- Larimar Therapeutics (Philadelphia, PA)
- …a key member of project teams and the role reports to the Regulatory Affairs Senior Director. Job Duties/Responsibilities: Larimar Team Membership The Director ... of CMC Regulatory Affairs will be a key member of the regulatory , clinical project, and technical operations (cross-functional) teams who will manage CMC … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Microbial Process Operations (MPO) Team is seeking a Senior Principal Scientist with expertise in microbial process development for the production ... biomolecules, including novel biotherapeutics, vaccines, and engineered enzymes.As a senior scientific leader, the successful candidate will shape strategy, drive… more
- Merck & Co. (Rahway, NJ)
- …Sciences, Process Design, Process Hazard Analysis (PHA), Process Optimization, Proper Documentation , Regulatory Compliance, Regulatory Requirements {+ 4 ... MES, SCADA, DCS, and OEM systems-Work with process development teams on technical development and the testing of new technologies, trialing new automation… more
- Genmab (NJ)
- …a fit? Then we would love to have you join us!The RoleThe Senior Manager, Clinical Programming is responsible for the establishment, governance, and integrity of ... study or portfolio-level SDTM datasets are in compliance with CDISC and regulatory submission requirements, reviews study submission data packages to ensure quality… more
- Takeda Pharmaceutical (Social Circle, GA)
- …and validation. Emphasis is on ensuring accuracy and integrity on validation documentation meets regulatory guidelines and industry standards. Write protocols ... Final documents are archived and may be included in or support regulatory submissions, and made available during internal and external regulatory /compliance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Heritage Bank (Portland, OR)
- …exciting opportunity to join our organization! We are seeking a Credit Review Officer/ Senior to join our Credit Review team. The credit review officer is responsible ... ensure that acceptable credit standards are maintained, and loans and related documentation adhere to the Bank's policies, procedures, guidelines, and regulatory … more
- Reed Smith LLP (Pittsburgh, PA)
- …structure make us the go-to partner for complex disputes, transactions and regulatory matters. Our team of 3,000 people (including more than 1,600 lawyers) ... progress for our clients, for ourselves and for our communities. Position Summary The Senior Solutions Engineer in Client Development will serve as a senior … more
- AdaptHealth LLC (Philadelphia, PA)
- …ensuring your CV and skills are a good match. Position Summary: The Senior Internal Auditor - Business Systems is responsible for supporting and executing internal ... while developing expertise in control evaluation, risk assessment, and regulatory compliance frameworks. Essential Functions and Job Responsibilities Audit Planning… more
- CMA CGM (America) LLC (Arlington, VA)
- …policies and procedures, conducting risk assessments, and ensuring compliance with regulatory requirements. The Superintendent, Technical (AML) works closely ... ID: 560509 Location: Arlington, VA, US Superintendent, Technical (AML) Delivering Excellence Across the Seas APL Maritime, headquartered in Arlington, VA, is a… more
- Insmed Incorporated (NJ)
- …of regulatory submissions including INDs, NDAs/MAAs, and other required documentation . Ensuring compliance with ICH, FDA, EMA, PMDA and other international ... for patients with serious diseases. Reporting to the SVP, Technical Operations, you will lead all Chemistry, Manufacturing, and...activities for the company's small molecule pipeline. As a senior leader, you will oversee drug substance and drug… more
- Insmed Incorporated (NJ)
- …you?About the Role:The Director, EHS (Environmental, Health, and Safety) isa senior -level role responsible for creating and implementing programs that ensure ... workplace safety, regulatory compliance, and environmental protection for all Insmed locations.Key...audits and surveys, analyze results, and provide reports to senior management and other stakeholders.Advise senior leaders… more
- Insmed Incorporated (NJ)
- …role will manage cross-functional teams and ensure compliance with regulatory requirements while maintaining operational excellence. The Executive Director, ... building and protecting secure digital environments. The ideal candidate combines deep technical expertise with a proven ability to communicate complex risks in… more
- Cipla (Hauppauge, NY)
- …and analyze all data, write final reports and obtain approvals. Review technical documentation such as batch records, SOPs, calibration records, preventive ... English language communication skills verbally, written, and interpersonally. Must possess strong documentation and technical writing skills, and able to apply… more
- BHE GT&S (Jacksonville, FL)
- …has an exciting career opportunity as an Associate LNG Technician/LNG Technician/ Senior LNG Technician at our Jacksonville, FL location. RESPONSIBILITIES The ... Associate LNG, Technician, or Senior Technician reports directly to the Plant Manager and...Performs all duties applying safety protocols and adhering to regulatory mandates. Other duties as assigned. LNG Technician Applied… more
- Merck & Co. (Rahway, NJ)
- …and documentation to meet program deadlines. - Authoring and reviewing internal technical reports, sections of regulatory filings ( eg, IND , BLA ) ... at its Rahway, New Jersey research facility. The Principal Scientist is a senior scientific role tasked with working closely with the group Director to define… more
- Repligen (Waltham, MA)
- …Audit, and external auditors.Communicate risks, findings, and recommendations to both technical and non- technical stakeholders, including senior ... strengthen Repligen's control environment.ResponsibilitiesKey ResponsibilitiesLead the planning, execution, and documentation of SOX IT testing activities, partnering closely with… more
- Reed Smith LLP (Pittsburgh, PA)
- …structure make us the go-to partner for complex disputes, transactions and regulatory matters. Our team of 3,000 people (including more than 1,600 lawyers) ... for the firm's growing portfolio of AI-enabled products. Reporting to the Senior AI Product Manager, this role supports adoption and enablement efforts through… more
- Aptyx (Charlotte, NC)
- …catheters. This role is intended for candidates at the Engineer II through Senior Engineer level who are comfortable working hands on, driving technical ... in collaboration with operations, tooling, and quality teams. Prepare documentation including design history file elements, risk management documents, protocols,… more
- Agile IT (San Diego, CA)
- …tools in Azure and Microsoft 365 to meet CMMC Level 2 and other regulatory requirements. Youa€ (TM) ll spend your days hunting for threats, fine-tuning defenses, and ... configuration changes at scale, thereby saving time and reducing human error. Documentation & Compliance Evidence: Maintain comprehensive documentation for all… more
