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Experience with laws, regulations and industry guidance that affect the pharmaceutical industry including, but not limited to, FCPA, SFO, OIG, IFPMA, PhRMA & EFPIA guidelines, healthcare standard operating procedures, regulations governing drug and medical devices, anti-bribery laws, and state price reporting statute.
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Experience in peptide method development, characterization, and analytical control strategy, especially having mass spectroscopy (MS) experience. Provide analytical data to support drug substance and drug product development, including purity analysis, chiral purity and structure elucidation using mass spectrometry.
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May be a team leader and contributes to the leadership of RCMC.You will be responsible for:Lead the development and implementation of global CMC regulatory strategy supporting CGT products.
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The Nucleic Acid Vaccines Center of Excellence (NAV CoE), a global team within the GSK’s Drugs Substance (DS) Vaccine’s Technical Research and Development organization, has as a mission to develop the next generation RNA Drug Substance vaccine platforms for rapid development of new vaccine candidates.
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The applicant is expected to develop highly effective collaborations with relevant stakeholders including those in Patient Health & Impact, the Patient-Centered Outcomes Assessment Group, Statistics, Clinical Pharmacology, Clinical Development, Medical Affairs, Epidemiology, Programming, and other groups contributing to HEOR analysis and strategy.
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Moderna Infectious Disease Development is seeking a motivated and energetic Program Leader with a broad scientific skill base and deep expertise in infectious disease research and development to lead the Cytomegalovirus Vaccine Program Team. The Program Leader will lead a cross-functional team to develop and align stakeholders on the development and regulatory strategy and drive progression of the vaccine candidate through late-phase development, filing, approval, and lifecycle management.
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Working with an experienced Program Manager and a cross-functional team, the PTL shapes the Program strategy, goals, priorities, and plans, bringing both a 'future-orientation' toward the ultimate goal of broad, global commercial access for patients in need, and a "pragmatic-orientation" to chart the path, mitigate risks, cultivate options, and lead through complex drug development decisions.
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Participation in NDA/MAA/Submission experienceTrack record and demonstrated ability to lead and manage both science and business aspects of drug development. The MDMP interacts and partners with marketed products R&D function leads (regulatory affairs, pharmacovigilance, global development operations and project management) to set R&D strategy and prioritize R&D functional support for assigned MP portfolio.
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Independently Plan, perform, and provide oversight for appropriate analyses of preclinical-clinical translation and clinical exposure-response relationships, to guide clinical dose regimen selection and support overall drug development strategy.
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The Associate Director of Regulatory Affairs Strategy will be responsible for developing regulatory strategies to support clinical development plans, working cross-functionally across the organization.
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Trusted by leading health systems, payers, biopharma companies and patients alike, Biofourmis' connected platform improves patient outcomes, prevents hospital readmissions, accelerates drug development, and closes critical gaps in care-ultimately making science smarter, healthcare simpler, and patients healthier.
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Solid working knowledge of strategic planning, execution of strategy, business development and sales Demonstrated solid leadership qualities and organizational skills Flexible to work between the hours of 8AM ET and 5PM ET including weekends and holidays with the possibility to flex up or down hours depending on business needs.
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Our client offers preclinical services for drug discovery, focused on the use of nonhuman primates to determine pharmacokinetics, pharmacology and toxicology of small molecules and biologics. Job Title: Business Development Director.
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Assist in the development of CMC regulatory submissions for domestic and international markets. Knowledge of domestic/international drug, biologics, tissue and combination product regulations/standards/guidance’s.
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As part of the Global Oncology Products and Pipeline Strategy team, you will report to Vice President, Global Oncology Products & Pipeline Strategy and work with Global Business Development (GBD), Center for External Innovation (CEI), New Products Planning (NPP), Oncology Therapeutic Area Unit (OTAU), and Oncology Drug Discovery Unit (ODDU) to evolve and drive Takeda Oncology BD goals and strategy.
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drug development strategy jobs in Waltham, MA
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