Regulatory Product Lead, Health Authority Outcomes
6084-Janssen Research & Development, LLC Legal Entity
6084-Janssen Research & Development, LLC Legal Entity is seeking a Senior Manager for Regulatory Affairs in Spring House, PA. This hybrid role encompasses global responsibilities to oversee digital products that enhance interactions with health authorities. Candidates should have at least 8 years in the pharmaceutical or healthcare sector and strong Regulatory Affairs expertise to be successful. The position offers opportunities for collaboration with cross-functional teams and focuses on improving operational efficiency and quality through strategic product initiatives. #J-18808-Ljbffr 6084-Janssen Research & Development, LLC Legal Entity
- ...Client Medicine: We believe health is everything. Our strength... ...informs clinical development, regulatory strategy, and healthcare... ...strategy, or health economics and outcomes research (HEOR). •... ...regulatory submissions or health authority interactions. • Familiarity...RegulatoryRemote work
- Senior Manager, Regulatory Affairs Business Outcomes Delivery Location: Spring House, PA. Hybrid... ...improvement of digital products that streamline interactions with health authorities. Sets product vision,... ...inspection readiness. Experience leading strategic product...RegulatoryLocal area
$94k - $151.8k
...& Johnson, we believe health is everything. Our strength... ...Function: Technology Product & Platform Management... ...experience, and operational outcomes. The Technical Product... ...privacy, security, and regulatory compliance expectations... .... Work with the Lead Engineer to assess solution...RegulatoryFull timeLocal areaImmediate start- ...pipeline Rheumatology products/indications,... ..., and dissemination. Lead and maintain the Integrated... ...focusing on efficacy, outcomes, safety, and adverse... ...protocol development, regulatory communications, investigator... ...and engage with health authorities, particularly the US...RegulatoryWork at officeLocal areaRemote work2 days per week
- Role Overview As an External Quality Drug Product Lead, you will be reporting to the Specialty... ...details. You provide quality and regulatory support to ensure clinical/commercial manufacturing... ...the external supplier to ensure that outcomes from quality and manufacturing systems—...RegulatoryLocal area
- ...for drug substance and drug product tech transfer and manufacturing... ...products. MSAT Drug Product Lead ensures that formulation, fill... ...Fit to Plant evaluation Author protocols to support GMP manufacturing... ...capabilities Support client regulatory filing as necessary...Regulatory
- ...Operations Division. The MSAT Process Engineer - Product Lifecycle will serve as the technical lead for technology transfer, commercial readiness... ...matter expert (SME) for material sciences, author relevant sections of regulatory filings, and establish robust Standard...RegulatoryShift work
- ...decisions, and improve patient outcomes—starting in oncology and... ...teams partner with the world’s leading pharmaceutical companies, providers... ...how clinical development, regulatory, and commercialization... ...experts on innovative, high‑impact products that directly improve patient...RegulatoryLocal area
$70.92 per hour
...coordinating global Clinical Outcome Assessment (COA)... ...endpoints to support regulatory submissions, reimbursement... ...to support the product strategy. Primary activities... ...those from regulatory authorities and reimbursement... .... Education: • PhD in Health Services Research, Statistics...RegulatoryWork experience placement$173.2k - $272.6k
...research, we deliver innovative health solutions that advance the... ...a subject matter expert, and leads cross-site initiatives to drive... ...and external sites. Identify regulatory requirements, cGMP... ...and industry trends. Develop, author, and maintain divisional quality...RegulatoryRelocationVisa sponsorshipFlexible hoursShift work- The Product Safety Head is responsible for safety oversight... ...Officers (MSOs) leading product safety... ...complex development plans, regulatory submissions, and post‑... ...(e.g., Adhoc reports, Health Hazard Evaluations, Clinical... ...in regulatory authority interactions regarding...Regulatory
$231.9k - $365k
...to deliver innovative health solutions that advance... ...help us deliver clinical product information, educational... ...better patient outcomes in their communities. Role... ...experienced sales leader to lead an immunology sales... ...business practices, and regulatory requirements. Qualifications...RegulatoryFor contractorsNight shift$180k - $200k
...best-in-class Global Health Product & Platforms team, the... ...aligned to business outcomes and growth goals,... ...managers, technical leads, and developers. This... ...cloud transformation, Regulatory/compliance requirements... ...Influencing change as an authority, driving...RegulatoryLocal area- ...Operations ICON plc is a world-leading healthcare intelligence and... ...time, and in compliance with regulatory requirements. Responsibilities... ...and drive successful outcomes. Willingness to travel as required... ...leave entitlements A range of health insurance offerings to suit you...RegulatoryFlexible hours
$104.5k - $156k
...seeking Psychiatric Mental Health Nurse Practitioners to... ...to optimize patient outcomes Maintain accurate... ...compliance with all regulatory requirements We are... ...care and industry leading solutions to our most... ...increase over time based on productivity and performance in the...RegulatoryMinimum wageWork experience placementWork at officeLocal areaRelocation packageFlexible hours- ...Jefferson University and Jefferson Health - Center City Collaborates with... ...management team on risks and regulatory requirements. The RCO serves as the administrative lead of the regional Corporate Compliance Committee and is authorized to implement all necessary actions...RegulatoryLocal areaShift work
$58.8k - $105k
...treat a wide variety of mental health conditions that reflect the... ...ensuring compliance with all regulatory requirements We are committed... ...care and industry leading solutions to our most vulnerable... ...disparities and improves health outcomes — an enterprise priority...RegulatoryMinimum wageFull timeWork experience placementWork at officeLocal areaFlexible hours3 days per week$58.8k - $105k
...treat a wide variety of mental health conditions that reflect the... ...ensuring compliance with all regulatory requirements We are committed... ...care and industry leading solutions to our most vulnerable... ...disparities and improves health outcomes - an enterprise priority reflected...RegulatoryMinimum wageFull timeWork experience placementLocal areaRemote workFlexible hours$190.8k - $300.3k
...Implementation (V&I) Outcomes Research is responsible... ...in‑line and pipeline products. The role supports value... ...agencies, and health systems worldwide, executing... ...input into clinical, regulatory, payer/access, marketing... ...strategies. Design studies; author protocols; develop...RegulatoryFor contractorsLocal areaWorldwide$190.8k - $300.3k
...Implementation (V&I) Outcomes Research resides in the... ...in‑line and pipeline products, meeting the needs of... ...payers, policymakers, health technology assessment... ...input into clinical, regulatory, payer/access, marketing... ...strategies. Design studies, author protocols, develop...RegulatoryFor contractorsLocal areaWorldwide- ..., the Director will lead protocol development... ...real‑world evidence, health economics and outcomes research,... ...the knowledge of J&J products for autoimmune diseases... ...the preparation of regulatory submissions and interactions... ...with Health Authorities (particularly the FDA...RegulatoryWork at officeLocal areaRemote work2 days per week
$199k - $343.85k
...'s toughest brain health challenges including... ...Assists Regulatory Affairs in determining... ...actions or health authority reporting related... ...study conduct or outcome May act as a medical... ...written results of product research, in concert... ...and expertise in leading and managing in a...RegulatoryLocal areaImmediate start$40 - $46 per hour
...outpatient), promoting overall health and supporting the healing... ...care team to optimize client outcomes and integrate nutrition seamlessly... ...health records (EHR) and regulatory standards relevant to addiction... ...Consultants LLC is a leading Registered Dietitian Nutritionist...RegulatoryPart timeFlexible hours$150k - $258.75k
...& Johnson, we believe health is everything. Our strength... ...Function: Technology Product & Platform Management... ...seeking a Director to lead our Content Products and... ...prioritized, funded, measurable outcomes. Make AI the operating... ...Affairs, Legal, Regulatory, Architecture, and IT,...RegulatoryFull timeLocal areaImmediate start- ...management client! Join a leading therapy organization with 30+... ...team members to ensure quality outcomes Maintain documentation to meet all regulatory requirements Ensure all... ...patients in skilled nursing, home health, senior living, outpatient, and...RegulatoryDaily paidContract workLocal area
- ...seeking an Associate Principal Scientist specializing in Clinical Outcome Assessment. This pivotal role involves coordinating global... ...strategies for Patient-Reported Outcomes and ensuring alignment with regulatory requirements. You will collaborate with cross-functional teams...Regulatory
$3,500 - $4,000 per day
...compassionate, and predictable clinical outcomes. The Anesthesiologist will collaborate closely... ...following practice emergency protocols; lead management of airway or anesthesia-... ...standards. Ensure adherence to all regulatory guidelines, including OSHA, HIPAA, ADA sedation...RegulatoryDaily paidWork at office- ...accordance with client, company and regulatory guidelines. This position is... .... Within granted authority, establishes appropriate loss... ...between allocated expense and loss outcome. Comply with Special... ...a strong ability to actively lead or participate in meetings, presentations...Regulatory
$122k - $212.75k
...& Johnson, we believe health is everything. Our strength... ...Function: Technology Product & Platform Management... ...solutions. This role leads a team responsible for... ...feasibility, and regulatory requirements. The Senior... ...plans. Balance business outcomes, user experience,...RegulatoryFull timeLocal areaImmediate start- ...seeking a Senior Manager, North America Regulatory Liaison. This hybrid role based in Spring House, PA is focused on leading regulatory strategies and execution for Immunology... ...to ensure high-quality interactions with Health Authorities. Ideal candidates will have at least 8...Regulatory
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