Fda Regulations Jobs in Griffith, IN

Responsibilities: Lead the validation team in a strategic riskbased approach that optimizes legacy Computer System documentation CSA strategies and strong SAP ECC>S/4 HANAconversion knowledge to successfully deliver a validated system meeting all project requirements. Review approva More...

*Employee can work remotely anywhere in the U.S.  The Principal Medical Writer is responsible for providing writing support and advanced scientific writing expertise to the teams ensuring successful preparation of high quality documents and effective implementation of the wr More...

*Employee can work remotely anywhere in the U.S. The Senior Medical Writer is responsible for providing medical writing ensuring successful preparation of high quality documents and effective implementation of the writing process. Provides medical writing expertise for multiple c More...

*Employee can work remotely anywhere in the U.S. The Senior Medical Writer is responsible for providing medical writing ensuring successful preparation of high quality documents and effective implementation of the writing process. Provides medical writing expertise for multiple c More...

*Employee can work remotely anywhere in the U.S.  The Principal Medical Writer is responsible for providing writing support and advanced scientific writing expertise to the teams ensuring successful preparation of high quality documents and effective implementation of the wr More...

About This Role The Associate Director Quality Assurance & Governance R&D Quality & Compliance (RDQC) will provide strategic guidance oversight and support for the quality activities within the Quality Management System (QMS) including regulatory health inspections and th More...

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems ensuring they are designed validated operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation More...

As a leading pharmaceutical company AbbVie is constantly striving to discover and deliver innovative medicines and solutions that address complex health issues and enhance peoples lives. Bringing a new drug to patients is a complex process that involves not only scientific research an More...

Responsibilities: Lead validation planning risk assessment and for R Studio GitLab and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.. User Requirements Specifications (URS.. Risk Assessments (RA.. Functional and Design Specification More...

Prysmian is the world leader in the energy and telecom cable systems industry. Each year the company manufactures thousands of miles of underground and submarine cables and systems for power transmission and distribution as well as medium low voltage cables for the construction and in More...

General SummaryUnder limited supervision is responsible for the collection of the account balances from all third party payors and patients for services rendered at UMMC Kernan and Specialty Hospital. Manages the Cash Posting area and Followup. Develops and maintains the policies and More...

Reporting to the Manager of Technical Services this position is responsible for conducting the mixing and testing of experimental polymeric compound formulation. This work is conducted under the direction of Polymer Engineers and industry/customer specifications and internal procedure More...

Working with UsChallenging. Meaningful. Lifechanging. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the lat More...

The Policy and Regulatory Affairs team at Zoox is a crossfunctional organization responsible for advancing Zooxs public policy and regulatory goals including working with federal agencies such as the US Department of Transportation (USDOT) National Highway Traffic Safety Administratio More...

What Does a Medical Strategist/Writer DoAt Eversana Intouch Medical Strategists/Writers work as part of a multidisciplinary team to produce slide decks white papers scientific platforms infographics and other materials requiring scientific expertise and strategic communication skills. More...

About the Role:We are seeking a highly experienced and visionary Senior Manager for our AI Foundation team. This role is pivotal in driving the strategy development and implementation of AI capabilities services and solutions to assist our organizations AI initiatives that is a mix of More...

Part of Amgens R&D Strategy & Operations organization the R&D Knowledge & Learning team serves staff across R&D and the Office of the Chief Medical Officer transforming how we learn and grow together. We are reimagining learning as an integrated longitudinal journe More...

The Senior Director of Global Total Rewards is responsible for designing implementing and managing Blends compensation and benefits programs which includes salary bonuses benefits 401k and equity. The individual in this role will work closely with senior leadership the Talent team and More...

What Does a Medical Strategist/Writer DoAt Eversana Intouch Medical Strategists/Writers work as part of a multidisciplinary team to produce slide decks white papers scientific platforms infographics and other materials requiring scientific expertise and strategic communication skills. More...

What Does the Director Medical Strategy DoConsult with Creative Account and Planning teams to develop compelling medical content across all digital and print media Identify new medical advances and opportunities and implement disease state knowledge to drive promot More...