Regulatory Documents Jobs in USA

Career CategoryScientificJob DescriptionJoin Amgens Mission of Serving PatientsAt Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.Since 1980 weve helped pioneer the world of biotech in o...

Sumitomo Pharma Co. Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America Inc.) Canada (Sumitomo Pharma Canada Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology urology womens health rare dise...

We are seeking a detail-oriented and highly organized Nonclinical Regulatory Documentation Specialist to support quality control and submission readiness of nonclinical regulatory documents. This role will contribute to DMPK and Toxicology reporting regulatory submission modules and document lifecyc...

Job DescriptionContact: Alexandra Spink - No 3rd party candidatesOur client is seeking a Medical Writing Editor to support quality control (QC) review copyediting and submission readiness for clinical and regulatory documents. This role partners with Medical Writers and cross-functional teams to ens...

OverviewThis role will lead in the preparation and submission of electronic regulatory documents through the FDA EMA MHRA and Health Canada Electronic Submission Gateways (ESG) as well as prepare and file non-eCTD submissions to ensure compliance with applicable laws and regulations. The scope of th...

DescriptionThe Senior Medical Writer is responsible for developing writing and managing high-quality clinical and regulatory documents that support compliance and product lifecycle needs for global standards such as EU MDR and FDA regulations. This includes planning implementing and reporting clinic...

Job Description Summary#LI-Hybrid Internal Title: Associate Director/Senior Principal ScientistLocation: San Diego CAWe are seeking an enthusiastic and motivated PK Sciences project team representative to develop and implement translational or clinical pharmacology strategies to support the pursuit...

Job DescriptionGeneral Summary: We are seeking an accomplished and strategic leader to serve as Executive Director Biotherapeutics DMPK-Bioanalysis (DMPK-BA) to guide the DMPK-BA strategy for our rapidly growing Biotherapeutics portfolio that includes protein antibody ADC and cell and genetic therap...

Were here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we...

Overview:Job Description Summary:Assists with the administrative components required to ensure compliance in the regulatory processes for a clinical research project.Job Description:Essential Functions:Creates the initial study administrative binder required for the clinical research project. Mainta...

Job Description:This remote position can be located in South Dakota Minnesota Iowa Nebraska Missouri Texas Wisconsin Michigan Illinois.This person helps manage the day-to-day technical aspects of the established compliance program including administration of the compliance training program and super...

IQVIAs Country Site Activation teamare aglobal network whoidentifyandactivate sites to thehighestquality toensurepatients on Clinical trials have access to safe and effective medication.We are leaders in innovation and first tonew technologiesmeaning a vast amount of career development opportunities...

Welcome to Verdantas where innovation meets sustainability and your career finds purpose!At Verdantas were redefining environmental consulting and sustainable engineering through our use of cutting-edge modeling and digital technology and our genuine commitment to people. Our work spans high-growth...

Global Clinical Development Medical DirectorHybrid Working: 3 days per week in the officeLocation: Gaithersburg MDAre you a clinical research physician ready for new opportunities Would you like to play a pivotal role in the development of potential medicines If you are passionate about being a medi...

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are unique...

Medical Director Clinical Development NeurologyThe Medical Director Clinical Development may lead the clinical sub-team or support the clinical sub-team and the global program team to build global clinical development plans and contributes to the development of asset level and therapeutic area strat...

Overview:Job Description Summary:Develops onboards coordinates and manages clinical trial study and research objectives. Meets requirements follows regulatory guidelines and observes standard operating procedures. Coordinates and executes activities with ongoing study development and process improve...

DescriptionAs an EEO/Affirmative Action Employer all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability or veteran status. Waste Management (WM) a Fortune 250 company is the leadin...

Department OverviewThe mission of the Knight Clinical Research Management organization is to support the conduct of translational clinical research aimed at improving the lives of people and families with cancer by applying innovative strategies for cancer prevention screening diagnosis and treatmen...

About Care AccessCare Access is working to make the future of health better for all.With hundreds of research locations mobile clinics and clinicians across the globe we bring world-class research and health services directly to communities that often face barriers to care.We are dedicated to ensuri...