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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,....

- South Bend, IN

COMPANY BACKGROUND: A research laboratory that has been manufacturing & distributing a variety of enzymes & cofactors used in basic coagulation research for over 30 years. Their diagnostics division/sister company provides general purpose & specialty assays to the clinical coagulation laboratory; the laboratory incorporates the research laboratories high purity proteins & reagents into clinical diagnostic kits. POSITION OVERVIEW: This research laboratory seeks an energetic....

- Baltimore, MD

Our client has helped revolutionize the liquid packaging industry by manufacturing custom liquid filling and packaging machinery systems for the pharmaceutical, biotech, diagnostic, healthcare and cosmetic industries. Reasons people like working here:The company is innovative, develops high-tech equipment and has been successful for over 50 years.You receive full responsibility for the complete electrical control systems portion of the project, not just bits, and pieces of the....


The Project Manager - Clinical will be involved in the following: Responsibilities include but are not limited to:Setting project priorities/milestonesDeveloping/tracking study timelines and budgetsProactively identifying and resolving issues, and participates in process improvement initiatives as requiredProviding prompt feedback to any questions and issues raised by clients, vendors, consultants, etc.Managing/initiating auditing projects from inception through final audit reports. The....

- South Bend, IN

COMPANY BACKGROUND: A research laboratory that has been manufacturing & distributing a variety of enzymes & cofactors used in basic coagulation research for over 30 years. Their diagnostics division/sister company provides general purpose & specialty assays to the clinical coagulation laboratory; the laboratory incorporates the research laboratories high purity proteins & reagents into clinical diagnostic kits. POSITION OVERVIEW: This diagnostics division seeks an energetic....


OverviewThe company is proud to have been recognized as one of The Boston Globe’s Top Places to Work in 2015, 2016 and 2017. Responsible for leading Process Automation System (PAS) implementation at new Greenfield facility. Work with cross-functional teams on developing system requirements, managing System Integrator project to implement and test, and oversight of all Commissioning and Qualification needs during facility startup. Assist in overall company standards and capital planning around....


Global Specialty Pharmaceutical company in Bridgewater, New Jersey is looking to hire a Manager of Clinical Quality AssuranceThe Manager Clinical Quality Assurance is a key member of the company Research and Development organization. This role is responsible for Clinical QA activity related to the planning, conduct, and reporting of GCP audits in order to ensure that clinical studies are conducted in compliance with applicable regulations, guidelines and company standards. This role also has....


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....


High Profile Pharmaceutical company with recent FDA one of a kind approval is hiring a Senior Manager of Regulatory Affairs CMC Reporting to the director technical writing of RA CMC of Regulatory Affairs, the Senior Manager of Regulatory Affairs, CMC will be responsible for the preparation of high quality regulatory submission content focusing on CMC to support global clinical development, registration, and product life cycle management in accordance to regulatory requirements and guidelines.....


The Rare Disease Global Regulatory Team Lead (GRTL) is a Director-level role which is part of the Global Regulatory Affairs (GRA) team based in the US. He/she is responsible for developing long- and short-term regulatory strategies that impact company’s business objectives. Specific responsibilities include: Global Regulatory Team Lead (GRTL) is responsible for developing global regulatory strategy for projects in his/her remit, which include both pipeline and life cycle management programs.....


Pharmaceutical company is hiring an Associate Director Medical Writing for their Waltham Massachusetts location.We are a leader in innovative medicines that address the unmet needs and challenges of people living with debilitating diseases. As a fully integrated global biopharmaceutical company, we apply our scientific expertise, proprietary technologies, and global resources to develop products that are designed to make a meaningful difference in the way patients manage their disease. Our....

- 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.


Top Tier Pharmaceutical company (with focus in Cardio, respiratory, CNS, Psych and more) in Madison, NJ is looking for a new Director, Clinical Development for to add to this growing team!The Director Clinical Development will report directly to the Vice President and is responsible for the scientific, strategic, therapeutic, and operational management of programs to evaluate, register, and market pharmaceutical agents. Lead and direct study programs, activities, and teams for one or more....

- Buffalo, NY

Clinical Project Manager As a Clinical Project Manager (CPM), you will work in a matrix management environment and serve as the primary contact for interdepartmental and external study contacts. This experienced CPM role is responsible for managing all stages of a clinical study within GCP and ICH guidelines when direct management by the sponsor is required. The CPM may also function as the liaison and provide support for sponsor managed studies in an international setting, and, may oversee....


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....

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