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Global Pharmaceutical company is looking to hire a Director of Medical Safety Irvine, CaliforniaMD (US or foreign is acceptable)2 years PV/Risk Mgt. experience is acceptableMust have aggregate reporting and clinical safety experiencewill relocate and offer very competitive salary and benefitsDirector Medical Safety We are aa bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. We are focused on developing, manufacturing and commercializing branded....


The Project Engineer is responsible for the development and implementation of control strategies and design to customer application specifications. This position requires an advanced understanding of Emerson products for hardware/software with an in-depth knowledge of advanced programming language and the ability to successfully work in a team environment. PRIMARY DUTIES Ensures that customer's system design and control application requirements are satisfied in a manner that will produce good....


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....

- Newark, DE

Staff Biostatistician (Or Senior Staff - Depending on Level of Experience) Elmsford NY or Newark, DE Competitive Salary, Bonus, 6% 401K, 4 Weeks PTO, Excellent Benefits We have a newly created opening for an experienced Senior (Staff or Senior Staff Level) Biostatistician with a longstanding client; a multi-billion global medical diagnostics/instrumentation company. They have strong revenue growth, a stable environment, very low turnover, and offer the opportunity to work on customized,....

- Elmsford, NY

Staff Biostatistician (Or Senior Staff - Depending on Level of Experience) Elmsford NY or Newark, DE Competitive Salary, Bonus, 6% 401K, 4 Weeks PTO, Excellent Benefits We have a newly created opening for an experienced Senior (Staff or Senior Staff Level) Biostatistician with a longstanding client; a multi-billion global medical diagnostics/instrumentation company. They have strong revenue growth, a stable environment, very low turnover, and offer the opportunity to work on customized,....

- Northern, CA

Responsibilities Manage, develop, and train the GCP Compliance personnel. Ensure the integrity and quality of clinical data by overseeing all routine and directed; internal and external; domestic and international GCP audits and quality reviews. Promote continuous improvements in quality systems and department infrastructure. Act as a subject matter expert and provide GCP guidance to internal departments for all phases of clinical development. Report significant and/or serious ongoing quality....

- 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....

- Wayland, MA

Essential Job FunctionsServe as the lead Clinical / Medical Report Writer contributing to a variety of documents for clinical research and regulatory purposes, including clinical research protocols, annual and final study reports, investigator’s brochures, and regulatory submissions including clinical summary reports (CSR), clinical evaluation (CER), and post-market surveillance (PMS) reports.Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate....


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....


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

- 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

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