Senior Director, Medical Writing & Regulatory Strategy
Agomab Therapeutics
Agomab Therapeutics is seeking a Senior Director of Medical Writing to lead the regulatory writing function across multiple programs. This strategic role embeds within Regulatory Affairs, partnering with Clinical Development, Biostatistics, and Pharmacovigilance to shape narrative strategy, improve document quality, and ensure submission readiness. The role emphasizes AI-enabled tools, cross-functional collaboration, and an inspections-ready framework to scale as programs advance to Phase 3 and #J-18808-Ljbffr Agomab Therapeutics
$210k - $300k
...OverviewRhythm is seeking a Senior Director, Biostatistics to join our Biostatistics... ...to shape statistical strategy for programs that have the... ...will partner across clinical, regulatory, safety, data management, programming, and medical writing/publications teams to provide...SeniorMedicalRegulatoryInterim roleWork at officeFlexible hoursShift work$252k - $378k
...DescriptionGeneral Summary:The Medical Affairs Senior Director provides medical and... ...that scientific and medical strategies are aligned with broader... ...understanding of global medical, regulatory and commercial (including... ...countriesExperience in writing or reviewing scientific...SeniorMedicalRegulatoryFull timeSummer workLocal areaRemote workFlexible hours2 days per week$166.5k - $264k
...Description Title: Director/Sr Director,... ....We are seeking a senior technical leader to... ...and translational strategy for this platform... ...academic, clinical, and regulatory stakeholders, and... ...research, technical writing, and translational... ...; eligibility for medical, dental, vision...SeniorMedicalRegulatoryFlexible hours- Senior Director, Medical Writing Department: Regulatory Affairs Employment Type: Permanent - Full Time Location: Agomab US Reporting To: Senior VP/Head of... ...embedded across all clinical programs, owning narrative strategy and document quality, managing CRO medical writing...SeniorMedicalRegulatoryPermanent employmentFull timeWork at officeLocal areaRemote workWorldwide
- ...input to development strategies, and effective implementation... ...organization. The Senior Director provides expertise... ..., interpretation and regulatory submission of... ...interpersonal, communication, writing and organizational... ...include: Health Coverage: Medical, pharmacy, dental,...SeniorMedicalRegulatoryHourly payFull timeTemporary workPart timeSummer workLive inLocal areaRemote workFlexible hoursShift work
$177k - $294.8k
...cardiovascular disease.The Senior Director, Trial Management provides... ...including Clinical Development, Regulatory, Data Management, Patient... ...retention, Study start up, Medical Writing, Supply Chain, Quality,... ...resolutionOversee CRO and vendor strategy within the function,...SeniorMedicalRegulatoryFlexible hours$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical... ...in verbal presentations and in writing regulatory strategy plans and submission... ...their growth and aspirations. From medical, dental and vision benefits to...SeniorMedicalRegulatoryFull timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week$115k - $209k
...clinical and commercial strategy, and will lead the... ...lives in the heads of senior strategic and translational... ...) in a life science, medical, or related discipline... ...preclinical, CMC, regulatory, and clinical functions... .... Comfort reading and writing code well enough to prototype...SeniorMedicalRegulatoryCasual work- ...Join to apply for the Senior Director, Biostatistics role at BioSpace 2... ...leading statistics efforts during regulatory submissions, serving as the... ...20,000.00 3 days ago Senior Medical Director, Clinical... ...Writer - Regulatory and Medical Writing Associate Director, Statistical...SeniorMedicalRegulatoryFull timeLocal areaRemote work
- ...Position Summary The Senior Director, Medical Affairs (Strategy) will be a key leader responsible for developing... ...Clinical Development, Commercial, Regulatory, and other cross-functional teams,... ...communication, scientific writing, and stakeholder-management skills...SeniorMedicalRegulatoryFull time
- Position Summary: As the Senior Director of Biostatistics, you will lead and... ...area, ensuring statistical strategies align with clinical development objectives and regulatory standards. In this leadership... ...functional stakeholders.Partner with medical, regulatory, pharmacology,...SeniorMedicalRegulatoryFull time
$235k - $330k
...heard.How you’ll make an impact:The Senior Director, Outcomes, Value & Access will serve... ...value communication, and payer-relevant medical strategy across the pipeline. Reporting to the... ...Market Access, Clinical Development, Regulatory, Commercial, and Global teams.Health...SeniorMedicalRegulatory$263k - $292k
...defined clinical development and regulatory path, and each expected to... ...is seeking an experienced Senior Director, Biometrics to serve as the... ..., dose-escalation strategy, interim analyses, regulatory... ...Operations, Regulatory Affairs, Medical Writing, Translational Medicine and...SeniorMedicalRegulatoryFull timeTemporary workInterim role$252k - $378k
...Job DescriptionGeneral Summary:The Senior Director (non-MD) serves as a US Medical Affairs asset lead responsible... ...functional teams, ensuring medical strategies are aligned with corporate... ...Commercial, Market Access, HEOR, Regulatory, Clinical Development, and Corporate...SeniorMedicalRegulatoryFull timeSummer workRemote workFlexible hoursShift work2 days per week- This is what you will do: The Senior Director, Rare Endocrinology and Rare Tumors (RERT... ...and implementation of the PS strategy for four indications: Hypophosphatasia... ...operations, compliance, IT, legal, regulatory, training, medical, and field leadership). This leader...SeniorMedicalRegulatoryFull timeWork at office
$128.55k - $222.82k
...supervising a working group of Senior Tax Managers and Tax Managers... ...new tax legislation, regulatory guidance, and industry developments... ...implications of new products, fund strategies, and business initiatives.... ....Know Your Rights I Family & Medical Leave I Employee Polygraph...SeniorMedicalRegulatoryFull timeTemporary workLocal area$212k - $333.19k
...DescriptionAbout the role:The Senior Director, Oncology Search &... ...and supporting disease area strategy and early asset commercial planning... ...translating scientific, clinical, regulatory, and competitive insights... ...at major scientific, medical, and partnering forums to identify...SeniorMedicalRegulatoryMinimum wageLocal areaRemote work$240k - $389.4k
...patients.Purpose of the Role:The Senior/Executive Director [commensurate with... ...responsible for the overarching medical strategy and medical oversight for... ...in the preparation of regulatory documents (IND, CTA, IMPD,... ...management plans, protocol writing, regulatory documents, CRO...SeniorMedicalRegulatoryLocal areaRemote workFlexible hours$212.99k - $319.49k
...sponsorship) to make it real. As Senior Director, Multimodal AI & Outcome... ...and AI-enabled diagnostic strategies, identify comorbidities, and... ...frameworks, cross-site robustness, regulatory-grade evidence generation,... ...data science, diagnostics, medical affairs, commercial, and...SeniorMedicalRegulatoryFull timeTemporary workWork at officeRemote workFlexible hours3 days per week$242k - $313k
...fully. Job Summary: The Senior Director, Biostatistics is a senior... ...expert - owning statistical strategy and methodology for assigned... ...a key statistical voice in regulatory interactions and submissions... ..., Translational Medicine, Medical Affairs, and Clinical Pharmacology...SeniorMedicalRegulatoryLocal areaFlexible hours2 days per week$210k - $260k
...wide range of therapeutic editing strategies that Beam is using to advance a diversified... ...in the Beam portfolio. The Director of Pharmacovigilance will contribute... ...Clinical Development, Clinical Science, Regulatory Affairs, Medical Writing, Nonclinical, and Quality....MedicalRegulatoryFull time3 days per week1 day per week- ...data and meeting their regulatory obligations.Accenture... ...as trusted advisors to senior client stakeholders.... ...relevant narratives for director and C-suite audiences.... ...of benefits including medical, dental, vision, life,... ...and assets across Strategy & Consulting, Technology...SeniorMedicalRegulatoryFull timeWork experience placementLive inWork at officeLocal area
$250k - $300k
...commercial product. As the Senior Director, Late-Stage Cell Therapy Process... ..., robustness, quality and regulatory compliance. Lead process... ...and execute a comparability strategy for pivotal process changes.... ...HIV or Hepatitis C infection, medical condition (cancer or a record...SeniorMedicalRegulatory$175.5k - $246k
...access to market leading medical and emotional and... ...SummaryThe Compensation Director is responsible for supporting... ...goals and talent strategies. Monitor market trends... ...audits, and regulatory reporting requirements... ...keyboard, telephone, or writing. The employee is frequently...MedicalRegulatoryTemporary workFor contractorsWork at officeLocal area$212k - $333.19k
...you to shine? Join us as a Senior Director, Pharmacovigilance Process Lead... ...areas, setting the strategy, accountability, and oversight... ...execution, in alignment with regulatory requirements.Cultivates trusted... ...Operations, Clinical Science, Medical Affairs, Commercial, Local...SeniorMedicalRegulatoryMinimum wageTemporary workWork at officeLocal areaRemote work$120k - $200k
The Opportunity:As the Senior Associate/Associate Director of Portfolio and Strategy Operations, you will help ensure flawless operation of activities for a first... ...across key cross-functional team members such as Medical, Clinical Operations, and Pharmaceutical Development...SeniorMedicalFlexible hours$235k - $285k
...Program Management and Portfolio Strategy Job TypeFull-... ...culture thrive. Join us as a Senior Director, CMC Technical Lead , and you... ...teams, external partners, and regulatory authorities to ensure successful... ...health decision-making, medical leave or other types of protected...SeniorMedicalRegulatoryTemporary workLocal area$150k - $225k
...with pharmaceutical companies, academic medical centers, data partners, and patient advocacy... ...Officer, Bruce Church, at the AI Regulatory & International Symposium (AIRIS) .... ...alliance objectives aligned with the corporate strategy. The position requires strong scientific...SeniorMedicalRegulatoryFull timeContract workPart timeWork at officeLocal area- ...statistical issues in regulatory agency meetings. Leading... .... As an Associate Director, responsible for... ...teams. Interact with Medical Directors, Clinical Scientists... ...Management, Medical Writing, and others to design... ...and development strategies. ~ Excellent influence...MedicalRegulatoryFull time
$214k - $290k
...thrive. Join us as a Senior Director, Alliance Management , and... ...product development, quality, regulatory affairs, manufacturing, project... ...execute long-term alliance strategies aligned with Hypercon's... ...biotechnology, pharmaceutical, medical technology, or related industry...SeniorMedicalRegulatoryLocal area
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