Counsel - Clinical Development, Medical & Regulatory Affairs - Plainsboro, NJ

RK Pharma Inc is seeking a Regulatory Associate to work with our growing Regulatory Affairs Team as we scale towards commercial manufacturing in the next upcoming months. · ...

This is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally. · Maintains therapeutic area and product knowledge through ongoing assessment of relevant ...

This Health Economics & Outcomes Research (HEOR) Consultant position will be responsible for all statistical aspects of research conducted by the HEOR function. · ...

Joining us is a chance to do important work that creates change and shapes the future of healthcare. · Thinking differently is what we do best. To us, change equals opportunity. · Every day our colleagues are challenging what's possible and making headway to innovate new treatmen ...

Changing lives. Building Careers. · To us, change equals opportunity. · ...

Ensures a controlled documentation system record retention and information services including electronic records retention processes in accordance with regulatory requirements. · Maintains the technical and non-technical documentation change system · Interprets and enforces all d ...

We believe everyone has an opportunity to lead. We see the importance of your perspective and your ability to create value. · We want you to fit in with an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to s ...

Ensures a controlled documentation system record retention and information services including electronic records retention processes in accordance with regulatory requirements. · ...

+The manager will have direct responsibility for reviewing worldwide cases in accordance with our policies to ensure quality measures are achieved. · The manager will also be involved in vendor management quality activities. · +Ensures Medical Information case generated within ou ...

The Manager of Medical Quality Assurance and Compliance will play an important role in the day-to-day engagement quality. · Ensures Medical Information case generated within our markets are reviewed and measured against our quality standards and reported in a timely fashion in ac ...

The Regulatory Affairs Operations Specialist is responsible for supporting Sandoz's regulatory operations with a strong focus on regulatory submissions and publishing activities. · This position supports registration data management, · product life cycle activities, · business pr ...

Clinical Trial Lead will be responsible for driving the development and execution of deliverables for assigned Medical Affairs Sponsored Trials (MAST) · Ensure high quality and timely execution of key deliverables and maintain data integrity · Accountable for ensuring scientific ...

The Client Medical organization strives to be recognized throughout the world as the most accomplished and respected BioPharma Medical organization. · In Client Medical, you will have the ability to impact the lives of patients by developing and ensuring the safe and appropriate ...

We believe in providing staffing solutions to address the current talent gap Right Talent Right Time Right Place Right Price and acting as a Career Coach to our consultants. · The IME Manager will work under the direction of an IME Lead and have the following responsibilities: · ...

We are looking for an Independent Medical Education Manager to join our team at Net2Source Inc. The IME Manager will work under the direction of an IME Lead and have various responsibilities including reviewing medical education grant submissions, ensuring compliance and quality ...

This position has the primary responsibility to support the US AML & MF Lead and contribute to Medical Affairs strategy execution including medical training, · advisory boards, medical content development, individual KOL meetings, US congresses, · and other medical led deliverabl ...

The Regulatory Operations Associate is responsible for publishing, QC, and transmittal of eCTD submissions, · as well as document formatting and report-level publishing. · ...

+The candidate would be expected to have a good understanding of the Health Authority query process and the submission translation process to help us support new releases of our systems. · +Product Manager for regulatory submission process · Health Authority query process · ...

The Regulatory Operations Associate is responsible for publishing, QC, and transmittal of eCTD submissions, · e.g., using Acadia's eCTD publishing (IQVIA RIM Smart) and document management (Veeva Vault RIM), publish eCTD submissions and reports in alignment with health authority ...

+Job summary · Sandoz is a global leader in Generic and Biosimilar medicines. The company has over 900 million patient treatments across 100+ countries. · +ResponsibilitiesEngages with cross-functional teams and independently manages deliverables. · Facilitates discussions to exp ...

The Senior Specialist, Regulatory Affairs will provide expertise to the organization in the development of regulatory compliance strategies and in ensuring its conformance to Health Authority requirements. · ...