Job Family : Strategy & Transformation Consulting Travel Required : Up to 10% Clearance Required : Ability to Obtain Public Trust What You Will Do : Is life sciences in your DNA? Breakthroughs in pharma are helping people live longer, healthier lives while bringing hope to patients with rare diseases. With outpaced growth across the industry and advancements in drug development this is undoubtedly a transformative time for regulators, developers, and patients. Guidehouse's Regulatory Life Scien
Job Family : Strategy & Transformation Consulting Travel Required : Up to 10% Clearance Required : Ability to Obtain Public Trust What You Will Do : Is life sciences in your DNA? Breakthroughs in pharma are helping people live longer, healthier lives while bringing hope to patients with rare diseases. With outpaced growth across the industry and advancements in drug development this is undoubtedly a transformative time for regulators, developers, and patients. Guidehouse's Regulatory Life Scien
Job Family : Strategy & Transformation Consulting Travel Required : Up to 10% Clearance Required : Ability to Obtain Public Trust What You Will Do : Is life sciences in your DNA? Breakthroughs in pharma are helping people live longer, healthier lives while bringing hope to patients with rare diseases. With outpaced growth across the industry and advancements in drug development this is undoubtedly a transformative time for regulators, developers, and patients. Guidehouse's Regulatory Life Scien
Job Title : CMC Regulatory Affairs Manager Location : Remote Duration : 12 Months Responsibilities: Leading project teams, ensuring maintenance of team records and process-related documentation i.e., process maps, job aids, project trackers, checklists, etc.Responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance and defined regulatory strategies along with the preparation and review of information required for
Job Title: Senior Regulatory Affairs Specialist (Medical Devices) Location: Remote Duration: Long term contract Job Description: -Subject Matter Expert for Class II and Class 510(K) submission. -Hands on experience with 510(k) authoring, submissions, and communicating with the FDA. -Hands on experience with software as a Medical Device (SaMD) and validation requirements and applicable consensus standards. Key Responsibilities- -Authoring US FDA 510(k) submission using eSTAR submission tool.
Please note that this is a 1 year contract position. HIGHLIGHTED SKILLS: - Role can be 100% REMOTE - May travel for a possible mandatory meeting onsite (Raritan, NJ) for 1-2 days, not very often at all - Bachelors Degree required - Pharmacovigilance experience needed - Must be flexible / adaptive - Must be able to problem solve, and know when to ask for help - Working within the Global Environment / Global Teams - Regulatory Affairs experience - MAIN ASPECT OF ROLE: Support Aggregate Tracking p
Technical Writer Location: Remote work Duration: 7 months Job description: We are seeking a Technical Writer to join our team and support the IT Operations project tracks within the ISO initiative. In this role, you will collaborate closely with the IT Ops project management team to conduct working sessions and engage with external stakeholders across various ISO tracks. The immediate focus of this position is to work collaboratively with the Infrastructure and Technology, IT Business Engagement
