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Worked on drug trials that use a biomarker to select patients into the trial, include but not limited to, understand clinical trial assay (CTA) requirements with diagnostic partners, sample testing/shipping regulations in different countries, and CDx development requirements.
$55 an hourExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value of our pharmaceutical products across therapeutic areas.
ExpandApply NowActive JobUpdated 25 days ago - UpvoteDownvoteShare Job
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Understanding of strategic and tactical role for the drug development process." Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input.
$55 an hourExpandApply NowActive JobUpdated 29 days ago - UpvoteDownvoteShare Job
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Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents) Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations Experience in drug development processes and post-approval requirements Experience in developing CMC regulatory strategy Experience in project management Have a solution-oriented approach to problem solving Ability to plan/prioritize work of group members and guide/develop others.
ExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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The Principal Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines to enable development of biologics active pharmaceutical ingredients (APIs.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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7 or More Years MS, RN, or PharmD preferred, or total pharmaceutical industry experience in one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development preferred.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Board certified Dermatologist with 6 years (MD or equivalent) or equivalent experience, 10 years (PhD or PharmD) or equivalent experience of involvement in clinical research or drug development in an industry environment spanning clinical activities in Phases I through III/IV, including submission dossiers.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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And act as the HEOR project/group champion and spokesperson High goal-orientation with the ability to see solutions rather than problems as projects encounter the inevitable ups and downs associated with new drug development or on-market product support.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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They will be responsible for supporting projects surrounding a specialized drug delivery method and the strategy to support clinical studies/commercialization. Lead the implementation and/or ensures effective execution of the Device Development Strategy, Design Control and Risk Management activities for the assigned projects.
$77 an hourFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Experience with drug development, commercialization, healthcare, clinical trial management a plus. We help clients with new skilling, talent strategy, leadership development, employee experience, transformational change management and beyond.
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Possesses proficient scientific expertise to propose, design, and execute clinical research and development studies for early and/or late stage assets; able to conceive and communicate strategy proposals well-grounded in supporting literature.
Full-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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The role will partner across key strategic/operational functions across the matrix and report to the Director of Strategy & Operations, Hematology & Oncology. 3-5+ years of experience in pharmaceutical research, development, or commercialization.
$59.73 an hourExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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This role will be a strategic and operational portfolio partner for the Hematology & Oncology medical leads in delivering key portfolio related priorities. Examples: medical planning, annual portfolio budgeting, and project support for critical clinical trials.
$61 an hourExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Partner with Medical Team Lead/core team to facilitate medical matrix team meetings, ensure the agenda is focused on key deliverables, risk management, issue identification and resolution. Project management foundation and relevant experience on matrix management, budget management, metrics and leadership communication.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Expert understanding of drug development process and understanding of scientific content and complexities related to a project in Oncology. Expert understanding of policy, laws, regulations, and guidelines as they apply to U.S. FDA for drug development and approval.
ExpandApply NowActive JobUpdated 2 months ago
drug development strategy jobs in Summit, NJ
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