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Medical Director for High Profile Pharmaceutical company Looking for an M.D. to work with the Head of Medical Affairs with Immunology / Oncology launch! Contract (or contract to perm). VP would consider an individual from academia - provided they had a strong background in immunology/oncology/hematology or a seasoned Pharmaceutical Professional


AD, Rare Disease Business Development Reporting to the Head of Business and Corporate Development, this role will serve as a key member of the Corporate and Business Development team, working closely with cross functional partners and the executive management team to advance initiatives that support the corporate vision and goals. These initiatives include buy-side activities, sell-side activities, and corporate strategy projects. The Senior Manager will play a leading role for the strategic....

- San Francisco, CA

Acts as the CEO of assigned early development projects for the assigned division, which may involve managing direct reports. Acts as an expert product developer with proven entrepreneurial ability and mind-set; understanding the scientific, technical, clinical and commercial context for programs from clinical candidate selection (CCS) to readiness for phase III and enabling a seamless transition into later stages of development. Acts as a program champion and is objective and strategic about....

- Any US State

The role of the Principal Writer, Medical Writing, is to prepare high quality clinical documents and to oversee medical writing responsibilities for multiple programs within an assigned therapeutic area (TA) of Global Branded R&D (including, as appropriate, drugs, biologics, and devices). In this position, the incumbent manages the planning and preparation of high-quality clinical documents (eg, clinical study reports, briefing books, clinical protocols, integrated summaries) and ensures....


Clinical/Sr. Clinical Program Coordinator (Contract) The Clinical/Sr. Clinical Program Coordinator is responsible for supporting the clinical development operations team across multiple clinical studies and programs, as well as clinical development operations department-wide activities and initiatives. Responsibilities: Study team and department support QC study documentsCoordinate sponsor team review and finalization of key study documentsSupport study team during key deliverable....


Global Pharmaceutical company in Madison, NJ is hiring an Executive Director for Clinical Data Management Executive Director, Clinical Data Management is responsible for providing clear vision and strategic direction for Clinical Data Management practices at Company. Planning, directing, and coordinating Clinical Data Management activities including (but not limited to) database specifications development, data management plan creation, data review and reconciliation. The Executive Director,....


The Manager, Medical Information will assist in the operational oversight of medical information within the Medical Affairs function under the guidance of the Lead of Medical Information. The manager will be responsible for providing and supporting the provision of accurate, scientifically balanced and timely responses to inquiries received from health care professionals, consumers and other customers. The manager will monitor the scientific literature and communicate new data to relevant....

- Norwood, MA

Manufacturing Associate (five needs) 1st and 2nd Shifts available 6 month contract, and renewable up to 4 years Company is seeking a cGMP Manufacturing Associate for mRNA Manufacturing of Personalized Cancer Vaccines. This position will eventually transition from Cambridge, MA to our new GMP Manufacturing site in Norwood, MA. The individual in this role will be part of a cohesive team responsible for producing GMP mRNA-based personalized cancer vaccines for evaluation in human clinical trials.


Clinical Research Associate POSITION OBJECTIVE: Work within a clinical team setting to ensure compliance with protocol and overall clinical objectives. Essential Job Functions/ResponsibilitiesParticipates in the preparation and/or review of draft protocol and informed consent documentsPossesses detailed knowledge of the study protocol and its associated activities and timelinesParticipates in conference calls, prepares agenda and summariesCoordinates with project team and other study personnel


Clinical Research Associate POSITION OBJECTIVE: Work within a clinical team setting to ensure compliance with protocol and overall clinical objectives. Essential Job Functions/ResponsibilitiesParticipates in the preparation and/or review of draft protocol and informed consent documentsPossesses detailed knowledge of the study protocol and its associated activities and timelinesParticipates in conference calls, prepares agenda and summariesCoordinates with project team and other study personnel


Safety Physician POSITION OBJECTIVE: Supports the Pharmacovigilance team in reviewing, querying, documenting and reporting on all serious adverse events (SAE) & Suspected Unexpected Serious Adverse Reactions (SUSAR) cases related to clinical studies. Essential Job Functions/ResponsibilitiesProvide timely and sound medical review of individual case safety reports (ICSR) from clinical trials.Actively participates in the case initiation process (case triage) and case data inputting/data entry

- Cranford, NJ

As a Clinical Study Monitor, you will work within a clinical team setting to ensure study compliance with protocol, FDA and ICH guidelines. Essential Job Functions/Responsibilities · Ensure the Sponsor, Investigator, and study team adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies and standard operating procedures. · Adhere to monitoring plan protocols; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring....

- Buffalo, NY

Senior Clinical Research Associate POSITION OBJECTIVE: Work within a clinical team setting to ensure compliance with protocol and overall clinical objectives. Essential Job Functions/ResponsibilitiesParticipates in the preparation and/or review of draft protocol and informed consent documentsPossesses detailed knowledge of the study protocol and its associated activities and timelinesParticipates in conference calls, prepares agenda and summariesCoordinates with project team and other study....

- Cranford, NJ

Senior Clinical Research Associate POSITION OBJECTIVE: Work within a clinical team setting to ensure compliance with protocol and overall clinical objectives. . Essential Job Functions/ResponsibilitiesParticipates in the preparation and/or review of draft protocol and informed consent documentsPossesses detailed knowledge of the study protocol and its associated activities and timelinesParticipates in conference calls, prepares agenda and summariesCoordinates with project team and other study....

- Cranford NJ & Buffalo NY, NJ

POSITION OBJECTIVE: Provide Statistical Programming Support for Clinical Data Analysis and Submission. Essential Job Functions/Responsibilities This role is expected to contribute to the quality of data analysis and reporting deliverables for phase I to III clinical trials. Provide programming support for the clinical study team by generating and maintaining patient profiles, tables, listings, figures and other types of outputsCreate annotated CRFs, mapping specifications and datasets per SDTM


Drug Product Process Engineer Small Molecule Continuous process Improvement for this leading pharmaceutical company in New England S Headquarters in Waltham, MA Looking for Senior Engineer for drug product unit operations- leadership scale-up and optimization in development from R&D to cGMP Phase 3 manufacture to process validation. Experience with continuous manufacturing, scale-up and PAT implementation is strongly desired. The individual is expected to integrate QbD principles, guide....


Top Pharmaceutical company is looking for a Senior Clinical Data Manager Contractor in their Madison, NJ office one year contract and can renew up to 4 years at a time, benefits included Description: Position Summary The Senior Manager, Clinical Data Management is responsible for leading internal and outsourced Clinical Data Management activities in support of Clinical Research studies, managing the definition of Case Report Form (CRF) requirements, creation of the Data Management Plan,....


Position Overview The Director Real World Evidence Analytics ensures that real-world evidence (RWE) studies and queries are strategically designed and optimally executed to the highest standards. This research includes data management, programming, and statistical analysis of health claims, electronic medical records, and other observational data sources. The Director also keeps current with healthcare policies, RWE data trends Biopharmaceutical industry, and other developments with other....

- Any US State

Global Pharmaceutical company is hiring Clinical Project Manager for their Clinical Development studies Day to day management of studies This position is responsible for providing oversight of Phase 1 to Phase 4 clinical trial implementation; ensuring clinical studies are conducted in a timely manner with milestones being achieved within budget.Essential FunctionsThe Clinical Project Manager for this Pharmaceutical company- will:Utilize Project Management techniques and methodologies to plan,....


Global Pharmaceutical company is hiring a GLOBAL HEAD RESOURCE MANAGEMENT AND ANALYTICS Position Purpose: Leadership role in Business Operations Management in Clinical Operations with strategic oversight and accountability for the delivery of all aspects of resource planning, capacity management & analytics (metrics) within Clinical Operations.Propose, deliver & implement resource strategies, processes, analyses and tracking for the provision of resource management information to....

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