- Dana-Farber Cancer Institute (Brookline, MA)
- …environment. + Bachelor's degree required + Minimum of 5 years of experience in clinical research , regulatory compliance, or clinical trial operations, ... sponsor requirements. The Manager collaborates with investigators, research teams, and regulatory staff to maintain the integrity of clinical trial data and… more
- Bausch + Lomb (Boston, MA)
- …mentor individuals on subject matter expertise + Provide guidance and direction regarding regulatory strategy to project teams + Participate in assigned due ... US and/or Canada + Formulate, lead, and drive integrated regulatory strategies across CMC and clinical /non- clinical...external regulatory stakeholders and shape the external regulatory environment. + Advanced Project Management /… more
- Pfizer (Cambridge, MA)
- …with key internal and external partners, such as project leaders, research units, biostatistics, regulatory affairs, clinical pharmacology, human ... clinical teams with Pfizer development operations and the project team, to meet enrollment and study delivery timelines....among teams and therapeutic areas. + Coordinate with other clinical research activities within Oncology Research… more
- ConvaTec (Lexington, MA)
- …+ Working closely with Clinical Study Managers (CSMs) and Clinical Research Associates (CRAs), manage all operational aspects from start-up ... budget forecasting activities. + Support the selection, oversight, and management of Clinical Research Organizations (CROs) and other vendors for clinical… more
- Bristol Myers Squibb (Cambridge, MA)
- …the Global Research organization in BMS and leads late stage clinical , pharmacological and translational research and development activities for the pipeline ... and supports late stage portfolio for regulatory , translational development and life cycle management. Translational Development drives strategy across core… more
- Parexel (Boston, MA)
- …business management is desirable. + Minimum of 6 years of relevant experience in clinical research including at least 2 years of direct experience with ... Maintain current regulatory inspection knowledge as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies worldwide, especially those… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …highly innovative treatments to patients. These scientists (from quantitative clinical pharmacology, statistics, programming, outcomes research and epidemiology, ... simulation approaches (eg, QSP, MBMA) to inform internal decisions and external regulatory interactions. + Represents Clinical Pharmacology in meetings with… more
- Pfizer (Cambridge, MA)
- …or supports other critical documents, eg, protocol amendments, investigator brochure, and regulatory documents. + Collaborate with Clinical Operations to ensure ... prepare presentations regarding strategy and/or data, and may assist with authoring clinical sections of regulatory documents (IB, Annual Reports, IND sections,… more
- AbbVie (Cambridge, MA)
- …Completion of a subspecialty fellowship is desirable. + Ability to run a clinical research study with appropriate supervision. + Strong desire to collaborate ... Job Description With supervision, oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …simulation approaches (eg, QSP, MBMA) to inform internal decisions and external regulatory interactions. + Represents Clinical Pharmacology in meetings with ... global or regional regulatory agencies and is responsible for clinical pharmacology summary documents for regulatory submissions. + Oversees and/or… more