- Repligen (Waltham, MA)
- …Join us!IT Manager , SOX & ITGC ComplianceWe are seeking an experienced IT Manager , SOX & ITGC Compliance to lead the design, implementation, and ongoing ... reporting and key digital systems. This role drives the ITGC audit program , advises on risk mitigation strategies, and partners closely with Internal Audit,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …have a strong background in documentation management, process oversight, and regulatory compliance within the pharmaceutical or biotechnology industry. ... 7+ years of experience in documentation management, quality assurance, or regulatory compliance within the pharmaceutical or biotechnology industry Strong… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …audits effectively. Ensure the internal systems auditing program fulfills regulatory requirements performs audits, identifies compliance issues and trends, ... audits, remediations implemented and CAPAs pending.Support Risk Mitigation programs to ensure compliance to regulatory guidelinesEnsure up to date audit CAPA… more
- Genmab (NJ)
- …Data Tabulation Model (SDTM) standards that support the scientific need of a study/ program while ensuring quality, consistency and compliance to CDISC standards ... regulations, and processes Ensures study or portfolio-level SDTM datasets are in compliance with CDISC and regulatory submission requirements, reviews study… more
- Insmed Incorporated (NJ)
- …coordinates the management and execution of all clinical trial activities in compliance with GCP and relevant regulatory guidelines.Detailed management and ... for the future of science, we're in. Are you?About the Role:The Clinical Trial Manager will be responsible for the management and oversight of phase I-IV clinical… more
- Insmed Incorporated (San Diego, CA)
- …lifecycle management and remain in a validated state per associated SOPs, regulatory and security requirements. \tEnsure compliance and operational efficiency of ... and resolution guidance. Train, coach, and mentor GxP system owners. Provide CSV program trainings, lunch and learns and guidance to new stakeholders as well as… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. The Manager Product training is responsible for the following:- Developing and implementing training programs ... creating, developing, and administering in whole or in part, a training program which includes sales techniques and presentations, product and product applications… more
- Insmed Incorporated (NJ)
- …in a validated state (eg SDLC, IT Change Control) per associated SOPs, regulatory and security requirements. \tEnsure compliance and operational efficiency of ... support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)Generous paid time off policies, fertility and family-forming benefits,… more
- Cipla (Hauppauge, NY)
- … standard. Review of the batch records (manufacturing and packaging) to ensure compliance with GMP, regulatory standards, and internal procedures. Ensure that ... and audit trail documentation are properly stored, maintained, and accessible in compliance with internal and regulatory requirements for record retention.… more
- Syner-G BioPharma Group (Boston, MA)
- …and hands-on expertise to streamline operations, enhance quality systems, and ensure regulatory compliance , empowering our clients to navigate complexity and ... inspections, maintain documented records, and be on-call for emergencies, ensuring compliance with regulatory requirements and GMPs. Effective communication and… more
- Cipla (Hauppauge, NY)
- …and verify artwork proofs for printed packaging materials to ensure accuracy, compliance with regulatory requirements, and alignment with product specifications. ... and regulatory requirements. Participate in internal audits and ensure compliance with warehouse quality standards. Ensure cleaning of the printed packaging… more
- Formation Bio (New York, NY)
- …programs and clinical studies. Collaborate with cross-functional teams (Clinical Development, Regulatory , Program Management, etc.) to shape and refine Clinical ... clinical programs across various therapeutic areas and phases (I-IV), ensuring compliance with global regulations, delivering on timelines and budgets, and driving… more
- Insmed Incorporated (NJ)
- …strategy for Patient Services, ensuring alignment with organizational priorities and compliance requirements.Partner with the Patient Services Training Manager ... leads quality assurance and process improvement initiatives to ensure compliance , consistency, and operational excellence across Insmed's patient services programs.… more
- Cipla (Central Islip, NY)
- …relationships, negotiating favorable contracts, identifying cost-saving opportunities, and maintaining compliance with regulatory and company policies. Success ... performance and resolve any issues or disputes that may arise. Ensure compliance with regulatory requirements, industry standards, and company policies. Ensure… more
- Insmed Incorporated (NJ)
- …Record and cross-functional partners, including ex-US colleaguesWork closely with Legal, Regulatory , Compliance , Medical Affairs, Market Access, and Commercial ... the Role:The Senior Director, Head of US HCP Marketing for our TPIP program in Pulmonary Arterial Hypertension (PAH) will be responsible for shaping and executing… more
- Cipla (Fall River, MA)
- …on time, ensuring accuracy and completeness. Adhering to all cGMPs, compliance / regulatory mandates and quality requirements. Complying with company policies ... and efficient execution of their job duties, while ensuring product compliance to established standards. Essential Duties and Responsibilities : Understanding basics… more
- Cipla (Fall River, MA)
- …and root cause identification and analysis. Capable of handling and participating in compliance and regulatory audits at the local and federal levels. Must ... General: 8:30AM - 5:00PM (may vary based on business needs) Reports To : QA Manager Purpose: The purpose of the Quality Assurance Production Lead (QMS) is to monitor… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Reimbursement), HEOR, Marketing, Commercial Sales, Medical Affairs, and Legal & Compliance . External relationships include Customers as outlined in the Purpose of ... a self-starter who is self led and keeps their manager up to date on progress and ensures no...and downstream impact of the evolving public policy, government, regulatory landscape and other relevant trends Identifies and builds… more
- Cipla (Fall River, MA)
- …on time, ensuring accuracy and completeness. Adhering to all cGMPs, compliance / regulatory mandates and quality requirements. Complying with company policies ... efficient execution of their job duties, while ensuring product compliance to established standards.Essential Duties and Responsibilities: Understanding basics of… more
- Merck & Co. (Rahway, NJ)
- …/ R5-equivalent - About the role We are hiring a Senior Product Manager to lead strategic development of our Integrated Printing and Plastic Manufacturing system ... programs (software, controls, integrations, data/analytics, automation vendors), ensuring disciplined program governance and predictable delivery. Drive release planning, deployment,… more
