- Pfizer (Cambridge, MA)
- ROLE SUMMARY The Clinical Trial Transparency and Disclosure Manager (Senior Manager) is an integral member of the Medical Writing department. The role is ... requirements. These requirements include, but are not limited to, EMA Policy 0070, EU Clinical Trial Regulation, Health Canada Public Release of Clinical … more
- Pfizer (Cambridge, MA)
- …strategies with global strategies + May provide indication-specific input for efficient clinical trial development and response to regulatory authorities + May ... with the Safety Risk Lead, ensures patient safety during clinical trial conduct plus consistent, and focused...health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations… more
- Pfizer (Cambridge, MA)
- …cross-functional PCT team, internal stakeholders, and academic partners to create pragmatic clinical trial protocols. + Experienced in leadership of matrix teams ... their work. **PREFERRED QUALIFICATIONS** + Experience designing and executing a randomized pragmatic clinical trial . + At least 5 years' experience in … more
- Pfizer (Cambridge, MA)
- …cultivates collegial relationships with key clinical experts, academic entities, and clinical trial sites, and uses these relationships to help establish ... for. + Serves as a Medically Qualified Individual (MQI) at Pfizer, reviewing clinical trial data for safety signal identification and tracking. + Provides… more
- Pfizer (Cambridge, MA)
- …with external academic and industrial partners Guide implementation of imaging in clinical trials: + Advise on appropriate imaging biomarkers and endpoints + Provide ... input on study protocols and imaging-specific trial documents + Assist in selection of imaging core...links with academic teams worldwide + Educate research and clinical teams on the values and limitations of imaging… more
- Pfizer (Cambridge, MA)
- …and other functional lines for the successful implementation and execution of the clinical trial (s) within the assigned program. + Responsible for scientific ... oversight, data integrity and quality of the clinical trial (s). + Represents the study team...health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations… more
- Pfizer (Cambridge, MA)
- …communication of statistical analyses, data presentations, and scientific reports, including clinical trial results, exploratory and meta-analysis results **,** ... + A minimum of 4 years' experience in the clinical trial setting (preferably in oncology of...health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations… more
- Pfizer (Cambridge, MA)
- …analyses of Real World Data. + Develop and advocate for Phase IV lifecycle clinical trial strategies and concepts to support regional medical business needs + ... program that include several assets in Lung Cancer** providing strategic leadership for clinical research and launch readiness. S/he will also be responsible for the… more
- Pfizer (Cambridge, MA)
- …pipeline, key milestones and resources needs + Oversees and coordinates any needs for clinical trial support and other needs for Anti-Infectives in the US ... outcomes and create business impact. + MD required and 5+ years of clinical experience + Significant industry and research experience, including a minimum of 5… more
- Pfizer (Cambridge, MA)
- …change, external environment, project scope and direction **PREFERRED QUALIFICATIONS** + Clinical trial exposure/experience preferred + Prior Experience in ... in Medical Affairs organization is essential and experience in other medical/ clinical functions desirable. + Prior experience in Project Management, Business… more