- Legend Biotech USA, Inc. (Raritan, NJ)
- …across the validation lifecycleAlign global documentation strategyProvide input and review for validation documents including master plans, PPQ and comparability ... protocols and reportsServe as reviewer /author of a variety CMC sections or regulatory submissions,...and supported every step of the way. Highlights include medical , dental, and vision insurance as well as a… more
- Commonwealth Care Alliance (Boston, MA)
- …Reviewer is responsible for day-to-day timely clinical and service authorization review for medical necessity and decision-making. The Nurse Utilization ... clinical teams on service planning as needed + Works closely with CCA Clinicians, Medical Staff and Peer Reviewers to facilitate escalated reviews in accordance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Gains strategic and planning alignment across regions and functions and supports review of Local Country/Regional Medical Affairs activities when applicable. ... studies (IIS) and may serve as deputy compound lead in Global IIS Review Committee meetings.- Leads selecting medical education and other scientific exchange… more
- Insmed Incorporated (NJ)
- …writing team on document planning, processes, content, and provides peer review as needed.Provides inputs for medical writing processes, standards, and ... of science, we're in. Are you?About the Role:The Principal Medical Writer is a REMOTE position, responsible for the...REMOTE position, responsible for the development and management of medical writing deliverables, including but are not limited to… more
- Eisai, Inc (Nutley, NJ)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... your profile, we want to hear from you. The Medical Science Liaison (MSL) is a field-facing representative of... Affairs and development groups.Establish, foster, cultivate and maintain peer relationships with KOLs in the therapeutic areas in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in-process, or final product samples submitted to the QC laboratories.Perform peer review /approval of laboratory data.Utilize electronic systems (LIMS) for ... execution and documentation of testing.Create, review and approve relevant QC documents, SOP's and WI's.Perform...and supported every step of the way. Highlights include medical , dental, and vision insurance as well as a… more
- The Joint Commission (Oakbrook Terrace, IL)
- …Field Representatives, with minimal direction or supervision, survey and/or review health care organizations throughout the United States. Field Representatives ... **Responsibilities** Position Accountabilities: + Ability to analyze and synthesize survey/ review findings to provide conclusions, recommendations and educational opportunities.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …provide guidance and determine immediate path forward for manufacturing quality issues. Review of all documentation, in accordance with Good Documentation Practices ... (GDP). Review , revise, or draft Standard Operating Procedures (SOPs)Support processes...and supported every step of the way. Highlights include medical , dental, and vision insurance as well as a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …oversight of technical, qualification, and validation activities including data or document review and approval as needed. This role will be responsible for ... within the siteReview and approve qualification/validation documentation (specifications, protocols, reports). Review and approve periodic review documentation for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …through completion.Schedule and participate in the site change control review board meetings.Manage change control metrics reporting.Collaborate with functional ... manner consistent with the safety policies, quality systems and cGMP requirements. Review change controls, SOPs, and other documentation.Require minimal direction to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …generation strategies and activities as part of the USOMA Plan. Provides medical review of expanded access programs (EAP) and, investigator-initiated studies ... of a US IIS Review Committee, for assigned compound. Collaborates with Global Medical Affairs and across USOMA functions to develop, review , and align on key… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Compliance initiatives, such as inspection readiness, metrics implementation and review , overall regulatory compliance and implementation programs, and others as ... and gathering of quality metrics for Legend's Quality Management Review (QMR).Support management of the Quality Management Review...and supported every step of the way. Highlights include medical , dental, and vision insurance as well as a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for end-to-end manufacturing issues.Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints.Perform ... they feel valued and supported every step of the way. Highlights include medical , dental, and vision insurance as well as a 401(k)-retirement plan with company… more
- Merck & Co. (Boston, MA)
- …TMed at governance for the Neuroscience portfolio (discovery therapeutic area review , early and late-stage clinical governance), and fully supportive of ... the deep subject matter expertise in Translational Neuroscience MedicineNeuroscience Discovery Review core memberRepresent TMed at core governance (early and late… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with many stakeholders.Support other quality systems activities, as needed.Support drafting, review and approval of standard operating procedures and any other ... they feel valued and supported every step of the way. Highlights include medical , dental, and vision insurance as well as a 401(k)-retirement plan with company… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …forms, etc. are printed and available for productionOversee batch records review and completeness of all associated documentation ensuring compliance with written ... and procedures as required for batch releasePerform First Quality review for executed batch records dailyPerform other assigned duties...and supported every step of the way. Highlights include medical , dental, and vision insurance as well as a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …resolution for manufacturing issues.Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints. ... they feel valued and supported every step of the way. Highlights include medical , dental, and vision insurance as well as a 401(k)-retirement plan with company… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …integrityExecutes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentationParticipates in authoring ... they feel valued and supported every step of the way. Highlights include medical , dental, and vision insurance as well as a 401(k)-retirement plan with company… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …system (LIMS)Prepare documents and coordinate Sample shipment (internal and external shipments) Review logbooks and/ or LIMs to align physical quantities of samples ... or higherA minimum of two (2) years related experience in medical device, biopharmaceutical, or pharmaceutical industryA degree in Biology, Biochemistry,… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …and clinical functions.Manage non-GLP and GLP-compliant studies conducted at CROs; review protocols, monitor studies, and interpret data.Serve as the primary ... they feel valued and supported every step of the way. Highlights include medical , dental, and vision insurance as well as a 401(k)-retirement plan with company… more
