| Job alert | Jobs 31 - 40 of 463 |
Senior Director of Medical Writing
Larimar Therapeutics
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Bala Cynwyd, PA, 19004
... Proven track record of successful submissions to regulatory authorities (e.g., FDA, EMA). Strong leadership skills with experience managing internal staff and external vendors. Excellent communication, organizational, and project management skills. ... - Jun 01
Senior Scientist
Insight Global
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Lansdale, PA, 19446
... Experience with Quality by Design (QbD) and Lean Six Sigma principles Experience supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA) Experience with on-the-floor Good ... - Jun 02
Senior Validation Engineer (Medical Device)
LifeLens Technologies Inc.
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Warminster, PA, 18974
... Knowledge of FDA medical device regulations and international standards for medical devices. Certified Quality Engineer (CQE) certification is a plus. Benefits: Health Insurance Dental & Vision Insurance Stock Options Paid Time Off Flextime - May 21
Project Manager, Central Laboratory Services
Frontage Laboratories
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Exton, PA, 19341
... related documentation as needed and per client request Support Management and BD team for new business opportunities Maintain a general working knowledge of phase I-IV clinical trials, FDA regulations/ICH guidelines and other pertinent regulations. ... - Jun 03
Mammography Technologist - Per Diem - Paoli, PA BONUS
Onsite Women's Health
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Paoli, PA
... Maintains all QA documents necessary to exceed Annual FDA Inspection requirements. Is responsible for obtaining and maintaining ACR accreditation. Exceptional compensation for the right candidate! Experience: Mammography: 2 years (Required) License: ... - Jun 01
Senior Scientist (Upstream)
Insight Global
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Lansdale, PA, 19446
... Experience supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA) Job Description The Vaccine Process Development and Commercialization (VPDC) group within our Company's ... - Jun 02
Compounder (WKND)
Accupac
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Harleysville, PA, 19451
... The Manufacturing operation is performed in a manner that complies with Accupac’s SOP and the FDA’s Good Manufacturing Practices Regulations. Essential Functions of the Job: Compounder level and compensation will be determined by successful ... - May 14
Executive Director, Biostatistics
Madrigal Pharmaceuticals
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Conshohocken, PA, 19428
... in Statistics or Biostatistics with 10+ years of experience in Pharma or Biotech companies * Proven experience in supporting NDA regulatory submissions, and meeting with health authorities (e.g, FDA, EMA, PMDA) * Demonstrated expertise in advanced ... - May 30
Senior Director Regulatory Affairs CMC
VenatoRx Pharmaceuticals, Inc.
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Malvern, PA, 19355
... Knowledge and practical understanding of ICH Guidelines regarding GMP/GCP and CTD/eCTD, and US FDA CDER requirements for the drug approval process. Previous participation in preparing Regulatory submissions (e.g., IND, CTA, NDA, etc.) Solid ... - Jun 03
Quality Control Analyst
NEUROVUE
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Philadelphia, PA
... Maintain compliance with all legal regulations including GMP/ FDA/ISO standards. Essential Functions and Responsibilities Perform daily GMP Quality Control laboratory testing activities with minimal to no errors while ensuring testing is completed ... - May 31