Job Seekers

21-40 of 53 results
Sort By


Manager, Regulatory Affairs / CMCDeliver CMC regulatory expertise for clinical and marketed products to project teams.Establish CMC regulatory strategies.Ensure products are in compliance with global regulatory guidelinesPrepare and/or review all CMC and GMP related documentsSolid experience in preparing CMC sections for investigational and marketed product submissionsBS degree – 6-10 years’ experience – 3-5 as a manager.CMC reviewer experience highly desired.


Senior Director/Executive Director, Clinical Research San Francisco Bay Area The primary responsibility is to provide medical guidance, medical review, analysis and data interpretation from clinical studies. This individual will act as the primary Medical Monitor and oversee the safety of clinical programs. In addition, provide scientific support to the Clinical Development team in the development of various oncology and hematology projects. Responsibilities: Acts as a medical resource to the....


Director, Regulatory Affairs / CMC A key leadership position in the therapeutic area of Oncology. Responsibilities include all development activities, marketed products, including CMC, labeling changes, and regulatory compliance of marketed products.Position requires a leader who can generate and effectively implement all strategic initiatives and programs, and communicate the status of all work to leadership and Board of Directors.The position is global in scope and will require the....


Associate Director, Regulatory Affairs - Global / Oncology - MidwestResponsible to write and file electronic submissions, manage projects and project deadlinesCreate and implement regulatory strategy for North AmericaBe part of project decisions and as the Associate Director make the appropriate recommendations for project improvementPoint of contact with the FDA, and manages FDA meetingsBS Degree5-10 years’ experienceMust have Oncology / Hematology regulatory experienceExperience with Office....


Associate Director Regulatory Affairs, CMC – Northeast Liaison between company and regulatory agencies for submissions and CMC issuesDevelop submission strategies leading to approvals of applications.Prepare, review, and create submissions and CMC sections for regulatory filingsManage relationships with business stakeholders with responsibilities in process development, analytical development and qualityQualifications Bachelor’s Degree8+ years of relevant regulatory CMC experienceStrong....


My client seeks a manager to assist with educating physicians in academia and teaching hospitals. The ideal candidate will take on the following tasks:Create and deliver training programs for new physicians in electrophysiology, interventional cardiology, heart failure, general cardiology and surgeryEducate clients on the clinical evidence demonstrating efficacy of the productPartner with internal leadership to help create road map to expand utilizationDrive adoption by developing consultative

- Cincinnati, OH

My client seeks a manager to assist with educating physicians in academia and teaching hospitals. The ideal candidate will take on the following tasks:Create and deliver training programs for new physicians in electrophysiology, interventional cardiology, heart failure, general cardiology and surgeryEducate clients on the clinical evidence demonstrating efficacy of the productPartner with internal leadership to help create road map to expand utilizationDrive adoption by developing consultative


My client seeks a manager to assist with educating physicians in academia and teaching hospitals. The ideal candidate will take on the following tasks:Create and deliver training programs for new physicians in electrophysiology, interventional cardiology, heart failure, general cardiology and surgeryEducate clients on the clinical evidence demonstrating efficacy of the productPartner with internal leadership to help create road map to expand utilizationDrive adoption by developing consultative


Salary Range: $100,000 to $120,000/yr. base salary Requirements: B.S. Chemical Engineering required; 5+ plus years with experience doing design through installation of projects at the $100,000 level and above. Candidates must have experience in batch processing such as specialty chemicals, electronic materials, pharmaceuticals, biotech, or biopharma. Candidates could come from a pilot plant, a research setting, or a full-scale plant. Candidates should have experience with as many of the....


The Senior Automation Engineer reports to the Senior Manager of the Automation group. The position is responsible for providing project leadership and daily operation to the Automation Engineering Team. Specific duties include: Applies advanced engineering principles to the design and implementation of system modifications, experiments and/or capital projects; develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant....


Reporting to the Executive Medical Director, Medical Sciences this physician will lead early development programs in pain and neurodegenerative disorders. This physician will support trails from first-in-man studies through proof of concept while interacting with both scientists and the neurologists who are apart of clinical research team. They will work to ensure this developing neuroscience pipeline stays robust and on track. The Medical Sciences Director will be responsible for designing....

- Boston, MA

Electrical Engineer We are currently seeking an experienced Electrical Engineer to join our clients technical team. In addition to acting as the lead electrical engineer on projects, you will provide technical guidance to their junior design staff and have the opportunity to work on a range of projects.Position Responsibilities:Lead Electrical Engineer on projects.Responsible for production and review of narratives, drawings, and specifications for all assigned projects.Construction....


Top tier Pharmaceutical company (one n Boston and one in NJ nd one in Seattle)Required:Has completed management of a study or group of studies from planning through close out (Phase 3)Experience with managing VendorsExperience working on global studies with CROs Nice to Have:Experience supporting writing clinical study reports,Supporting sNDA or NDA submissions, Supporting pre-Inspection preparation,Participating in Sponsor Inspections by Regulatory BodiesExperience managing or leading teams....


Reporting to the Vice President of Biosimilars, Global Development this physician will oversee the inflammation biosimilars portfolio, as well as the head of the biosimilars scientific affairs team. They will also serve as the Global Development Leader for clinical development of key assets. This role is for a physician with eight plus years of industry clinical research experience. This physician should have completed an accredited fellowship in relevant specialty or sub-specialty. It is....


Manages the Quality Control Chemistry laboratory operation, ensuring laboratory processes provide high quality analytical support for manufacturing, maintenance, engineering and validation operations while ensuring compliance of protocols, GMPs, and safety regulations. Provides broad-based QC Chemistry expertise and counsel to and on behalf of the organization.Provides leadership, management, and training and career coaching for QC staff.Responsible for the management, guidance and training of

- San Francisco, CA

Outstanding opportunity for a Director of Quality for Clinical GCP. My client is seeking a talented Clinical Quality professional who has significant experience in ensuring that Clinical Trials are in compliance with Good Clinical Practice (GCP). Reporting in to the VP, this individual will be responsible for ensuring quality systems, procedures and documentation are in compliance with applicable US and international standards and regulations. While this is initially an individual contributor....


Our client, a Major Global Pharmaceutical Company, is actively expanding their operations in the U.S. They are currently looking for a Manager/Sr. Manager, Regulatory Affairs. The Manager/Sr. Manager will be responsible for submissions (IND/NDA/BLA) from Cradle to Grave - as well as the development and execution of global regulatory strategies. The ideal Candidate will also have some direct experience communicating with the FDA and various other Global Health Authorities. Additionally the....


SOFTWARE TEST ANALYST - JAVA BASED SOFTWARE PRODUCTS Columbia MD REQUIREMENTS:3+ years of software development and /or software testing experienceDemonstrated knowledge of Java, Javascript and AJAXRDBMS experience with SQL Server and/or OracleAPI testing experienceObject Oriented Programming (OOP OOD)Experience testing large data setsExperience with internet and web technologiesExperience working for a software product teamAgile environment WHAT YOU WILL BE DOING IN THIS ROLE The person....

- Western, MI

Company:Strong collegial group of people with a very strong team-minded cultureFast-paced work environment on highly technical projectsVery community-minded with a strong sense of giving back to the community with time and talents for charitable organizationsVery strong work-hard, play-hard mentality with fun events outside the officeCompany has grown nationally and this office is slated for growth as wellPrivately-held- you won't be a number hereNationally recognized for innovative,....


Our client - a growing Pharmaceutical company in Raritan, NJ is looking for a Manager - Regulatory Operations. The Manager - Regulatory Operations will be responsible for development and implementation of procedures and systems to support Regulatory Submissions and Regulatory Publishing. The Manager will also be responsible for the establishment and maintenance of an archiving/document management systems and tools (e.g. eDMS, Regulatory Information System, CTD templates, etc.). The Manager....

21-40 of 53 results
Unless noted above, applicants MUST be authorized to work in the US without Visa Sponsorship. US citizens and Green Card holders ONLY. We do not provide relocation assistance for those living outside the continental US. Please only click apply if you meet the specific requirements of the job listing, you are able to work in the location listed, and are comfortable with the salary range indicated above. Thanks for your interest. We look forward to working with you.