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Or a related field - Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology or Biochemistry - with at least 7 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field OR Advanced degree (MS, MBA, Ph. D., PharmD) - minimum of 4 yearsof relevant experience including biological/pharmaceutical research, manufacturing.
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Responsible for approval of medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial outputs for assigned therapeutic areas. Board Certified in therapeutic area and US fellowship training, or MD with 2-4 years’ experience in within the pharmaceutical industry including 2 years in-house Medical Affairs role, or PhD or PharmD with 5 years’ experience within the pharmaceutical industry, including experience in the therapeutic area and 3 years in an in-house Medical Affairs role; MD preferred.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Advanced degree in medical/biosciences (i.e., MD, PhD, PharmD, DPH, EdD, etc.) As necessary and appropriate, support the initial and ongoing medical/scientific area and product specific training and provide key scientific updates to internal stakeholders (e.g. Commercial, Regulatory, Pharmacovigilance, Legal, HEOR, Value Access & Payment.
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BS + 20+ Years relevant experience Global Regulatory affairs, Pharma QMS Development and Management, Clinical Quality, GCP Auditing, Regulatory Inspections experience; MS, MSJ, MBA +18 years relevant experience; PharmD/PHD + 15+ years relevant experience; MD + 9+ years relevant experience.
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Bachelor's degree, in a science, engineering, or a related field - Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology or Biochemistry - with at least 7 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field OR Advanced degree (MS, MBA, Ph. D., PharmD) - minimum of 4 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field.
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Advanced degree in scientific discipline; MD, PhD or PharmD preferred, experience in oncology or inflammatory disease drug development preferred. Works with the regulatory product managers (submissions) and regulatory operations group, for preparation, production and submission of health authority documents using internal & external resources.
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MD or foreign equivalent specializing in neurology or with significant development experience in CNS; PharmD will be considered commensurate with extensive drug development experience with CNS/neurology.
$260,000 - $280,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Provide input to the clinical development plan and lead asset strategy, collaborating closely with functional areas like commercial, regulatory, pharmacovigilance, CMC, and pre-clinical development.
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Knowledge of regulatory guidance regarding marketing/sales promotional materials. Medical/Scientific subject matter expert: Serve as medical leader and subject matter expert providing direction for assigned products including (but not limited to) CRC, scientific communications, publication planning/review, advisory boards, health outcomes plans, MSL activities, speaker programs, investigator-initiated research and CME grant reviews or other internal key business processes.
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Advanced degree in a scientific discipline and 3+ years of industry experience in Cardiology, Rheumatology, or Immunology (MD, PharmD, PhD, DO, NP, PA, MS-CGC) Drives ongoing clinical trial execution at study sites in collaboration with Clinical Research and Development, Clinical Operations, Regulatory Affairs and Program Management including, but not limited to, site identification, evaluation and training, recruitment, and participation at Investigator’s Meetings.
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Bachelor’s or Master's degree in a scientific, life science, or technical discipline required; an advanced degree (PhD, PharmD, MBA) is preferred. In-depth understanding of the drug development process, from nonclinical development to product registration, post-approval requirements or commitments and life-cycle management with a working knowledge of non-clinical development, early- and late-stage clinical development, clinical operations, regulatory affairs, drug safety and pharmacovigilance, drug manufacturing and supply, market access, and commercial functions.
Full-timeExpandApply NowActive JobUpdated 30 days ago - UpvoteDownvoteShare Job
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PhD, PharmD, MD, or equivalent (Education in a discipline related to health services research, epidemiology, biostatistics, or public health is a plus) Demonstrated ability to effectively collaborate with external stakeholders including data partners, patient advocacy groups and disease area/HEOR/RWE experts will be required, as will a strong understanding of EU/US real world data sources and the regulatory/payer requirements for impactful evidence generation.
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Advanced degree preferred (PhD, MD, PharmD, MBA, JD) Broad experience in and across regulatory disciplines (notably global/regional strategy, labeling, clinical, nonclinical, CMC) The role will be a key member of the Global Regulatory Affairs Leadership Team, reporting directly to the VP/Head, Global Regulatory Affairs.
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Bachelors degree in a scientific discipline, Master or PharmD or PhD represent an asset. Additionally, you will be responsible for acting as the global regulatory lead responsible for new development opportunities and executing the maintenance activities for their assigned products for oncology and transplant in General Medicines and Global Health portfolio.
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Provide leadership for the development and writing of regulatory submission documents, including Briefing documents, IND/CTA supporting documents, labelling, and CTD/BLA/MAA documentation for eCTD compliant submissions.
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pharmd regulatory jobs in Jersey City, NJ
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