with customers or patrons. Prepare documentation for contracts, transactions, or regulatory compliance. Compile data...
, and performance. Partner with internal subject matter experts (commercial, medical affairs, clinical development, legal, regulatory...
Microsoft Office skills Strong attention to detail Expertise in clinical development process (Phase 1-3), global regulatory...
, including ISO or industry-specific standards. Prepare and maintain documentation, reports, and records for audits, regulatory...., ISO 9001), regulatory requirements, and industry standards, with the ability to maintain compliance and certification...
to mitigate risk and meet regulatory obligations. Key Responsibilities Monitoring the team’s daily incoming... information for regulatory request inquiries. Core Strengths and Skills Desire to learn new concepts and technologies...
collaboratively with stakeholders in Medical Affairs, Regulatory, PV to determine dates of program data deliverables Provide expert... knowledge of regulatory guidelines (FDA/CFR, ICH/GCP), CDISC standards and eCTD submission requirements Excellent communication...
committee meeting to support key decision-making, drive conclusions and develop next steps Work closely with Regulatory Affairs... of aggregate safety reports such as PSUR, DSUR, PADER, and other periodic reports Contribute to preparation of relevant regulatory...
remit and scope of this role. You will provide consistent communication of safety topics across all regulatory safety.... PBRERs, PSURs, or DSURs) and renewal documentation submitted to regulatory agencies and the patient safety contribution...
and practices, and how other enterprises are employing them. Applying I&O capabilities to achieve regulatory or statutory...
/manufacturing and regulatory approval of Deciphera anticancer drug products as both a subject matter expert and leader of cross... that are critical to moving Deciphera's clinical program programs forward. The role provides for technical and regulatory exposure...
across all levels in research, development, clinical pharmacology, new product planning, biostatistics, project management, regulatory... protocols, study reports, statistical analysis plans, regulatory documents, and external publications Contribute to strategic...
business partnering activities to the Clinical, US Medical, and Regulatory teams. The Senior Analyst, Financial Planning...-end close activities by working in close collaboration with the Clinical, US Medical, Regulatory, and accounting teams...
-related areas, including protocol development and study conduct Work cross functionally with Regulatory Affairs and Quality... Assurance functions to maintain current knowledge of regulatory safety reporting guidelines and implementing relevant guidelines...
with internal teams, including Clinical Development, Regulatory Affairs, Biostatistics, Translational Medicine and Program..., timelines and quality standards Ensure compliance with regulatory requirements, ICH-GCP requirements, and company SOPs...
and regulatory compliance. Responsibilities Staff Pharmacist Responsibilities: Applies the principles of pharmaceutical care...
all phases of drug development and regulatory interactions, in a company that follows the science and turns ideas into life...
integration and compliance with regulatory requirements, and successful implementation at the receiving site. Vendors Database... with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), or other regulatory standards like Food and Drug...
-Clinical safety-relevant documents to support regulatory filings including initial INDs, IND annual updates, IBs, DSURs.... Initial BLAs/review queries, as well as briefing books for US FDA, EMA, and other international regulatory meetings...
and compensation guidance and execution Ensure Compliance with Company policies, as well as State, Federal and other regulatory... documents. Ability to respond to common inquiries from patients, team members, regulatory agencies, vendors, or other members...
to ensure compliance with company standards (SOPs), internal specifications, GxP requirements, and regulatory guidelines... are made as required by regulatory and compliance offices (both governmental and internal) to address significant deviations...