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$210k - $300k
...Overview Rhythm is seeking a Senior Director, Biostatistics to join our... ...opportunity to shape statistical strategy for programs that have the... ...partner across clinical, regulatory, safety, data management, programming, and medical writing/publications teams to provide...SeniorMedicalRegulatoryFull timeInterim 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$286.9k
...DescriptionSenior Principal Scientist (Senior Medical Director) Translational Medicine,... ...closely with scientific, regulatory, statistical, and modeling... ...of biomarker strategies through cross-functional teams... ...preferred.Strong interpersonal, writing and presentation skills, as...SeniorMedicalRegulatoryFull timeFor contractorsLocal areaWorldwideFlexible hours- ...Senior Director, Medical Writing Department: Regulatory Affairs Employment Type: Permanent - Full Time Location: Agomab US Reporting To: Senior... ...embedded across all clinical programs, owning narrative strategy and document quality, managing CRO medical writing...SeniorMedicalRegulatoryPermanent employmentFull timeWork at officeLocal areaRemote workWorldwide
$194.1k - $305.6k
...comprehensive pipeline strategy, partnering across our... ...engagement with regulatory agencies. - ~ Lead... ..., hands-on experience writing IND modules and filings... ...Experience managing a group of senior and junior scientists... ...benefits include medical, dental, vision healthcare...SeniorMedicalRegulatoryFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- ## Sr. Director, BiostatisticsApplylocations:... ...areas of high unmet medical need through... ...Description:****Job Title:**Senior Director,... ...stakeholders, including regulatory agencies and... ...affairs, medical writing, clinical operations... ...product and/or business strategy.* Lead and...SeniorMedicalRegulatory
$275k - $300k
Senior Director, Toxicology (CNS Specialist) Centessa Pharmaceuticals... ...‑level toxicology strategy from target selection... ...to global regulatory submissions. Key Responsibilities... ...and scientific writing skills as applied to... ..., company‑sponsored medical, dental, vision, and...SeniorMedicalRegulatoryFull time$165k - $195k
...software as prescription medical treatments for people... ...the Role: The Director / Senior Director, Science plays... ..., and commercial strategy. This person will act... ...record who is eager to write, speak, and publish externally... ..., clinical, and regulatory teams to ensure that...SeniorMedicalRegulatoryPermanent employmentTemporary workWork at officeLocal areaRemote workVisa sponsorshipFlexible hours- ...Agomab Therapeutics seeks a Senior Director of Medical Writing to anchor our hybrid medical writing model across all programs, owning narrative strategy and document quality. You will balance AI-enabled tools with regulatory rigor, partnering with Regulatory Affairs,...SeniorMedicalRegulatoryRemote work
$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$177k - $308k
...committed to using its innovation-based strategy to discover, develop and deliver innovative... ...while ensuring scientific rigor, regulatory defensibility, and meaningful value creation... ...pension; vacation benefits; eligibility for medical, dental, vision and prescription drug...SeniorMedicalRegulatoryFull timeFlexible hours$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- ...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
$219.4k - $274.3k
...autoimmune diseases. Our core business strategy combines our experienced leadership... ...! Position Summary: The Senior Director, Medical Writing (MW) will be responsible for writing... ...in accordance with program goals and regulatory requirements. We seek a highly qualified...SeniorMedicalRegulatoryContract workFor contractorsWork at office- 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
- Join to apply for the Senior Director, Biostatistics role at BioSpace 22... ...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
$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$162.77k - $207.54k
...About Tufts Medicine Tufts Medical Center Tufts Medical Center,... ...operational, clinical, financial, and regulatory leadership of pharmacy... ...This position serves as the senior pharmacy leader for Tufts Medical... ...of local and system pharmacy strategies. Working collaboratively...SeniorMedicalRegulatoryFull timeTemporary workLocal area$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
$252k - $378k
...Vertex Pharmaceuticals is seeking a Senior Director for US Medical Affairs in Boston to manage medical strategies for nephrology assets. This role requires a terminal... ...healthcare leaders, and ensuring compliance with regulatory standards. The position offers a range of...SeniorMedicalRegulatory$210.9k - $379.2k
...patients' lives worldwide.Moderna is seeking a Global Medical Director to lead medical affairs strategy across our Oncology portfolio, spanning early... ...worldwide. The role will interface extensively with regulatory, clinical, commercial, and external stakeholders to...SeniorMedicalRegulatoryPermanent employmentFull timeWork at officeWork from homeWorldwide$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 - $327.49k
...to make it real. As Senior Director, Multimodal AI & Outcome Prediction... ...and AI-enabled diagnostic strategies, identify comorbidities, and... ..., cross-site robustness, regulatory-grade evidence generation,... ...data science, diagnostics, medical affairs, commercial, and market...SeniorMedicalRegulatoryFull timeTemporary workWork at officeRemote workFlexible hours3 days per week$183.75k - $336.88k
...Position Summary: As the Senior Director, Early Phase CMC Medicine Research... ..., attrition-reduction strategies, and upper-quartile performance... ...chain, quality and CMC regulatory strategy through leadership... ...paid caregiver/parental and medical leave. If salary ranges are...SeniorMedicalRegulatoryFull timeLocal area$230.9k - $384.8k
...’s digital and ‘data first’ strategy focuses on implementing impactful... ...innovation at Pfizer.The Senior Director, Targets and Mechanisms... ...alignment with business objectives, regulatory, and compliance requirements... ...paid caregiver/parental and medical leave, and health benefits...SeniorMedicalRegulatoryPermanent employmentFull timeH1bLocal areaVisa sponsorshipWork visaRelocation packageWeekend work$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
- ...Position Overview The Senior Director, Patient Advocacy & Engagement... ...and lead Egetis’ US advocacy strategy for its MCT8 deficiency program... ...will work closely with Medical Affairs, Commercial, Market... ...strategies. Deep knowledge of regulatory, compliance, and ethical...SeniorMedicalRegulatory
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Director, Medical Writing & Regulatory Strategy. Be the first to apply!
- regulatory affairs manager pharmaceutical Cambridge, MA
- quality regulatory manager Cambridge, MA
- compliance director Cambridge, MA
- director quality compliance Cambridge, MA
- regulatory affairs director Cambridge, MA
- associate director compliance Cambridge, MA
- corporate compliance manager Cambridge, MA
- manager regulatory affairs Cambridge, MA
- regulatory manager Cambridge, MA
- sr. manager regulatory compliance Cambridge, MA


