, regulatory responses, and filing support prepared by Analysts I, II, and III.Interpret and advise on FERC USOA, NARUC guidance, ASC 980 considerations, regulatory assets and liabilities, cost allocations, rate recovery mechanisms, affiliate transactions, and jurisdiction-specific reporting expectations. Principal-level individual contributor responsible for enterprise-level regulatory accounting leadership, technical judgement, and governance over the most complex regulatory reporting, rate-case support, commission data requests, audits, investigations, and compliance matters.
Sr. Staff Clinical Regulatory Scientist VB Spine LLCSr. Staff Clinical Regulatory ScientistAllendale, NJ$130,000–$140,000 / yearAs a Senior Staff Clinical Regulatory Scientist in our Medical Affairs function within the Spine division, you'll lead the evaluation and establishment of clinical evidence strategies for new and existing medical devices - creating and maintaining critical documentation such as Clinical Evaluation Plans and Reports (CEPs/CERs), Post-Market Clinical Follow-up (PMCF) documents, and Summary of Safety and Clinical Performance (SSCP) documents to support global market access and ongoing compliance. At VB Spine, join a high-performing Medical Affairs team where you'll play a critical leadership role in generating and defending the clinical evidence that enables safe, effective spinal technologies to reach patients worldwide.
Associate General Counsel URI CareersAssociate General CounselNew York, New York$116,000–$150,000 / yearIn addition to emergency and transitional housing, URI delivers a robust continuum of Justice Initiatives—including economic empowerment, legal education and advocacy, prevention and youth programming, and abusive partner intervention—designed to break cycles of violence, instability, and poverty. This position will have primary responsibility for certain legal matters and will support other attorneys on other matters, requiring both the ability to handle matters independently as well as the ability to contribute as part of a team.
Senior Manager, Regulatory Affairs, CMC Shionogi & Co LtdSenior Manager, Regulatory Affairs, CMCFlorham Park, NJ$140,000–$170,000 / yearDemonstrated ability to collaborate effectively with cross-functional teams, including R&D, Quality Assurance, Manufacturing, and Commercial teams, to achieve regulatory milestones and drive product development initiatives forward. Work closely with cross-functional teams, including R&D, Quality Assurance, Manufacturing, and Commercial teams, to ensure alignment of CMC regulatory requirements with overall product development plans and timelines.
R&D Sourcing Manager LancesoftR&D Sourcing ManagerParsippany, NJFamiliarity with technology, systems, and software is a plus, as well as experiencing supporting various Development Functions (Clinical Operations, Clinical Data Science, Real-World Evidence, Regulatory Affairs, Patient Safety, Quality and/or Medical Affairs). Excellent communication skills are required, as the role involves regular interaction with internal and external stakeholders, including Clinical Operations, Finance, Legal, Business Conduct, Vendor Management, and Payments.
Sr. Transactions & Structuring Manager - Remote USA Enel SpASr. Transactions & Structuring Manager - Remote USANYRemote$119,800–$179,700 / yearWorking across Development, Engineering, Construction, Operations, Finance, Tax, Regulatory Affairs, and external stakeholders, the Senior Transactions & Structuring Manager drives risk-adjusted value creation and supports strategic decision-making throughout the project lifecycle, from late-stage development through investment approval and execution. Enel Green Power, the Group's renewables arm, has a total capacity of approximately 68 GW and a generation mix that includes wind, solar, geothermal, and hydroelectric power, as well as energy storage facilities, installed in Europe, the Americas, Africa, Asia, and Oceania.
Sr. News & Corporate Researcher Newsmax MediaSr. News & Corporate ResearcherNew York, NY$85,000–$105,000 / yearNews Research to Include: Conduct in-depth research on breaking news, developing stories, current events, public figures, organizations, government agencies, businesses, and other topics relevant to Newsmax programming. Special projects: Conduct rapid research for senior executives on acquisitions, business development opportunities, corporate communications, litigation, presentations, or other priority matters.
Project Lead - RUA92307 IQVIAProject Lead - RUA92307Parsippany, GeorgiaThis role is a step up from the Community Medical Liaison Manager position and is responsible for overall project leadership, client partnership, contract performance, strategic planning, team development, hiring, coaching, mentoring, and operational execution across the national field-based CML team. We are seeking a successful, qualified, and experienced Community Medical Liaison (Regional Social Worker) Project Lead to provide director-level leadership for the IQVIA Community Medical Liaison program supporting Johnson & Johnson Innovative Medicine, Neuroscience .
Clinical Supplies Manager 5 Star RecruitmentClinical Supplies ManagerParamus, New JerseyReview manufacturing, packaging, and labeling Master and Executed Packaging Work Orders/Batch Records (MBR/EBR, Packaging Labeling Approval Forms (PLAF), Labeling Approval Forms (LAF), etc. Assist and support in writing and preparation of regulatory submission documents: drug product and drug substance sections in IND, Annual reports, and Informational amendments.
Lead IT Security Engineer CONMED CorpLead IT Security EngineerNew York, NYRemote$104,134–$163,640 / year5+ years of experience in cybersecurity, with exposure to regulated industries or manufacturing environments, with hands-on experience with SIEM/XDR platforms, endpoint, network, and cloud security and/or vulnerability and incident response programs. Preferred Experience: Strong knowledge of Security frameworks (NIST, ISO 27001), Identity and access management& network segmentation and Zero Trust principles.
Director, Corporate Accounts Cleerly IncDirector, Corporate AccountsNY$175,000–$225,000 / yearPartner with Client Success Managers, Sales Leadership, Implementation, Marketing, Market Access, Sales Operations, Legal, and other internal stakeholders to ensure successful launch, adoption, utilization, QBRs, and account expansion after enterprise contracts are signed. Develop strategic account plans for each priority IDN, including executive sponsors, clinical champions, financial buyers, contracting pathway, competitive dynamics, current CCTA volume, expansion potential, and local pull-through opportunities.
US Senior Medical Director, Neurology SanofiUS Senior Medical Director, NeurologyMorristown, NJ$206,250–$297,916.66 / yearMain Responsibilities: Provide strategic leadership to the US Medical Affairs Next Gen Immunology team (Medical Directors, Medical Science Liaison Managers, and Medical Science Liaisons) by cultivating a culture of teamwork and collaboration to ensure the delivery of key priorities while attracting, developing, and retaining top talent. Develop strategy and tactics for an integrated Medical Plan encompassing Medical Science Liaisons, Medical Education, Medical Communications and Publications, Health Outcomes, Safety, and Clinical Research (Phase IIIB-IV and Investigator Sponsored Trials) across the neurology pipeline.
Scientific Partnership Medical Director BeOne Medicines AGScientific Partnership Medical DirectorNY$299,800–$369,800 / yearThe role collaborates closely across a matrix of internal functions including: NAMA, R&D, Market Access, Clinical Operations, Field Medical Directors (FMDs), Regional Medical Science Liaisons (RMSLs), Home Office Medical (HOM), Global Medical Affairs (GMA), HEOR/RWE, and Franchise/Commercial Leadership. Lead through influence across BeOne Medicines' internal matrix partners - including FMDs, RMSLs, HOM, GMA, HEOR/RWE, R&D, Market Access, Clinical Operations, and Franchise/Commercial Leadership - to deliver coordinated enterprise solutions at assigned health systems.