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- Cranford, NJ
new job!

Global Pharmaceutical company is hiring a \ for their growing company. Our Clinical Trainer is responsible for identifying and implementing Clinical Development staff training needs. They may benchmark Clinical SOPs and insure SOP training is completed and up to date. The Clinical Operations Trainer may also periodically co-monitor and evaluate staff performance and provide guidance for performance, improvement and adherence to FDA and SOP requirements. They may liaise with US and Taiwan....


Global Pharmaceutical Leader is looking for consultant (all levels) Clinical Managers for their growing Clinical Development team 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....


The Manager Regulatory Affairs will be responsible for the following: Leading the preparation and filing of regulatory applications (IND, NDA, BLA).Coordinating/meeting with various functional areas in order to identify and obtain information required for regulatory submissions.Developing and/or reviewing regulatory documents (IND, NDA, BLA) in order to ensure that all submissions are of high quality.Leading the preparation of responses to questions from Regulatory Authorities.Developing and....


Join a Global Company as the strategic 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....

- Pittsburgh, PA

Director of Regulatory and Clinical Operations The ideal candidate will take on the following tasks: · Contribute to the strategic planning of the company’s regulatory affairs · Lead the implementation of the company’s regulatory strategy and provide evidence-based opinions and advice · Manage all relations with FDA and 510k submission · Provide management with continuous input on regulatory matters and their interactions with business development, clinical development, commercialization,....


Top Tier Global Pharmaceutical company is expanding and looking for two Medical Director (for Clinical) must be Medical Doctor with MD degree Can have experience in oncology or even internal medicine and have experience with clinical development. Competitive salary and benefits and bonus, 401k, long term incentives and short term incentives and more Provide medical support for the study team:Global primary contact person during the course of the study for medical;Responsible for content of....


Director of Regulatory The ideal candidate will take on the following tasks: · Contribute to the strategic planning of the company’s regulatory affairs · Lead the implementation of the company’s regulatory strategy and provide evidence-based opinions and advice · Manage all relations with FDA and 510k submission · Provide management with continuous input on regulatory matters and their interactions with business development, clinical development, commercialization, financial planning,....


Global Pharmaceutical company in Northern NJ is expanding and is looking for Packaging Mechanic Serialization Our company is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmic, injectables, oral liquids, OTCs, topicals, inhalants, and nasal sprays. We market our products to....


Join a global leader as a Eco-Toxicologist responsible for conducting quantitative environmental risk assessments for agrichemical and fertilizer products and traits in North America. You will provide technical advice on study designs for regulatory and research oriented studies as well as advice to support new and existing registrations of client products and traits. --- Work closely with regional/global regulatory and product safety teams as well as other functional teams to produce risk....


Global Pharmaceutical Company out of Madison, NJ and Irvine, CA Position Summary: (Irvine, CA or Madison, NJ) Responsible for leading internal and outsourced Clinical Programming activities in support of Clinical Research studies and managing the design, development, validation, implementation, and oversees ongoing support to electronic case report form (eCRF) systems (e.g. InForm, etc.), external data acquisitions, reporting/business intelligence tools (e.g. SpotFire, J-Review), and other....

- Clearwater/St. Louis, MO, FL

Assistant or Associate Director, Regulatory Affairs- Medical Device/CMC Position can be located in either the St. Louis, Missouri office or their Clearwater, Florida office relocation is provided Candidate MUST have Medical Device experience and must have written CMC submissions in the past (recent past is preferred) Individual Contributor role Specialty and Diverse Pharmaceutical company is adding to their high profile team competitive base salary, plus bonus, full benefits and other Long....


Global Pharmaceutical company with high profile trials is expanding and looking for a Director, Regulatory Affairs for their Global Management Team Competitive base salary and bonus, full relocation and benefits, Long Term Incentives and more Position IDEALLY is located in the Cambridge, MA office (there is small possibility the role can be based in their NJ office) The Rare Disease Global Regulatory Team Lead (GRTL) is part of the Global Regulatory Affairs (GRA) team based in the US. He/she....


Our client is a major worldwide consumer products company, ranked in the Fortune 200. Indeed.com identified them as one of 25 of the biggest and brightest corporations that are going the extra mile to help employees achieve the elusive “work-life balance.” Fortune Magazine identifies them as one of the top 50 World's Most Admired Companies. Position Summary: This key corporate food safety position plays a critical part by participating in strategic planning & addressing major Company....


High Profile Drug Development Pharmaceutical Company is expanding: Global Category Director- Drug Development Services Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future Join us as a Global Category Director – Outsourced Drug Development in our Cambridge, MA office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Global Category Director

- Lancaster, SC

Summary of the Position:. Develops and deploys the quality system for entire manufacturing facilities to assure systems and procedures are compliant pursuant to government regulations, industry standards and Company specifications and policies. Periodically reviews the suitability and effectiveness of the quality systems with Executive Management. He/She has ultimate responsibility for making the quality decisions on the identity, purity, strength or composition of nutritional products in the....


Global Pharmaceutical company is expanding: OBJECTIVES: - The Project Manager is required to identify and resolve project risks with proposed resolution plan (ad hoc and planned), with escalation to senior stakeholders where appropriate. - They will execute their day-to-day activities in line with company Category Management Framework, with a strong focus on strategic sourcing initiatives which aim to qualify and select suppliers that meet the needs of the business at maximum financial....


DIRECTOR / SENIOR DIRECTOR, REGULATORY AFFAIRS – CMC Our client, a progressive biopharmaceutical company, has a new opportunity for a Senior Director level Regulatory Affairs professional with CMC expertise in the San Francisco Bay area, to drive US and Global Regulatory projects. This is a full-time Senior Director level role with a primary focus on the discovery and development of oncology drugs. Independently manages all regulatory CMC business for oncology products throughout lifecycle.....

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