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This position entails development of submissions in conjunction with other BDI Surgery departments, requiring working knowledge of products under review and of relevant regulations and guidance documents. Also, this position is responsible for writing, supporting, and assisting in gaining approval of product registrations and other submissions to International Business Centers. Qualifications: Bachelors's degree required (healthcare industry) 5-7 years of international regulatory experience....


Looking for candidates with regulatory affairs experience supporting R&D IVD, leading RA projects for new product developments Regulatory Affairs Specialist is responsible and accountable for developing and executing sound strategies for regulatory submissions and registrations for complex new product development projects. This position interfaces with multiple projects and functional teams with limited oversight, provides instruction, guidance, and regulatory interpretations to functional


Overview: The Surgical Regulatory Affairs Sr Manager handles all regulatory development aspects of surgical devices. The incumbent participates on the product development team to provide regulatory guidance for surgical devices assigned. They also manage relevant regulatory strategy components and interactions with Regulatory Authorities for their assigned surgical products and may perform due diligence efforts on new product opportunities. Responsibilities: Responsibilities may include but....

- New Brunswick, NJ

Our client is a leading global manufacturer of specialty chemicals used in a wide variety of consumer and industrial applications. We are conducting a search for a Regulatory Manager for their expending business headquartered in the New Brunswick, NJ area. Reporting to the Vice President of R&D this individual will be responsible for managing the PSRA group plus developing and implementing their regulatory compliance strategy for their worldwide operations. This will include:Implementing....


The position is responsible for planning and preparing complex medical device regulatory submission documents for US, Canada, and EU regulatory filings. Provides support for other global regulatory filings. Utilizing detailed, in-depth understanding of medical device regulation leads anticipates in goal regulatory teams, interprets regulations, and provides regulatory guidance. Support management with regulatory programs planning and implementations of departmental strategies and policies.


Our client seeks a Clinical Research Operations professional to plan their Phase I Clinical Trials Requirements Bachelor’s Degree in life sciences or healthcare field. Additional coursework in clinical trial design.Ability to travel as required (up to 25%).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....


The Systems, Analytics and Reporting Associate oversees and ensures the successful execution of tasks related to the reporting and visualization of metrics and analytics for clinical, functional, and business operations areas. The Associate is also responsible for metrics, reporting, collection of requirements, leading of meetings, and generation of dashboards or reports. Requirements BS/BA degree in Computer Science, Life Science or Engineering (2-3 years experience) Spotfire experience....


The Regional Sales Manager is responsible for managing the sales representatives and the sales activities of the Particle Characterization, Rheology, and Nanomaterials Testing product lines within the Western Region (eleven western states). This position reports to the Regional Vice President. Responsibilities & QualificationsAssists the Vice President of the region to build sales territories within assigned region.Interviews, makes hiring and firing recommendations, develops new hires,....


Here are excellent opportunities with a new food products plant, a division of a thriving national company, located in Wooster Ohio. 2 great Jobs are available on 2nd Shift. 2nd shift positions are either Sun-Weds, or Weds-Saturday, 3pm-1:30am. Quality Assurance Analyst -- $50-65,000 -- experience with SQF in food or dairy or beverage or pharma manufacturing -- relocation paid! Wooster, OH Currently looking for Quality Analysts to fill openings with a new food products plant located in....

- Lancaster, SC

We are looking for a Quality Control Chemist to perform release and stability testing on raw materials and finished products following Standard Operating Procedures (SOPs), in-house test methods, and/or compendial methods. GENERAL RESPONSIBILITIESTrain in the operation of the following instrumentation: Laboratory Balances, High Performance Liquid Chromatographs (HPLCs), Gas Chromatographs (GCs), Automated Titrators, and Dissolution and Disintegration Instrumentation. The operation of....

- Pasadena, CA

Clinical Data Coordinator A newer Biotech company with a growing, innovative, science driven team. As process owner, the Clinical Data Coordinator, manages in-house data management activities (including vendor management) to ensure the accuracy and consistency of clinical databases for subsequent analysis and reporting. In addition, the position is responsible for building programs to create datasets, listings, tables and figures from clinical databases, external data sources, and other....

- Dayton, OH

The successful R&D Manager will serve as part of the North American business leadership team and will be responsible for all product innovation, laboratory development and technical service activities. The R&D Manager will understand and collaborate with internal functions such as manufacturing, sales, marketing and customer service while also interfacing with external customers, industry organizations, etc. Key responsibilities will include:Implement strategy, policies and tactics for


Overview Our client is seeking an External Innovation Expert (Scientific R&D) who will work with the company’s R&D to manage complex, cross-functional initiative efforts that require integration and distillation of inputs into a singular, cohesive view. The company may acquire, co-develop and/or invest in new clinical stage assets that enhance their portfolio and exposure to new innovation, resulting in tighter integration of internal R&D efforts with BD. Job type: W-2 contract....


This unique opportunity reporting to the Vice President, Clinical Development will have a significant role in developing life transforming therapeutics for patients with rare diseases. Looking for a capable, insightful, practical, experienced and skilled physician leader to help plan, develop, execute and analyze clinical study programs in rare bone diseases. The best candidate can manage appropriate protocol development, endpoint development and effective reporting of results, adequate....


The associate works cross-functionally to project manage the review process for advertising and promotional materials for approved drug products. The associate is responsible for ensuring the efficiency of the Promotional Review Committee (PRC) process, involving Legal, Regulatory and Medical teams, and for conformance with company policies and procedures. Key Duties: Ensure that all SOP requirements are met Manage all aspects of the review process for multiple brands Lead and manage....

- Waltham, MA

TOP TIER PHARMACEUTICAL COMPANY in MASSACHUSETTSglobal biopharmaceutical company developing innovative medicines The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates Position SummaryWe have the need for a highly collaborative, experienced Manager of Medical Writing Operations to join our team based in MA. The position reports into our Director of Medical Writing and will lead writing responsibility of documents which ensure....


High Profile Pharmaceutical company with recent FDA one of a kind approval is hiring a Senior Manager of Regulatory Affairs CMC Reporting to the director technical writing of RA CMC of Regulatory Affairs, the Senior Manager of Regulatory Affairs, CMC will be responsible for the preparation of high quality regulatory submission content focusing on CMC to support global clinical development, registration, and product life cycle management in accordance to regulatory requirements and guidelines.....


Global Pharmaceutical company is hiring an Executive Director to head up their Renal Medical Affairs Division this Executive role will report into the Executive Vice President of Medical Affairs and spear head the high profil department must be Nephrologist with at least 3 years of medical affairs experience Renal Cardio Medical Head (Executive Director) The Renal Cardio Medical Head is a member of the Renal-Cardio Therapeutic Area (RCTA) leadership team and leads the Renal Cardio Core Medical

- Any US State

Pharmaceutical company hiring MSLs- GI and Pain and Addiction There is three openings for an MSL in Pain and Addiction to cover the whole United States in the: East, Central and West. There is one openings for an MSL in GI for Texas region only please only apply if you have previous and recent Medical Science Liaison experience for the pharmaceutical or biotech or medical device industries looking for three or more years of experience as an MSL The Medical Science Liaison (MSL) plays a crucial


Top Tier Pharmaceutical Company hiring Endocrinologist Field Physician or Senior Field Physician Endocrinology and Diabetes A Field Physician/Sr. Field Physician US Medical Affairs, is a board-certified endocrinologist who has a history of clinical practice, who has significant experience in the therapeutic area of endocrinology and secondary prevention. They will have solid peer relationships with key opinion leaders in their therapeutic area (TA). An ideal candidate should have significant....

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