Microsoft Office skills Strong attention to detail Expertise in clinical development process (Phase 1-3), global regulatory... at improving the operational performance and quality of all clinical trials sponsored by Deciphera Pharmaceuticals. Lead the...
Job Description We are seeking a Director, Drug Product Development to lead and manage formulation development.../manufacturing and regulatory approval of Deciphera anticancer drug products as both a subject matter expert and leader of cross...
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...
all phases of drug development and regulatory interactions, in a company that follows the science and turns ideas into life... changing medicines? Then AstraZeneca might be the one for you! AstraZeneca is a global, science-led, patient-focused...
a team is a plus Expertise in global regulatory and compliance requirements for clinical research, including but not limited... who knows how to manage a team internally, at our clinical sites, and with our vendors. Lead and oversee the strategic...
responses, literature surveillance, and safety analyses for regulatory submissions (NDA, MAA, etc.). For investigational... communication. The position will report to the Associate Director, Risk Management Lead and will be located in the Waltham...
: Site lead for all Waltham, MA Quality related responsibilities, leading and coordinating Quality Assurance activities... to ensure compliance with company standards (SOPs), internal specifications, GxP requirements, and regulatory guidelines...
details are available at the link below: About Medtronic We lead global healthcare technology and boldly attack the most challenging health...-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead...
Introduction to role The Associate Director, Apheresis Patient Operations, will lead all aspects of the onboarding... the cell journey and ensuring compliance with Chain of Identity and Chain of Custody protocols. You will lead a team...
as a regulatory or medical writer, with at least 2 years of global clinical trials transparency/disclosure process and strategy... for creating and managing documents for global clinical trial disclosure and data transparency activities per applicable laws...
, etc) and lead the development of effective, operational control strategies. Support regulatory strategy and activities, including... authoring and reviewing relevant sections of global regulatory filings, as appropriate Additional Responsibilities Leverage...
&D, Global CMC Development is a key enabler of Sanofi’s growth aspiration through its mission to develop manufacturing processes..., formulations, and analytical methods for new clinical drugs. Global BioAnalytics provide strong, science-based and quality-driven...
Job Title: GMU CMC Operations Lead Location: Waltham, MA Duration: 12+ Months Pay rate: $48.25/hr Department.... This encompasses drug substance (DS), drug product (DP) and analytical development, DS/DP clinical manufacturing, and support of global...
will also take part in the potential regulatory filing to serve as the lead biostatistician for integrated data analysis. The ideal... that could be at the stage of clinical development, regulatory filing, or commercialization. Reporting to the VP, Head of Biometrics...
on matters relating to the assigned development program including operational, regulatory and drug safety. Previous experience... working on and monitoring clinical trials is required, experience working on regulatory submission documents preferred...
and take a lead in different People-related projects. Qualifications Proficiency in reading and writing in Spanish and Portuguese... and ability to follow procedures and identify process efficiencies. Ability to maintain confidentiality and adhere to regulatory...
Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High... and integrations to ensure product quality and compliance with SOPs and regulatory standards. The responsibility includes...
Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High... and integrations to ensure product quality and compliance with SOPs and regulatory standards. The responsibility includes...
, and others. What you will do: Lead the composition and submission of ESG related reports, regulatory filings and disclosures, ensuring alignment..., and external financial reporting. If you have a passion for developing and deploying an enterprise-wide regulatory reporting...
). Experience interacting with global regulatory agencies, including successful NDA or BLA submissions and approvals, is highly... Director will participate in internal strategy regarding future therapeutic priorities and interact externally with key global...