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This position will also contribute to the MLSC's government relations activity and work closely with our Senior Director of Marketing and Corporate Relations and Senior Digital Marketing and Communications Associate on developing and executing e-communications, social media campaigns, and uncovering new ways to enhance our digital presence, storytelling prowess, and reporting techniques.
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Reporting to the VP, Clinical Operations & Medical Writing the Sr. Director will ensure that clinical stage programs achieve program objectives within established timelines, budget and quality standards.
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What Youll Do: Reporting to the VP, Regulatory Affairs, the Executive Director, Medical Writing will establish the function and oversee internal and external medical writing resourcing to support authoring needs.
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Support writing and review applicable sections of CMC regulatory filings. This position is anon-site position at our Waltham, MA office with up to 25% domestic and international travel required, and will report to the Senior Director, Pharmaceutical Engineering.
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EVALUATION: Performance of this position will be evaluated annually in writing by the Director of School Nutrition. REPORTS TO: Director of School Nutrition. Report grievances to the Food Service Director.
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Works with the VP GNAT ED, and early clinical development functions including Non-Clinical Research, Bioanalytics, Clinical Operations, Medical Writing, Program Management, CMC and Regulatory Affairs.
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Responsible for the oversight of clinical study execution in close collaboration with Clinical Operations lead, internal and external stakeholders (data management, biostatistics, programming, drug safety and PV, medical imaging, medical writing, research and discovery.
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Leads CLINICAL PHARMACOLOGY regulatory documents writing, submission and response to Regulatory agency comments. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio.
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In this role, she/he will lead the execution of the clinical studies in conformance with Good Clinical Practices (GCP), International Conference of Harmonization (ICH) Guidelines and Kiniksa SOPs. This role will work closely and collaboratively with Program Management, Clinical, Medical Writing, Biostatistics, CMC, Drug Safety and Regulatory staff as well as Clinical Research Organizations, to ensure the timely execution of studies within budget.
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Such work experience included acquiring data and providing information to producers, farm loan borrowers and farming operations; writing summary reports; assisting staff with policy guidance; arranging and scheduling activities of subordinates to complete technical/clerical review.
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As Product Marketing Director you will be responsible for driving the success of L2L products in market through a mix of market and competitor research, product messaging and storytelling, and go-to-market planning.
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The Senior/Executive Director, Medical Writing (MW) will be responsible for establishing the function and play a 'hands-on' role in shaping the communication, the development, and the delivery of clinical and scientific data to regulatory agencies, healthcare professionals, and other stakeholders.
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Partner within regulatory, medical writing, project management and across functions to plan, develop, and manage marketing applications from a regulatory operations perspective. The Senior Director, Regulatory Information Management role is accountable for developing and implementing the strategy and processes for regulatory information management as well as global marketing application readiness and planning.
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We're seeking a talented Senior Clinical Trial Manager (SCTM) or Associate Director (AD) to join our team and play a pivotal role in managing clinical trials for a novel precision kinase inhibitor.
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In coordination with the associate director, draft produce high-level development & stewardship communications content, including acknowledgments, narrative and financial reports, major donor correspondence, proposals, newsletters, videos, campaign communications, email blasts, web content, event-related remarks, pre- and post-event messaging, including drafting material for executive leadership, senior managers, and key volunteers.
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writing director jobs in Concord, MA
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