- Teva Pharmaceuticals (West Chester, PA)
- …to make a difference with. **The opportunity** The Senior Manager in Global Regulatory Medical Writing writes and edits clinical regulatory ... Senior Manager , Medical Writing -...documents include the proper content and context (from a regulatory medical writing perspective) and… more
- Teva Pharmaceuticals (West Chester, PA)
- …a difference, and new people to make a difference with. **The opportunity** The Medical Writing Manager in Global Regulatory Medical Writing is ... Manager , Medical Writing (REMOTE)... Manager , Medical Writing (REMOTE) Date: Dec 21,...responsible for writing and editing clinical regulatory documents, providing oversight and guidance, and managing resources… more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Writing Senior Manager ** **Live** **What you will do** Let's do ... following applicable standard operating procedures + With limited supervision, lead regulatory writing activities for complex product submissions, including new… more
- Edwards Lifesciences (Charleston, WV)
- …longer and healthier lives. Join us and be part of our inspiring journey. The Senior Manager , Medical Writing oversees medical writing projects and ... and oversee the work of small medical writing team to support clinical and regulatory ...or equivalent work experience based on Edwards criteria + Medical writing or regulatory certification… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Manager , Regulatory Affairs, is responsible for preparing, filing and gaining ... timely regulatory clearance/approval for marketing. + Develops Regulatory team expertise in project management, writing ,...equivalent. + Minimum of 3 years' experience in a regulatory capacity within the medical device industry,… more
- ThermoFisher Scientific (Morrisville, NC)
- …and in the future. **Summarized Purpose:** We are excited to expand our Medical Writing FSP Team and appoint a Program Manager (FSP Document Review Lead) to ... and DR client-specific leads. We are seeking a Program Manager who will be responsible for implementing document review...ideal candidate will have relevant experience in document review, medical writing or a related field, a… more
- Olympus Corporation of the Americas (Westborough, MA)
- …the Global Senior Manager to plan and direct the OSTA Core Regulatory Affairs Team activities including but not limited to analysis of requirements and resource ... + Strategic Leadership and Portfolio Alignment: + Facilitate development of global regulatory strategies for medical devices and digital health solutions,… more
- ICON Clinical Research (NC)
- Senior Manager , Regulatory Affairs - IVD ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an ... to join us on our mission to shape the future of clinical development. Sr Manager , Regulatory Affairs - IVD Location: US Remote, Portland, OR area preferred We… more
- Abbott (Alameda, CA)
- …for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work on-site at ... their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - APAC** position will...strategies on complex issues + Work closely with in-country regulatory representatives, compile, prepare, and review medical … more
- Abbott (Pleasanton, CA)
- …mothers, female executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager ** to join Abbott's Heart Failure Division on-site ... CA. As an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge...medical fields. + Advanced degree + 8 years' Regulatory experience + Experience working in a broader enterprise/cross-division… more
- Olympus Corporation of the Americas (Westborough, MA)
- …the medical device classification, and connected technologies. + Provide regulatory guidance, compliance risk assessment, and strategic input to digital product ... and maintain standard operating procedures (SOPs), compliance frameworks, and internal regulatory guidance specific to non- medical device digital health… more
- J&J Family of Companies (Titusville, NJ)
- …Johnson & Johnson Innovative Medicine R&D is recruiting for a Manager , Regulatory Scientist. This position is a hybrid role ... NJ; Spring House, PA; or San Diego, CA. The Manager , Regulatory Scientist is a regulatory...leading meetings. + Assist in strategy development by researching regulatory and medical information in preparing submissions… more
- Fiserv (Berkeley Heights, NJ)
- …impact on a global scale, come make a difference at Fiserv. **Job Title** Regulatory Compliance Senior Manager **About your role:** The Senior Compliance ... military experience. **Experience that would be great to have:** + Certified Regulatory Compliance Manager (CRCM) certification. + Paralegal or other legal… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …staff. **Minimum Requirements:** + Bachelor's degree + Minimum 5 years of strong Regulatory Affairs experience in the medical device and/or in vitro diagnostic ... of possible** BD is one of the largest global medical technology companies in the world. Advancing the world...This position will be working in BD-Connected Care on Regulatory Affairs projects that support the Pharmacy Automation business.… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …more than 110 countries and regions. **Summary:** Implement worldwide regulatory product registration strategies, prepare complex registration dossiers, establish ... on labeling, labeling requirements, and implementation. Coordinate and submit all regulatory documentation for establishment of new / changed local market… more
- Dentsply Sirona (Waltham, MA)
- …functions of the Dentsply Sirona Essential Dental Solutions team. This role develops regulatory strategies for existing, new, and modified medical devices and ... implements regulatory strategies to obtain and maintain regulatory approvals for medical devices and other...Strong written and verbal communication skills. + Prior technical writing experience and proven track record with FDA and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …**Job Description** **POSITION OVERVIEW:** You will typically act as the Regional Regulatory Lead on the assigned products, compounds, indications or projects in ... Virology. With guidance, you will define the regulatory strategy, plans and objectives for the assigned products or projects. You will typically lead the … more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing , regulatory operations, etc.) to develop global ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- BeOne Medicines (San Mateo, CA)
- …and/or safety reports (eg, CIOMS). **Essential Functions of the job:** **Narrative Writing ** **:** + Writes, edits, reviews, finalizes, and tracks patient safety ... Clinical Database and Safety Database outputs and ensures their appropriate medical cohesiveness. + Identifies crucial discrepancies between the clinical and safety… more
- University of Utah (Salt Lake City, UT)
- …**Requisition Number** PRN43595B **Job Title** Compliance Officer **Working Title** Regulatory Compliance Manager - Hybrid/Remote **Career Progression Track** ... Incumbent is responsible for assisting the University in preparation for regulatory audits by developing, monitoring and updating quality controls and recommending… more
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