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Open CMC (Pharma) position ... Direct technical CMC for drug development projectsHas had: Hands on Formulation / Process DevelopmentPost approval maintenance of productsTroubleshoot manufacturing with CDMO's Assess manufacturing changes Maintain CMC, DMF, GMP-QA electronic filesStrong chemistry backgroundSmall moleculeHow studies need to be runResponsible for preparation of post approval supplements and other regulatory documents Tired of working hands on in the Lab then this position may be....


This position in the Clinical Programs department will be based in the Midwest, preferably in Minnesota, and is responsible for day-to-day field implementation of companies multi-center clinical investigations in accordance with corporate objectives, EU and FDA guidelines and protocols. The Field Clinical Engineer (FCE) is the primary site contact with respect to study recruitment, patient selection, and implant procedure support, requiring excellent clinical and technical skills. This....


Great opportunity to join a Global Company as the strategic North American (NA) Team Leader supporting Analytical/ Synthesis (Methods Development); Product Metabolism, Product Safety Standards; 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


Are you a BC MD or DO BC by an Approved ABMS Board certification by the American Board of Pediatrics, Primary Care and/or Family Medicine . Current state medical license without restrictions. This is and outstanding opportunity for someone who is interested in working a Utilization Review role in the Atlanta region. It is a plus if you have Medical Director experience or even experience working with a health plan company. To be considered you should have: * experience working with medicare and


Large Global company is expanding their St. Louis team- They are in need of and Executive Director, Development In addition to a generous base salary: there is a bonus (30%) there is Equity Stock Grant Program and also Executives at this level have Stock purchase plan: (they can buy Stock options and company matches 75%) 3 weeks vacation PLUS – they ar eclosed during Christmas and New Years They will prvide FULL relocation This role reports into VP, Product Development Need Product Design....


Our client is a producer of Bio-pharmaceuticals. They have developed core competencies in the development of processes and products derived from natural sources both animal-based and plant-based. They have an immediate opening for a Regulatory Affairs Specialist. RESPONSIBILITIES:This position will provide regulatory support for development and commercial programs.In this role, you will plan, coordinate and oversee regulatory activities.These activities include the preparation of document....


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....


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.....


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....


This is a key position that will have product development oversight responsibility for Design Control as the product moves through the development stages to commercialization. Key liaison between Product Development, Quality Engineering, and Regulatory Affairs. Maintain focus on VOC requirements as defined by Marketing. Required Background & Experience:MEDICAL DEVICE PRODUCT DEVELOPMENT EXPERIENCEBS degree in a technical discipline, preferably engineering. Advanced degree is a plus.Strong....

- Palo Alto, CA

The Senior Director is primarily accountable for nonclinical toxicology, working in collaboration with nonclinical pharmacology and pharmacokinetic scientists to drive the overall global nonclinical regulatory submission strategy and coordination for multiple portfolio products, from research to registration and beyond. The individual has experience in evaluating and responding to inquiries from regulatory authorities addressing global nonclinical development issues in support of IND and....


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


Global Pharmaceutical company is expanding in new offices in Madison, NJ This Clinical Trial Manager is an essential part of the Clinical Operations team. Looking for a strong Clinical Trials Professional with a operation experience for phase 2, 3 and 4 trials. Multiple therapeutic reas. -responsible for the delivery of studies , responsible for the execution and adherence of various aspects of the study operational plan (start up, conduct, close-out, and vendor oversight) with input from key....


Strategic New Products/Marketing Director role in Greater Philadelphia Area - Exciting High Level New Products/Marketing Director role with a Cutting Edge Medical Device manufacturer that has new technology with high end growth potential ! Strategic New Products/Marketing Director will provide commercial input to the advancement of product concepts through the new product development process including providing insights and voice of customer, developing the business case, implementing target....


Global Pharmaceutical company in Madison, New Jersey is looking for a Pharmacovigilance Agreements & Alliance Management Specialist We are looking for candidates with a PharmD or RN/NP with individual case safety report processing experience and knowledge of global drug safety/PV regulations, i.e., Drug Safety Associate/Sr. Associate/Manager. I. POSITION SUMMARY: The PV Agreements & Alliance Management (PAAM) Specialist guides and facilitates effective working relationships with....


New need for Growing Global Pharmaceutical Company in New Jersey Contract R&D Project Planner III This R&D Project Planner is responsible for supporting Clinical Trial/Project Teams by strategically developing and maintaining clinical study timelines, providing evaluations of potential risks and conflicts, supporting the team on proactively resolving potential deviations, and presenting clear timeline reports. PP will work in a team orientated environment and is empowered to drive....


Publicly Traded Top Tier Global Pharmaceutical Company is looking for a Clinical Study Manager or Senior level DOE to be located in their Cambridge, MA Headquarters competitive base salary and bonus, full relocation and stock and other long term incentives! This role requires a strong communicator: Duties and Responsibilities: 1.Manage clinical study/studies according to global regulatory requirements (including but not limited to US CFR, EU CTD, and ICH GCP) and Company SOPs, and supporting....


New contract role (opportunity to convert to perm in future if desired) with Global Pharmaceutical company located in Cambridge, MA BACKGROUND: This Drug Product is an ALK Inhibitor for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic NSCLC. It was recently approved by the FDA under Accelerated Approval in April 2017, based on tumor response rate and duration of response, for previously treated anaplastic lymphoma kinase-positive (ALK+) metastatic....


Our mid-sized client is looking to add a Principal and Sr. Compliance Specialist to add to their growing team. The main responsibilities will be Field Corrective Action (FCA) and Recall Management for Medical Devices. Will be leading teams to develop field corrective action and recall plans. Oversee execution and reconciliation of field corrective actions and recalls. Working with cross-functional partners to determine root cause and population bounding as well as with Health Hazard....

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