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Knowledge of the FDA regulatory process and/or experience with an FDA approved medical device. Knowledge in assembly processes like Film lamination, Thermo-Compression Bonding, Surface-mount circuit assembly, wire-bonding, etc.
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Ensure the development and execution of strategic and functional plans and facilitate processes to ensure all Medical Affairs programs and activities are aligned with business strategies and legal and regulatory guidelines.
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Familiarity with Applied Behavior Analysis and competency in the implementation of fundamental procedures as described in Epic’s training protocols and any regulatory or funder requirements (e.g., registered behavior technician training.
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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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Cross-functional clinical processes, including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs. Negotiates cross-functionally, successfully motivates and influences (Clinical Development, Regulatory Affairs, CMC, QA, Pharmacovigilance, etc.
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Assist in the preparation of CMC regulatory submissions, including providing data summaries and trend analysis. Additional responsibilities will include preparation and review of analytical CMC documentation, contribution to authoring and review of analytical sections of regulatory submissions.
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Specific domain knowledge of biotech lab processes, biological systems, and regulatory standards. FL97 is seeking a dedicated and skilled (Sr.) Automation Engineer to join our team. Flagship has created over 100 groundbreaking companies since 2000, including Moderna (NASDAQ: MRNA), Generate Biomedicines, Tessera Therapeutics, Indigo Ag, Inari Agriculture, and Sana Biotechnology.
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The impact you will make:Agios Pharmaceuticals is searching for a dynamic MSL/Sr. MSL (Medical Science Liaison) to join our growing Medical Affairs team. The MSL will conduct scientific exchange with KOLs in supporting Global Medical Affairs goals and objectives.
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Collaborate closely with other departments such as clinical operations, technical operations/CMC, translational research and regulatory affairs to ensure alignment on program objectives. Contribute to the design and oversight of clinical trials, develop study protocols, case report forms, and informed consent documents, ensuring they are conducted in compliance with regulatory standards and ethical guidelines.
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PhD and/or MS degree preferred within Regulatory Affairs, Life Sciences, or Engineering. 6 plus years of experience in Regulatory Affairs, including United States and international medical device and/or IVD/CDx regulations.
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Collaborate with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community. 6+ years' experience in Drug Safety and Pharmacovigilance in pharmaceutical or biotech company, CRO or regulatory agency within Drug Safety/Pharmacovigilance, with both investigational and marketed products.
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Demonstrated track record in leading cross-functional teams and work streams (e.g., translational medicine, biostatistics, regulatory, pre-clinical pharmacology, clinical and immunogenicity assay development.
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Knowledge of pharmaceutical industry and Project management experience within Medical Affairs, Clinical Research, Regulatory, CMC, Marketing or other drug development related function. Knowledge of regulatory and compliance guidelines governing medical affairs.
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Serves as an independent Medical Monitor for clinical trials from Phase 1 through Proof-of-Concept byArticulating clinical development strategyAnalyzing, interpreting, and acting on clinical trial data to support developmentServing as principal functional author for Regulatory submission, study reports, and publications.
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Coordinates and acts as liaison on behalf of the architecture department and MDE program with other GSD departments such as the Office of Communications, Finance, Frances Loeb Library, Student Affairs, Development and Alumni Relations, etc.
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regulatory affairs jobs Title: sr regulatory affairs in Lexington, MA
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