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GLOBAL PHARMACEUTICAL COMPANY IS HIRING A HEAD OF MEDICAL AFFAIRS FOR RENAL Renal Cardio Medical Head (Executive Director) The Renal Cardio Medical Head is a member of the Renal-Cardio Therapeutic Area (RCTA) leadership team and leads the Renal Cardio Core Medical Team. The position can be either a Senior Director or Executive Director based upon the individual's experience. The Medical Lead is knowledgeable of the actions of regulatory bodies, in particular, knowledge of the FDA. He/She has....


Senior Scientist-Chemicals-fatty acids (1385) Location Minneapolis, MN Summary This role will perform testing of materials to determine their performance and will evaluate how organic and fatty acids are used in industrial applications, along with looking for new development areas. DutiesEnsure safety requirements are metEvaluate business opportunitiesWork with internal teams to educate on the uses of the compounds RequirementsBS Degree, MS or PhD preferred5+ years minimum related industry


Device Development Leader is high impact position for leading development of product device strategy, including technology/platform choice, partner/vendor selection, clinical strategy, regulatory strategy. Requires talented leader with proven expertise in overseeing cross-functional global team activities and to be knowledgeable about overall device development activities. As leader of device development subteam, accountable for device program execution ensuring the translation of product....

- Waltham, MA

TOP TIER PHARMACEUTICAL COMPANY in MASSACHUSETTSglobal biopharmaceutical company developing innovative medicines The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates Position SummaryWe have the need for a highly collaborative, experienced Manager of Medical Writing Operations to join our team based in MA. The position reports into our Director of Medical Writing and will lead writing responsibility of documents which ensure....


Leading Global Pharmaceutical company with office in Waltham Massachusetts Manager, Health Economics & Outcomes Research (HEOR) Position Summary: The Manager for Health Economics & Outcomes Research (HEOR), will be responsible for supporting HEOR activities for company's products. This individual will contribute to evidence generation, development of strategy, data analysis and dissemination and support the HEOR Senior team members (Directors, Senior Directors).....


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....

- Lancaster, SC

We are looking for a qualified individual who has the understanding and knowledge of development of chromatographic, spectroscopic, titrimetric and wet chemistry methods. Implements strategies to ensure effective achievement of scientific objectives. Monitors and evaluates completion of tasks and projects.Roles and Responsibilities:Has hands on knowledge and can begin the development and validation of scientifically sound analytical methods for Product release and stability testing.Familiarity

- Any US State

The Senior Director, CMC Regulatory Affairs will be responsible for providing CMC regulatory leadership and strategy across the organization and to our global partners. The Sr Director, CMC Regulatory Affairs will collaborate with the clinical development team, including the Chief Scientific Officer and drug substance and drug product manufacturers, and others for drug development and manufacturing in the pharmaceutical and biotech industry in accordance with the protocol, standard operating....


Position Overview Plans, directs, and executes product formulation and process development activities in support of development of new products intended for clinical trials and commercialization with focus solid and liquid dosage forms including immediate and controlled/modified release systems. Conducts research in the area of formulation sciences in support of innovative product development both for new chemical entities and life-cycle management of marketed products. Experience in the....


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,....

- Morristown, NJ

Our Client - a growing NJ Based Pharma company with a focus in Oncology - is looking for a Director Clinical QA This person will be responsible for the management/evaluation of compliance of clinical studies for both the FDA as well as international health authorities. This position will focus on the following activities:Managing clinical records & documentation systemManaging improvements of GCP processesManaging internal audits Assisting with inspection readinessManaging the GCP training


Assist in the development of and implement the data management plan for clinical trials. * Pepare data reports, tables and graphs for regulatory submissions, IRB submissions, presentations and publications. * Maintain traceability of data sets used for various reports. * Perform consistency checks and data cleaning functions. * Review data on a regular basis for trends and relationships. * Liaise with Clinical and Scientific research teams on data presentation. * Interact closely with....


Director of Clinical Development Cardio This global Pharmaceutical company is the worldwide biologics research and development leader. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a Director, Clinical Development in Gaithersburg MD or Cambridge UK, you’ll play a pivotal role in....


This role is for a physician who is excited to help implement a US Medical strategies for a product launch in the migraine space.This physician will be apart of the team providing strategic input and oversight on the development and life cycle management for a monoclonal antibody targeting a novel pathway for migraine. This is a high profile asset getting some impressive results in on-going trials. This is the opportunity to join a growing Neuroscience Therapeutic Area that has commitment from

- 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....


Global Pharmaceutical company is looking for a Clinical Partnership Liaison Must have pharmaceutical, Biotech or CRO experience at this senior level. located in NYC must work in the office three days/week The Partnership Liaison is a key leadership role within Clinical Operations Business Operations Management. The role is responsible for implementing and driving the success of the Clinical Development sourcing strategy. The role is accountable for Clinical Development alliances with clinical....

- Jersey City, NJ

Pharmaceutical company in Jersey City, NJ in need of Clinical Research Associate Responsible for monitoring of single and multi-site clinical trials. Assures adherence to international Commission on Harmonization (ICH), Good Clinical Practices (GCP), and Code of Federal Regulations (CFR). Assures compliance with institutional Standard Operating Procedures (SOPs) and Policies, protocol requirements, and institutional reporting requirements. Performance of this position requires coordination and


Top Tier Pharmaceutical company (with focus in RESPIRATORY, CNS, Diabetes, Cardio, GI and more) in Madison, NJ is looking for three Clinical Trials Manager Consultants for Clinical Trials Group This is a one year contract and can continue for up to 4 years (1099 or w-2)SummaryParticipate in all aspects of clinical development and study management under the direction of the Director, or designee, which includes providing scientific, and/or logistical support to planned and ongoing trials CTM –....


Pharmaceutical client in NYC hiring two Clinical Research Study Managers for their Global Trials The Clinical Research Study Leader (CRSL) will provide leadership to global Study Management Teams responsible for delivering First in Man, Proof of Concept through to Phase 3 registration studies in various indications. The CRSL will manage a number of studies, either for a single indication or across different indications. The CRSL is accountable for the strategic and tactical study activities,....

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