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- Northern, CA
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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....


Strategic opportunity as North American (NA) Team Leader supporting Analytical/ Synthesis (Methods Development); Product Metabolism, Product Safety (registration); and Regulatory Compliance (EPA). Participate on the Global Leadership Team while developing a challenged, problem-solving analytical team responsible for performing/ delivering scientific studies to ensure a sustainable product safety and registration success. The successful candidate will have a strong background in Scientific....

- Any US State

RETAINED SEARCH - Dir Regulatory Affairs - Safety & Efficacy MUST have Animal Health Pharma experience Prepare Review Reg submissions FDA - CVM - INAD's - CFR - ICH/VICH - RAPS Prefer Advanced degree or DVM Virtual Office - Work remote


Represents Regulatory Affairs for pharmaceutical development projects and marketed products. Responsible for development and communication of all aspects of global regulatory strategy on R&D project teams. Leads team of regulatory professionals to assure successful planning and completion of regulatory activities on a worldwide basis. Responsible for knowledge of regulatory requirements of major regions (e.g. US, EU JP) with responsibility for working with colleagues on a worldwide basis....

- 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....


Regional Quality Leader for R&D the Americas, and is accountable for the oversight, direction and management of R&D Quality site operations and projects within the Americas. This role provides business partnership to R&D leaders to ensure that appropriate systems, procedures and resources are in place for effective execution of the R&D quality system. Functions, Duties, Task - Responsible for the execution of the global Quality Assurance and Compliance Strategy for R&D....


RETAINED SEARCH - Dir Regulatory Affairs - Safety & Efficacy MUST have Animal Health Pharma experience Pre - Approval - Submissions FDA - CVM - INAD's - CFR - ICH/VICH - RAPS Prefer Advanced degree or DVM Virtual Office - New Hire can work remote with periodic trips to HDQ

- Bridgewater, NJ

The CTM will work closely with the Director, Clinical Operations and Clinical Development team on the design, execution and oversight of clinical trials (all clinical phases) related to pharmaceutical product development and registration. The CTM is responsible for the overall operational planning and activities for the implementation and conduct of studies (clinical trials, IIT studies, compassionate use and registries) including data management activities, ensuring that clinical studies are....

- Cambridge, MA

Exciting science being performed at this Pharmaceutical company. Looking to hire two Clinical Operations Leaders under the direction of the New Vice President Clinical.he Clinical Operation Lead is responsible for developing operational strategy for one or more clinical studies, and leading the cross functional Study Management Team to align and deliver on study goals of data quality, timelines, budget and GCP compliance in support of overall program level plans. Responsibilities: The Clinical


High Profile need for Global Pharmaceutical company in NJ Assoc VP, Toxicology company is a bold, global pharmaceutical company and a leader in a new industry Position Overview The Non-Clinical and Translational Sciences organization at Company is seeking an Associate Vice President to lead our department of experienced toxicology/pathology scientists. This role has responsibility for non-clinical safety evaluation for all company pharmaceutical products, in research, development or on the....


Accountable for leading the operational study team, which is responsible for the execution and delivery of quality studies, including in-process quality control activities (e.g. quality checks and balances to ensure inspection readiness, enrollment, metrics, milestones, timelines and budget). This position requires advanced knowledge of the functional disciplines necessary to guide the operational objectives to ensure execution and delivery of quality studies within defined timelines and....

- 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....

- Cambridge, MA

Global Company is hiring a Senior Leader Clinical Operations Biotechnology company specializing in the detailed structural analysis of complex drugs and is headquartered in Cambridge, MA. Company is applying its technology to the development of generic versions of complex drugs, biosimilar and potentially interchangeable biologics, and to the discovery and development of novel therapeutics for oncology and autoimmune indications This position will be responsible for initiating and leading....


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,....

- Tacoma | Seattle, WA

VP of Compliance - Seattle/Tacoma ________________________________________________ Leading healthcare enterprise - excellent team work - generous relocation package. Experienced leader and relationship -builder with a successful career in health plan compliance will have an opportunity to continue the already successful programs and contribute to the continued growth in this market. The VP will work as a partner to the CEO. VP will serve as a key part of the local leadership team ensuring....


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....

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