- ThermoFisher Scientific (Greenville, NC)
- …Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** Join us as a Program Manager within our Regulatory Medical Writing team where you ... makes a real difference in organizational performance. As a Regulatory Medical Writing Program Manager ,...serve as backup medical writer. Duties could include researching, writing and editing clinical study reports and… 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
- Integra LifeSciences (Trenton, NJ)
- …+ Medical device experience is preferred (510(k), PMA, BLA, HCTP). + Experience in regulatory writing is preferred. + Skilled in written and oral communications. ... outcomes and set new standards of care. The **Associate Manager , Medical Writing ** is a senior level...clinical deliverables in accordance with internal GSOPs, and regulatory guidelines including clinical sections for … more
- ICON Clinical Research (NC)
- …and we welcome you to join us on our mission to shape the future of clinical development. Sr Manager , Regulatory Affairs - IVD Location: US Remote, Portland, ... Senior Manager , Regulatory Affairs - IVD ICON...affairs, including development of regulatory strategies, document writing , marketing authorization applications, clinical trials, post-licensing… more
- ThermoFisher Scientific (Wilmington, NC)
- …that people and communities depend on - now and in the future. ROLE: Regulatory Intelligence Manager LOCATION: Fully Remote, East Coast is highly preferred ... **Position Summary** The Regulatory Intelligence Manager will play a pivotal...programs and operational practices. + **Stakeholder Alignment:** Interact with Regulatory Affairs, Clinical , Quality, Pharmacovigilance and Legal… more
- Edwards Lifesciences (Charleston, WV)
- …+ Manage and oversee the work of small medical writing team to support clinical and regulatory submissions (eg, clinical study reports, clinical ... and be part of our inspiring journey. The Senior Manager , Medical Writing oversees medical writing...Regulatory Affairs, Biostatistics, R&D, QA and Marketing on clinical data reports and plans throughout product lifecycle +… more
- PCI Pharma Services (Philadelphia, PA)
- …our global network to pioneer and shape the future of PCI. The Clinical Regulatory Affairs Specialist-2 oversees the company's policies and objectives involving ... properly followed and applied by all appropriate personnel. + Assists the Regulatory Affairs Manager by hosting audits, developing appropriate corrective actions… 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... requirements and guidelines, specific to the areas of clinical research, product development, and labeling, is required. +… 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 ... and achieves timely regulatory clearance/approval for marketing. + Develops Regulatory team expertise in project management, writing , testing methods, and… more
- ThermoFisher Scientific (Wilmington, NC)
- **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** **Medical Writing Manager (FSP)** At Thermo Fisher Scientific, you ... announce that we are looking for an FSP Medical Writing Manager in the United States! Are...(advanced degree-PharmD, PhD, MSc-preferred). . 5+ years of relevant regulatory writing experience, including at least 2… more
- Taiho Oncology (Princeton, NJ)
- …Knowledge, Skills, and Abilities: + Minimum of 4 years combined experience in academic/ clinical and/or industry setting writing clinical protocols, CSRs ... in a dynamic, collaborative, and cross functional environment. Position Summary: The Manager , Medical Writing is accountable for the timely delivery of high… 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) Date: Dec...responsible for writing and editing clinical regulatory documents, providing oversight and guidance,… 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...guidelines, policies and regulations + Ethical guidelines of the regulatory profession, clinical research and regulatory… 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Study Management, Clinical , Nonclinical, Biomarkers). + With guidance, defines the regulatory strategy for one or more Gilead products or projects. + Proactively ... **Job Description** **POSITION OVERVIEW:** You will typically act as the Regional Regulatory Lead on the assigned products, compounds, indications or projects in… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing , regulatory operations, etc.) to develop global regulatory plans, ... experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical ...in regulatory affairs or related areas (eg, clinical development, project management, quality assurance, etc.) in pharmaceutical… more
- ThermoFisher Scientific (Morrisville, NC)
- …now 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 ... step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel… more
- Abbott (Maple Grove, MN)
- …colleagues serve people in more than 160 countries. **Job Description Senior Project Manager , Clinical Evaluation** The function of a Clinical Evaluation ... Report Project Manager supporting our Structural Heart Clinical Evaluation Products combines understanding of scientific and research methodology, medical device… more
- Edwards Lifesciences (Portland, OR)
- …understanding of related aspects of clinical science and/or scientific/medical writing . + Expert knowledge of regulatory requirements and study execution. ... + As a key member of the Medical Affairs Clinical Science team, the Senior Manager (formal...the US + Contribute to strategy and planning of clinical science and medical writing deliverables. +… more
- Abbott (Maple Grove, MN)
- …of a device over its lifecycle. The position reports to the Sr. Manager of Clinical Evaluations Global Regulatory Operations. **Main Responsibilities:** ... in more than 160 countries. The function of a Clinical Evaluation Project Manager supporting our Structural...of documents between stakeholders (eg, internal personnel such as Regulatory Affairs, R&D, Clinical R&D, Sales and… more