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Expert in GCDMP, CDISC standards, regulatory compliance (21 CFR Part 11, GDPR), and proficient in MedDRA and WHO-Drug coding, ensuring adherence to ICH GCP and industry standards. Bachelor’s Degree in Life sciences, including a min of 8 years in CDM, leading critical oncology or immunology projects from startup to database lock, adept at handling data for regulatory submissions, and proficient in Veeva EDC system management with a solid scientific educational background.
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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). Series 07 - FINRA, Series 24 - FINRA.
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Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology. The impact you will make:Agios Pharmaceuticals is searching for a dynamic Senior Manager, Medical Writing to join our growing Regulatory Affairs & Medical Writing team.
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Familiarity with regulatory requirements and standards, such as OSHA, NFPA, and IEC. Certification in PLC programming or related control systems. Strong knowledge of PLC systems from major manufacturers, e.g., Siemens, Allen-Bradley, Schneider Electric.
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You will achieve the above by relying on internal resources throughout the organization, in particular in Drug Discovery and Development and by leveraging external relationships and ensure that clinical imaging activities adhere to regulatory and industry standards and ensures the regulatory acceptance of new imaging biomarker programs.
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A minimum of 8-10 years of pharma/biotech industry experience in drug development including experience in clinical drug development, commercialization, and regulatory knowledge. Knowledge of GMP regulations, ICH guidelines; as well as CMC content of regulatory submissions.
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May be responsible for the following activities: recruiting and evaluating patients for studies; performing cognitive testing, recruiting participants for studies, scheduling appointments, assuring completion of visits and accurate data collection and entry, data processing, assisting/managing IRB submissions, interacting with regulatory personnel, administering transcranial magnetic stimulation, and maintaining and updating data generated by the study.
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This individual will be responsible for supporting the GDS Director in overseeing all aspects of safety vendor management including case workflow, regulatory submissions and compliance management across all Cerevel clinical study protocols.
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Proven ability to:Lead technical teams and deliver high-quality results within established timelines Utilize technology supporting pharmacovigilance Integrate concepts and guidelines from FDA, EMA, PMDA and other regulatory agencies, public health agencies and nongovernmental organizations, and clinical practice groups Investigate new safety issues Communicate medical product benefits and risks to regulatory and public health authorities as well as the public.
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Author and review SOPs, technical reports, and assist in the preparation of CMC regulatory submissions. Experience with qPCR, DNA and RNA extraction, ELISA, western blotting, UV spectrophotometry, DLS, MALS, mass spectrometry, and compendial testing will be a plus.
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You are results-oriented and have comprehensive knowledge of the drug development process and have a demonstrated record of successful regulatory submissions (IND, CTA, NDA/MAA, etc.) You will be the primary contact to interface with FDA and will lead cross-functional teams to deliver domestic and international regulatory submissions including IND, CTA, NDA and MAA submissions.
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Collect and audit data for compliance reporting/testing across the benefit function including but not limited to; 5500 Health & Welfare & 401k, 401k Audit, SAR Distribution & True-up, Non Discrimination Testing – HSA/FSA & 401k, HIRD & CMS Disclosure, Medicare Part D Disclosure and ACA Reporting Ensure compliance with all regulatory filings and reporting requirements.
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Manages relationships with regulatory agencies regarding operational risk management including, but not limited to, the Federal Reserve, FDIC, PRA, FCA, ECB, etc. Collaborate day-to-day on Operational and Technology Risk governance practices across ERM functions as well as Legal, Compliance, Regulatory and Industry Affairs and Corporate Audit to further enhance the connectivity of ERM processes.
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Experience with dealing with Import/export/Interstate permits/licenses and associated regulatory agencies (US at a minimum – US Customs, FDA, USDA, USFWS, CDC, EPA, DEA, etc. Experience with dealing with Import/export/Interstate permits/licenses and associated regulatory agencies (US at a minimum – US Customs, FDA, USDA, USFWS, CDC, EPA, DEA, etc.
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Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF) Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF.
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regulatory job Title: principal consultant Company: Parexel in Cambridge, MA
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