Senior Scientist, Regulatory Submissions & SDTM
Scorpion Therapeutics
Scorpion Therapeutics is looking for a qualified professional to oversee quality management of submission data for worldwide regulatory applications related to drug and vaccine clinical development projects in Rahway, New Jersey. The ideal candidate will have a background in Computer Science or related fields, along with significant SAS programming experience. Strong interpersonal and project management skills are crucial for success in this role. Responsibilities include preparing for PreNDA meetings, collaborating with various stakeholders, and guiding teams through submission deliverables. #J-18808-Ljbffr Scorpion Therapeutics
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior Scientist, Regulatory Submissions & SDTM in Rahway, NJ vacancy
- Responsibilities Provide oversight and quality management of submission data standard deliverables for worldwide regulatory application submissions for drug and vaccine... ...21 Enterprise). Up-version activities to specific SDTM versions. Participate in industry teams/...SeniorRegulatoryWorldwide
- ...responsibility for process characterization, technology transfer, and validation of large molecule drugs, ensuring compliance with regulatory submissions. The ideal candidate will have experience in large molecule process development, technical documentation skills, and the...SeniorRegulatory
- MSD Malaysia in Rahway, NJ, is seeking a Senior Scientist for Cell Culture Sciences to drive strategy and technical direction for biologics... ...oversight of cell culture processes, and managing regulatory submissions. The ideal candidate will have a relevant degree and...SeniorRegulatory
- ...and process changes to improve yield and/or robustness. Author regulatory and technical documentation for process Tech Transfer and... ...Experience authoring technical documentation supporting regulatory submissions for product licensure. Strong communication and people skills...SeniorRegulatory
$117k - $184.2k
Job Description We are seeking a Senior Scientist to join the Process Analytical Technologies (PAT) team within Analytical Enabling... ...validation packages for PAT methods; contribute content for regulatory submissions. Education B.S. in chemistry, biochemistry, biotechnology...SeniorRegulatory- Job Title Senior Scientist, Cell Culture Sciences, Biologics Drug Substance Commercialization... ...process development, characterization, and regulatory filing activities. Lead risk... ...qualification. Support writing of IND, MAA, BLA submissions and coordinate inspections with FDA,...SeniorRegulatory
$117k - $184.2k
Senior Scientist - Pharmaceutical Analytical Sciences The Pharmaceutical Analytical Sciences group has an opening for a Senior Scientist... ...analytical methods and tools of the future. Author regulatory submission documents across the project life‑cycle and respond to agency...SeniorRegulatoryFor contractors$117k - $184.2k
...division, quantitative scientists work with other... ...discovery, development, regulatory approval, manufacturing... ...except oncology. The senior statistical programmer... ...programming code for regulatory submissions, including analysis/... ...Experience in CDISC SDTM and ADaM standards....SeniorRegulatoryFor contractorsLocal area$77.4k - $110.3k
Senior Scientist I, Regulatory Affairs, L'Oréal Research & Innovation - Clark, New Jersey Hello, we’re L’Oréal, we're not just building brands;... ...review of regulatory compliance documentation, ensuring every submission is accurate, complete, and reflective of our commitment...SeniorRegulatoryPermanent employmentFull timeWork experience placementSummer workWork at officeFlexible hours3 days per week$117k - $184.2k
...Development division, quantitative scientists, in partnership with other... ...the discovery, development, regulatory approval, manufacturing and... ...modular analysis and reporting and submission standards and tools that can... ...and understanding of CDISC SDTM and ADaM analysis dataset...SeniorRegulatoryFor contractorsRelocationVisa sponsorshipFlexible hoursShift work- ...Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities... ...including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior...SeniorRegulatory
Merck & Co. Inc
Rahway, NJ4 days ago - Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research activities... ...to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and puSeniorRegulatory
Merck & Co. Inc
Rahway, NJ4 days ago $117k - $184.2k
## Senior Scientist, Analytical Research and DevelopmentApplyremote type: Not Applicablelocations... ..., Quality Assurance, and CMC Regulatory Affairs to solve technical issues, offer... ...technical documentation including regulatory submissions.* Additional responsibilities as...SeniorRegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift workAfternoon shift$173.2k - $272.6k
...MSD Malaysia in Rahway, NJ is seeking a Principal Scientist to drive process engineering for oral solids dosage forms. This role involves... ...possess extensive experience in drug product processing and regulatory knowledge, along with strong communication and leadership...SeniorRegulatoryMSD Malaysia
Rahway, NJ1 day ago- ...The role requires 6-8 years of experience in the clinical domain, with strong expertise in SDTM and SAS programming. You will collaborate with biostatisticians, ensuring regulatory compliance and performing peer reviews. The ideal candidate has a proven track record in...SeniorRegulatory
- ...Process Research & Development. This role involves leading upstream process development for biologics and ensuring compliance with regulatory standards. The ideal candidate holds a Ph.D. or Master's with extensive experience in bioengineering, demonstrating exceptional...SeniorRegulatory
$173.2k - $272.6k
...Development division, quantitative scientists, in partnership with other... ...the discovery, development, regulatory approval, manufacturing, and... ...analysis and reporting and submission standards and tools that can... ...knowledge and understanding of CDISC SDTM and ADaM analysis dataset...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursMerck & Co. Inc
Rahway, NJ10 hours ago$117.15k - $141.96k
Position Summary Senior Scientist (technical expert) supporting the Cellular Therapy product... ...transfer and method validation per global regulatory requirements. Steward bioassay/flow... ...Support analytical sections of regulatory submissions; respond to health authority questions...SeniorRegulatory$117k - $184.2k
...company is currently seeking an exceptional individual for a Senior Scientist position within the Supply Analytical Sciences (SAS) -... ..., and responsive supply of materials Understand the global regulatory and business environment related to pharmaceutical API and drug...SeniorRegulatoryFor contractorsRelocationVisa sponsorshipFlexible hoursShift work- ...Merck & Co. is seeking a Senior Statistical Programmer in Rahway, NJ. This position involves preparing high-quality programming deliverables, analyzing and transforming data for global stakeholders. Candidates should hold a BA/BS or MS in a relevant field with significant...SeniorRegulatory
Merck & Co. Inc
Rahway, NJ1 day ago $117k - $184.2k
...division, quantitative scientists, in partnership with... ...discovery, development, regulatory approval,... ...except oncology. -The senior statistical programmer... ...programming code for regulatory submissions including analysis/modeling... ...Experience in CDISC SDTM and ADaM standards...SeniorRegulatoryFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- ...Katalyst CRO in Edison, NJ is seeking a qualified individual to lead publishing activities for regulatory submissions. The ideal candidate has a Bachelor’s or Master’s degree in Pharmacy or Life Sciences, with 5-10 years of experience in eCTD/NeeS publishing. Responsibilities...SeniorRegulatory
Katalyst CRO
Edison, NJ10 hours ago $117k - $184.2k
...Job Description Support the Lead Epi Scientists by providing overall operational... ...document adherence to internal, external, and regulatory compliance requirements Collaborate... ..., internal review process, and journal submissions Conduct literature reviews Active...SeniorRegulatoryFull timeContract workFor contractorsWork experience placementInterim roleLocal areaRelocationVisa sponsorshipFlexible hoursShift work$282.2k
Job Description The Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities... ...including: study design, placement, monitoring, analysis, regulatory reporting, and publication. Specifically, The Senior...SeniorRegulatoryFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$117k - $184.2k
...Job Description Job Title: Senior Scientist, Cell Culture Sciences, Biologics Drug Substance... ..., process characterization and regulatory filing activities to ensure a smooth and... ...performance qualification, and/or regulatory submissions. CMC RA : Experience supporting/...SeniorRegulatoryFull timeFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work$117k - $184.2k
...company’s renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state... ...methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and...SeniorRegulatoryFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$117k - $184.2k
...clinical/scientific execution of clinical protocol(s). Serves as the lead clinical scientist on the clinical trial team. Collaborates with the Medical Writer on clinical/scientific and regulatory documents. Partners with Study Manager on study deliverables. Participates in...SeniorRegulatoryFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- ...requires strong SAS programming skills, experience with SDTM/ADaM specifications, and knowledge of regulatory guidelines. Responsibilities include overseeing... ...collaborating with study teams. This role operates at a mid-senior level in the pharmaceutical manufacturing industry,...SeniorRegulatoryContract work
$119.1k - $187.5k
...biggest investors in Research & Development. We are seeking a Senior Scientist to join our Digital Insights team within the Development... ...Author technical documents and reports according to current regulatory requirements and business practices. Working across teams in...SeniorRegulatoryFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$75.2k - $124.1k
...via research and/or position development, and documentation. Lead the preparation and review of moderately complex tax/accounting regulatory and tax compliance with limited supervision. Perform and document research and analysis on related accounting and tax issues....SeniorRegulatorySummer holidayFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Scientist, Regulatory Submissions & SDTM. Be the first to apply!
Related searches
- lab scientist Rahway, NJ
- principal scientist Rahway, NJ
- research scientist - biology Rahway, NJ
- senior principal scientist Rahway, NJ
- drug safety scientist Rahway, NJ
- machine learning scientist Rahway, NJ
- cell culture scientist Rahway, NJ
- analytical scientist Rahway, NJ
- scientist immunology Rahway, NJ
- downstream processing scientist Rahway, NJ