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- Charlotte, NC
new job!

We are looking for a Senior Regulatory Affairs Manager who will play a primary and integral role in the regulatory activities and initiatives at the facility. Incumbent will guide US regulatory strategies across multiple programs at this emerging facility, lead pre and post-approval submission activities, and serve as regulatory lead to interdisciplinary cross-functional groups across entire product life cycles. Key Responsibilities:Coordinate ANDA submissions to FDA, interact with regulatory....

- Gaithersburg, MD
new job!

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....

- Tacoma | Seattle, WA
new job!

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....

- Denver, CO
new job!

Outstanding opportunity for a Corporate Environmental Management Director, who will be responsible for providing strategic leadership and direction in the planning, development, implementation and evaluation of the environmental affairs for the Global Chemical Leader. You will be responsible for establishing the vision, strategy and execution of environmental programs and management systems to identify and minimize environmental risks and liabilities ensuring compliance with all applicable....


If you are an experienced Food Safety Manager in the prepared/packaged food industry and are looking for an opportunity to make an impact, this may be the place for you! Top 5 Requirements: 1. Bachelor’s degree in Food Science, Microbiology, Biology or related field is Required.2. Product experience should include food products.3. Technical knowledge of food safety, food science, and regulatory requirements is a must.4. Ability to demonstrate an understanding of process control methods and....

- Owensboro, KY

QUALITY ASSURANCE MANAGER We have a unique opportunity to join our team as a QA Manager of one of our food processing plants. Our company is a privately held, family friendly culture with over 50 years of experience serving our customers. We provide high quality, packaged food to the retail, food service and contract packaging markets. Our retail brand has been consistently growing for over 2 decades and we are searching for a leader in Quality to help us continue to propel our company forward

- Chadds Ford, PA

General Summary: Provides executive leadership and direction for formulation, technical manufacturing development for equipment, and manufacturing operations. The primary responsibilities include increase operating efficiency through improved formulas, machine set-up and efficiency, technical affairs associate with manufacturing pilot lab and standard operations. Directs: development, communication and implementation of policies, procedures, systems enhancements, budget, capital expenditures....


Vice President, Compliance (WA)Ensure regulatory compliance with state and other government agencies related to the health insurance industry, and its business subsidiaries. Report directly to the COO. Develop and implement a strategic vision for compliance and ethics culture within the business unit ensuring alignment with CorporateEnsure business unit is in compliance with state and federal program regulations, insurance regulations, regulatory requirements for business entities and state....


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,....


Three Medical Directors needed The Medical Director is a board-certified physician who has a history of clinical practice, and has significant experience in the cardio therapeutic area, Endocrinology or Renal, Nephrology therapeutic areas. The Medical Director is knowledgeable of the actions of regulatory bodies, in particular FDA, and has experience in clinical trials. An ideal candidate should have significant experience in renal cardio disease management and would thrive on proactively....

- 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 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 –....


Director, Medical Information 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 experimental design with a focus on process....


Global Pharmaceutical Company is hiring three Clinical Operations Directors (Vaccine or rare disease or Oncology) This position will be responsible for initiating and leading phase 1 and 2 clinical trials development, set-up, implementation and completion. This will be accomplished by working with the internal project team and through a preferred provider CRO and other external contractors. This role will report internally to the Head of Clinical Operations and work closely with the Regulatory


The Senior Manager, Clinical Development CNS will participate in internal process improvement activities within R&D and Clinical Development. Main Areas of Responsibilities supports the Clinical Program Lead and Clin.Sci. Lead in the development of the Clinical Development Plan and associated clinical trial content (e.g., protocols, IBs/IDFUs, CRFs, CSRs, regulatory submissions and publications) by contributing to scientific/clinical information aligned with the strategy. key Clinical....


The 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 Operations Lead will independently plan all aspects of the clinical operations for one or more clinical studies and oversee the execution of studies keeping the....


The Director/Sr. Director of Clinical Development Operations is responsible for clinical operations planning, oversight and execution of multiple studies within one or more clinical development programs. Strategic development and coordination of operational approaches, guiding study level staff, and optimizing vendor performance. Sophisticated internal (cross functional team members) and external (KOLs, site staff) stakeholder communication and interface. Manage and/or mentor Clinical Trial....


Senior Clinical Research Associate (In House) Norwood, MA - No Remote Option Competitive Pay, 8% bonus, 6% 401k, 4 weeks PTO Relocation assistance available Every year, healthcare systems run millions of clinical tests to help identify the causes of certain symptoms their patients are experiencing. The Point of Care marketplace is rapidly growing/evolving, with cutting edge technology, machines, and rapid testing solutions at physicians fingertips. We have a unique opportunity (newly-created,....

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