Senior Medical Writing & Regulatory Lead, Cell Therapies
Viking Therapeutics, Inc.
Artiva Biotherapeutics is seeking a Sr. Manager, Medical Writing to lead clinical and regulatory documentation across development programs. You will author and edit protocols, CSRs, IBs, and regulatory submissions, ensuring accuracy, consistency, and regulatory compliance. Reporting to the Associate Director, Medical Writing, you will collaborate with Clinical Development, Regulatory Affairs, and Biometrics to deliver high-quality documents on tight timelines while upholding scientific rigor and #J-18808-Ljbffr Viking Therapeutics, Inc.
$258.68k - $313.46k
...latest breakthroughs in cell therapy, this is work that... ...us.Sr Director, Global Regulatory Strategy, NeuroscienceWill... ...as Global Regulatory Lead and US Regional... ...include:Health Coverage: Medical, pharmacy, dental, and... ...with Ripley.R1603594 : Senior Director, Global Regulatory...SeniorMedicalRegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- Jobtailor in San Diego seeks a Senior Medical Writer with oncology focus to provide strategic and operational medical writing for complex clinical and regulatory documents. You will lead authoring and end-to-end development for health authority submissions. Requirements...SeniorMedicalRegulatory
- MMS is a global CRO focused on data-driven regulatory writing for pharmaceutical clients. The Medical Writer will evaluate literature, draft protocols, study reports, consent forms, and safety summaries, ensuring scientific rigor and regulatory compliance. With 3+ years...SeniorMedicalRegulatory
$157.55k - $190.91k
...breakthroughs in cell therapy, this is work that... ...understanding of the regulatory and technological... ...& Insider Risk Senior Specialist will be... ...escalate accordingly.Lead periodic... ...(and other local writing systems) and English... ...:Health Coverage: Medical, pharmacy, dental,...SeniorMedicalRegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$165k - $180k
...developing natural killer (NK) cell-based therapies. Our mission is to develop... ...a community setting. Our lead product candidate, AlloNK,... ...Job Summary:The Sr. Manager, Medical Writing plays a key role in supporting clinical development, regulatory submissions, and scientific...SeniorMedicalRegulatoryRemote workFlexible hours$132k - $172k
Department:107200 Medical AffairsLocation:San... ...life-changing therapies to people living with... ...vision of becoming a leading biopharmaceutical... ...Summary:The Senior Manager, Medical Affairs... ...Development, Regulatory, Legal, Compliance... ...evaluation, medical writing, and development of...SeniorMedicalRegulatoryFull timeTemporary workFor contractorsWork at officeRemote work- ...developing natural killer (NK) cell-based therapies. Our mission is to develop... ...in a community setting. Our lead product candidate, AlloNK,... ...activities.Support audits by regulatory or state agencies and partners... ...benefits, including:Medical, Dental, and VisionGroup Life...SeniorMedicalRegulatoryFlexible hours
- Meet Life Sciences in San Diego seeks a Senior Director, Clinical Operations to lead the operational strategy for a first-in-human cell therapy program in autoimmune disease. The... ...collaborating with Clinical Development, Regulatory Affairs, and Quality to advance the...SeniorRegulatory
$185k - $210k
...of delivery, Arrowhead therapies trigger the RNA... ...mechanism present in living cells that inhibits the expression... .... Arrowhead is leading the field in bringing... ...need. The Position The Senior Medical Scientist, Drug Safety... ..., Data Management and regulatory colleagues in the set-...SeniorMedicalRegulatory$265k - $280k
...natural killer (NK) cell-based therapies. Our mission is to develop... ...setting. Our lead product candidate, AlloNK... ...visit .Job Summary:The Senior Director, Safety and... ...with global regulatory requirements and internal... ...with Clinical Leads and Medical Monitors for medical...SeniorMedicalRegulatoryFlexible hours- ...Biotherapeutics in the United States seeks a senior scientific leader to direct the cell potency analytical development... ...assay strategies for NK cell therapies and product characterization. You... ...development, qualification, and regulatory submissions while mentoring a team...SeniorRegulatory
$227.42k - $275.58k
...expertise and resources of a leading innovator in oncology.... ...radiopharmaceutical therapies that offer new hope... ...Pharmacology, Regulatory, and CMC teams.Ensure... ...robust biochemical and cell-based target engagement... ...include:Health Coverage: Medical, pharmacy, dental, and...MedicalRegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaImmediate startRemote workFlexible hours$205k - $268k
...developing natural killer (NK) cell-based therapies. Our mission is to... ...a community setting. Our lead product candidate, AlloNK... ...Job Summary:The Director / Senior Director of Regulatory Operations is responsible... ...benefits, including:Medical, Dental, and VisionGroup...SeniorMedicalRegulatoryRemote workFlexible hours$100k - $118k
...transformative cell and exosome-based therapies for rare diseases... ...(CAP-1002), our lead cell therapy in... ...efficiency, quality, and regulatory adherence.... ...reporting to senior management.· Proficiency... ...report writing, and presenting... ...passion for advancing medical science and...MedicalRegulatoryFull time- Artiva is seeking a senior leader to head the cell potency analytical development team in San Diego. You will define strategy... ...D and Process Development to advance NK cell therapies. You will mentor scientists, author regulatory sections, and oversee method transfers to QC....Regulatory
- Dexcom is seeking a Senior Regulatory Affairs Specialist in a flexible, home-office... ...the San Diego area. You will lead regulatory activities for US,... ...in regulatory affairs for medical devices, with ISO 13485/14971 knowledge and strong writing skills. Travel is minimal; Dexcom...SeniorRegulatoryHome officeFlexible hours
$174.46k - $261.68k
Senior Medical Science Liaison - Cell Therapy (Southern California)Do you have expertise in, and passion for Medical Affairs in Cell Therapy? Are you ready... ...of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the...SeniorMedicalFull timeTemporary workLocal area$130k - $150k
...of highly innovative cell therapies from early clinical development through regulatory approval. As a key scientific... ..., Regulatory Affairs, Medical Writing, and Biometrics, to... ...information for Senior Management. Assist... ...Ability to work with, lead, and motivate a cross-...MedicalRegulatoryFull time- About this role:Wells Fargo is seeking a Senior Lead Private Wealth Portfolio Manager to... ...objectives.Maintain compliance with applicable regulatory, risk, and fiduciary requirements.... ...with DisabilitiesTo request a medical accommodation during the application or...SeniorMedicalRegulatoryFull timeWork experience placementWork at office
$245k - $260k
...Job Description The Senior Director of Clinical... ...focusing on innovative T-cell engager therapies for immunology and... ...Proven track record of leading complex clinical... ...and global clinical regulatory guidelines. Strong... ...families, which includes medical, dental, vision, and...SeniorMedicalRegulatoryHourly payFull timeSummer workRemote workRelocation packageMonday to Friday- ...responsible for building and leading a high-performing sales... ...of the company's first CAR T-cell therapy. They will develop and execute... ...functionally with Marketing, Medical Affairs, Market Access, Business... ...compliance with all regulatory requirements.Essential Responsibilities...MedicalRegulatoryFull time
$245k - $420k
...Ashurst Perkins Coie LLP is a leading international law firm and... ...and market participation.FERC regulatory: represent clients in high-stakes... ..., law school transcript and writing sample.This position is... ...discretionary bonus, 401(k) plan, medical, dental, and vision insurance...SeniorMedicalRegulatoryFull timeWork at office$240k - $270k
...developing engineered Tr1 cell therapies to restore immune... ...Position Summary The Senior Director, Quality (SD)... ...with applicable regulatory requirements. The SD is... ...This position develops, leads, and coaches the teams... ...families) that include medical, dental, vision, long-...SeniorMedicalRegulatoryTemporary workWork at office$155k - $190k
...natural killer (NK) cell-based therapies. Our mission is to develop... ...setting. Our lead product candidate, AlloNK... ...timing or downstream regulatory and clinical supply... ...CMC project lead and senior stakeholders Maintain... ..., including: ~ Medical, Dental, and Vision...SeniorMedicalRegulatoryFlexible hours$96k - $110k
...natural killer (NK) cell-based therapies for patients suffering... ...and cancers. Artiva’s lead program, AlloNK®, is... ...skilled and motivated Senior Quality Control... ...internal, external, and regulatory audits (FDA, EMA, etc... ...thinking and technical writing skills. Computer skills...SeniorRegulatoryContract workWorldwide- ...Bioscience Inc. is a leading developer and manufacturer... ...bromodomains, CAR-T therapy, cell signaling pathways,... ...seeking an exceptional senior scientist with a strong... ...ISO 9001:2015, GLP, and regulatory requirements relevant... ...k with company match Medical/Dental/Vision health...SeniorRegulatory
$252.64k - $306.14k
...latest breakthroughs in cell therapy, this is work that... ...leader to serve as the Senior Director for Clinical... ...reporting automation, regulatory evidence generation, and... ...experience implementing or leading CPP applications, PBPK... ...:Health Coverage: Medical, pharmacy, dental, and...SeniorMedicalRegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$246.98k - $299.29k
...latest breakthroughs in cell therapy, this is work that... ...direction based on global regulatory guidelines and... ...submissions from CMC Leads for clarity of both strategic... ...format to regulatory senior leadership team and other... ...:Health Coverage: Medical, pharmacy, dental, and...MedicalRegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- MMS Holdings Inc in San Diego, CA is seeking a Medical Writer to critically evaluate literature, draft and edit regulatory documents, and lead writing projects with rigorous timelines. You will interact with clients, mentor teammates, and ensure regulatory standards and...SeniorMedicalRegulatory
$96k - $110k
A leading biotechnology company is seeking a Senior Quality Control Associate to support raw materials testing and ensure compliance with regulatory standards. The role involves performing GMP testing, reviewing results, and managing documentation. Candidates should possess...SeniorRegulatory
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