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- Irvine, CA
new job!

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....

- Bridgewater, NJ
new job!

This position is in the Research & Development department at the corporate level, to support Global business category in its portfolio development activities. Closely collaborates with the other team members of the Global Regulatory Cough & Cold and Allergy category working on Allergy portfolio, in order to ensure the development of robust programs for global projects including the non-US requirements for the innovation projects. Responsibilities:Work with Region North America (NA) and


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....


Join a leading global organization in their Product/ Metabolism discovery and safety studies team. Requires Scientific expertise in biological or chemical sciences of environmental, plant or mammalian studies. ---Participate as Lead Scientist with expertise in Data Chemistry, analysis testing utilizing Chromatography and other relative methodology. ---Support the use of data sets to optimize study design and overall understanding of the compounds behavior ---Manage studies placed with external


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....


The (Senior) Group Director, Regulatory Affairs has responsibility, as assigned, for two functional global areas: Wound Device products as well as Pharmaceuticals and Biologic products in the USA, EU and UK. This is a unique opportunity to lead a global product category consisting of medical device and pharmaceutical products, existing and new product development with a revenue exceeding $350M and growing! Senior Director of Regulatory Affairs Responsibilities:Responsible for leading a....

- 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,....

- Irvine, CA

WPIJP00008461 - Clinical Trial Manager 09-24-2018 to 09-23-2019 WPIJP00008485 - Clinical Trial Manager 10-01-2018 to 03-15-2019 These are contingent worker situations expected to last 1 year. Qualifications - B.S. degree. - Minimum of 3 to 5 years of pharmaceuticals/biotech experience. - Minimum of 3 to 5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials. - Process and system....


Plan and prepare complex medical device regulatory submission documents for US, Canada, and EU regulatory filings. Provide support for other global regulatory filings. Utilizing detailed, in-depth understanding of medical device regulations, leads and participates in global regulatory teams, interprets regulations, and provides regulatory guidance. Supports management with regulatory programs planning and implementation of departmental strategies and policies.

- Menlo Park, CA

Qualifications - 12+ years of proven experience in clinical research and/or clinical trial operations, including a minimum of 7 years in a supervisory role managing (internal/external) clinical operations staff. - Industry experience within pharmaceutical and/or biologics and prior experience in FDA negotiations relating to the conduct of regulated clinical trials. - Comprehensive understanding of applicable clinical research regulations. Thorough knowledge of GCP, ICH guidelines and other

- 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

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....


Head of Regulatory Affairs - Clinical Research Organization Our client is a well-established, growing Clinical Research Organization (CRO), located in the DC/Maryland area suburbs. We are seeking a Head of Regulatory Affairs and Strategy to join their growing team. Our client does offer a highly competitive salary and benefits program, as well as opportunities for career development and advancement. Head of Regulatory Affairs Primary PurposeThe Head of Regulatory Affairs is responsible for....


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....

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