Strategic Regulatory & Medical Writing Lead
BioSpace
Nurix Therapeutics in Brisbane, CA, is seeking an Associate Director of Regulatory & Medical Writing to independently author, review, and approve critical regulatory documents from protocols to health authority submissions. You will lead timelines, manage the authoring process, and ensure consistency across assets for multiple programs. The role requires 6–8+ years in Regulatory/Medical Writing, expertise in health authority submissions, and strong cross-functional collaboration. #J-18808-Ljbffr BioSpace
- Structure Therapeutics Inc. is seeking an Associate Director of Medical Writing to lead regulatory and clinical document development, ensure quality and... ..., and more. This role requires meticulous oversight, strategic guidance, and a track record in regulatory writing...MedicalRegulatory
- Nurix Therapeutics is seeking an Associate Director of Regulatory & Medical Writing to independently lead authoring, review, and approval of critical regulatory documents across our pipeline. You will drive strategic messaging, ensure document consistency, and manage the...MedicalRegulatory
$2,000 per month
...us! The opportunity We’re hiring a strategic deals person to own high‑value relationship... ...dynamics, competitive positioning, and regulatory developments affecting Column’s target... ...options to enable use of pre‑tax money for medical and dependent care expenses ~401k plan...MedicalRegulatoryWork at officeRemote workFlexible hours- Enigma Search is looking for an Associate Director, Medical Writing in South San Francisco, California. This role involves leading the development of clinical and regulatory documentation, ensuring compliance with global standards, and managing the writing process. The...MedicalRegulatory
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...OpportunityWSP USA is seeking a Lead Consultant, Ports and... ...(PS&E) submissions.Write technical reports,... ...clients. Interact with regulatory agencies, subcontractors... ...include coverage related to medical, dental, vision,... ...planners, technical experts, strategic advisors and...MedicalRegulatoryFor subcontractorLocal areaFlexible hours- ...Pharmaceuticals is seeking an experienced Regulatory Affairs professional to advance oncology product... ..., compliant submissions. The role requires strategic thinking with strong execution, excellent writing, and the ability to lead cross-functional programs through INDs and...Regulatory
$165.1k - $306.7k
...Sciences (PDD) that provides strategic leadership and scientific rigor... ...exploratory analyses, early regulatory engagements, and complex data... ...that drive high-quality Medical Data Review (MDR) and safety... ...The Real-time Visual Analytics Lead is responsible for driving the...MedicalRegulatoryLocal area- Structure Therapeutics Inc. in California is seeking an Associate Director of Medical Writing to lead the development of regulatory and clinical documents, ensuring compliance with FDA, EMA and ICH guidelines, and maintaining high quality across programs. The role emphasizes...MedicalRegulatory
$142k - $213k
...Quality Systems and Compliance Lead drives quality excellence at... ...domains and leading strategic QA initiatives with measurable... ...health, research tools, and medical devices are developed, commercialized... ...of quality, reliability, and regulatory compliance. Responsibilities...MedicalRegulatoryFull time$146.54k - $189.64k
...whose mission is to achieve regulatory approval and successful marketing... ...is to deliver on unmet medical needs by introducing therapies... ...Statistical Programming (AOSP) Lead is essential to these partnerships... ...communication and writing skills.Superior skills in coaching...MedicalRegulatoryFull timeFor contractorsLocal area- ...R&D team at the Genentech campus in South San Francisco. You will provide strategic legal advice to support R&D functions, including FDA/regulatory, data sharing, clinical operations, and medical affairs, with emphasis on drug, device, digital, and integrated solutions....MedicalRegulatory
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...comResponsibilities include: Provides regulatory leadership in support... ...Clinical Operations, Medical Affairs, CMC, and... ...commitmentsProvides strategic regulatory direction... ..., Orphan Drug, etc.Lead and manage... ...requirementExcellent regulatory writing and review skills with...MedicalRegulatory- ...strategies for gene therapy programs. You will collaborate across Clinical, Regulatory, Commercial, and Medical Affairs to align HEOR activities with regulatory and payer needs. The role requires leading studies, managing vendors, and ensuring rigorous methodological...MedicalRegulatory
$174.7k - $324.5k
...Clinical Quality Compliance and Policy Lead, you will serve as a strategic advisor embedded across Early... ...culture, translating complex global regulatory requirements into pragmatic, robust... ...PharmD, PhD, or JD) in a scientific, medical, or regulatory discipline.Direct...MedicalRegulatoryLocal areaRelocation package3 days per week$55.94 - $62.94 per hour
...drug safety monitoring, and regulatory compliance within a leading biopharmaceutical... ...regulatory requirements. Perform medical and clinical assessments... ...projects and support strategic patient safety initiatives... ...information. Scientific or medical writing experience. Strong...MedicalRegulatoryFull timeContract workMonday to Friday$180k - $212k
...the Vice President of Regulatory Affairs, this position... ...responsible for the technical writing oversight of regional... ...Affairs with strategic regulatory submissions... ...documents, taking a proactive lead role in driving... ...present statistical and medical information to ensure...MedicalRegulatoryLocal areaRemote workFlexible hours- ...Executive Director, Global Medical Affairs Lead, Oncology About the Company Innovative biopharmaceutical company Industry... ...that all activities are in line with the company's strategic objectives and regulatory requirements. This pivotal role demands a leader with...MedicalRegulatoryRemote work
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...Partnerships, strategic partner lead Department: Revenue Location: New York City, San Francisco, Remote - US Compensation: $199K... ...and ESG data, produce audit-ready metrics for voluntary and regulatory reporting including CSRD, and drive real decarbonization. We...RegulatoryFull timeWork at officeRemote workDay shift$216.4k - $234.8k
...authorities and the world. As Associate Director, Regulatory & Medical Writing, you’ll independently lead the authoring, review, and approval of critical regulatory... ...submissions. It’s a chance to bring clarity and strategic messaging to the documents that move our therapies...MedicalRegulatoryOdd jobLocal areaFlexible hoursShift work$163.68k - $282.35k
...-10-27Arcadis is the world's leading company delivering sustainable... ...of technical and strategic leadership, market development... ...address California’s evolving regulatory, climate, and infrastructure... ...positions. These benefits include medical, dental, and vision, EAP, 401...MedicalRegulatoryFull timePart time- ...PV Clinical Scientist leads clinical review of USPS... ...) based on their medical assessment Performs labeling... ...and provide strategic resolution to management... ...and other applicable regulatory guidance documents, global... ...regulations (Required) Writing experience; science/medical...MedicalRegulatoryLocal areaMonday to FridayFlexible hours
$178.26k - $367k
...Law Team at Pinterest provides strategic, practical counsel to the... ...looking for an experienced Senior Lead Counsel with a strong... ..., agency investigations, and regulatory matters; develop practical resolution... ..., childbirth, or related medical conditions), sexual orientation...MedicalRegulatoryWork at officeLocal areaRemote workRelocationRelocation package- ...ApplicationsEmail: ****@*****.*** Medical Officer (Team Lead) | Early Phase Clinical ResearchLocation: BrisbaneA leading... ...management activities, including CAPAs, deviations, audits, and regulatory inspections.Drive continuous improvement initiatives,...MedicalRegulatory
- ...Genentech, a member of the Roche Group, seeks a Senior Strategic Outsourcing Manager to lead nonclinical outsourcing strategy for Translational Safety... ...or CROs, with deep knowledge of drug development, regulatory requirements, and vendor management. Travel may be required...Regulatory
$90 - $98 per hour
...a hybrid schedule. This role leads execution and delivery of early... ...scopes of work. Provide strategic input into the overall study... ...requirements, international regulatory guidelines, and drug development... ...coverage options including medical, dental, vision, spending accounts...MedicalRegulatoryContract workLocal areaFlexible hours$197k - $235k
...that enable people to lead longer and healthier lives... ...catalyze and enable medical breakthroughs.Position... ...Responsibilities: Strategic Leadership Develop and... ...advancements in DMPK science and regulatory guidelinesCollaborate... ...experience in writing regulatory documents is...MedicalRegulatory$200k - $250k
...are seeking an experienced Medical Director to lead Medical content strategy, scientific... ..., Medical Information, Regulatory, Commercial, Legal, and... ...teams and contribute to strategic planning for product launch... ...education. Excellent scientific writing, presentation, and...MedicalRegulatoryRemote work$150k - $200k
...plaintiff law sector through automation of medical chronologies, demand letters, and... ...retrieval. We are dedicated to becoming the leading AI‑driven solution provider for personal... ...for a proactive and relationship‑driven Strategic Partnerships Lead to join our growing team...Medical- ...agentic document platform for leading AI teams who demand... ...Round Capital, and are hiring a Strategic Partnerships Lead to build Reducto... ...Reducto today, and you will write it. You'll identify and prioritize... ...health insurance covering medical, dental, and vision. Health...MedicalWork at office
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