- Insulet Corporation (Acton, MA)
- …programming, as implemented in C* RTOS knowledge and experience* Experience with FDA and other medical regulatory environments* Knowledge of wireless protocols like ... Bluetooth Low Energy (BLE)* Agile or other software development life cycle concepts**Education and Experience Bachelor's Degree or above in Computer Science or Electrical and Computer Engineering preferred**Additional Information **NOTE**: This position is… more
- Abbott Laboratories (Livermore, CA)
- …Claims Act, Civil Monetary Penalties Law, Stark, Beneficiary Inducement Statutes), FDA regulation (Food, Drug & Cosmetic Act), privacy (HIPAA), and anti-corruption ... (Foreign Corrupt Practices Act);* Representing Abbott externally to suppliers and customers; and* Helping select and/or directing the work of outside counsel, defining project objectives, managing project, and monitoring outside counsel budget.* This position… more
- Danone (White Plains, NY)
- …as an integral part of disease management. Consisting of a wide variety of FDA and Health Canada regulated nutrition products, we are especially active in the ... management of inherited metabolic diseases, severe pediatric allergic and gastrointestinal disorders, pediatric epilepsy, and long term and critical care for seniors. Danone North America is proud to be an Equal Opportunity employer. It is our policy to give… more
- Stratpharma (Hartford, CT)
- …offers a high-commission model and the opportunity to work with a range of FDA -cleared products. Join a growing team and make a difference in patient care today. ... The ideal candidate will have over 2 years of sales experience and strong organizational and communication skills. The position… more
- Biogen, Inc. (San Francisco, CA)
- …principles and clinical trial methodology.. Experience in meeting FDA and international regulatory guidelines.. Knowledge of medical/biological terminology ... and clinical practice in relevant therapeutic areas.. Proven track record of staff development and effective people management.. Strong ability to motivate and ensure productivity under ambiguous conditions.. Leadership skills in proactive strategy setting,… more
- Pharmatech Associates (San Diego, CA)
- …Regulatory Affairs Consultant to lead regulatory strategies and support submissions to the FDA . This remote position requires an advanced degree and over 10 years of ... experience in regulatory affairs, particularly with in-silico and predictive modeling. The ideal candidate will have a proven track record of successful regulatory submissions and the ability to communicate effectively with stakeholders. #J-18808-Ljbffr more
- Topography Health, Inc. (Baltimore, MD)
- …in clinical trials. 3+ years of experience with Good Clinical Practice (GCP), FDA , and ICH guidelines. 3+ years of experience working with electronic document ... management systems. PREFERRED QUALIFICATIONS Certification in clinical research (eg, CCRC, CCRP) is a plus. Located in Ann Arbor, Baltimore, DC, or Denver #J-18808-Ljbffr more
- Gilead Sciences, Inc. (Foster City, CA)
- …that align with the Medical Affairs goals while ensuring compliance with ACCME, FDA , OIG, and other relevant guidelines (as well as Gilead policies and ... federal/state/local statutes and regulations). Staying abreast of industry trends and regulatory changes in the medical education is crucial to inform decision-making and strategic planning. The Senior Director will also be tasked with cultivating and… more
- Pharmatech Associates (Houston, TX)
- …are not limited to: Conducting gap assessments of a company's QMS against US FDA requirements with the aim of helping our clients pass a pre-approval inspection in ... support of ANDA, NDAs, and BLA submissions, and providing prioritized remediation recommendations Evaluation of inspection readiness programs, including providing recommendations for improvement Remediation planning for various dosage form manufacturing… more
- Barry-Wehmiller Companies Inc. (East Brunswick, NJ)
- …This role requires extensive experience in validation and project management within FDA regulated projects. You'll lead a team, develop project scopes, and enhance ... client relationships in a collaborative environment. Ideal candidates should possess strong leadership, technical writing skills, and a Bachelor of Science degree in engineering. The position offers the opportunity for substantial professional growth and… more
