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
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Senior Director, Medical Writing & Regulatory Strategy in Cambridge, MA vacancy
$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$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 workMerck & Co.
Boston, MA13 days ago- 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
- ## 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
$286.9k
...Senior Principal Scientist (Senior Medical Director) Translational Medicine, Immunology Translational... ...with scientific, regulatory, statistical, and modeling... .... Develop biomarker strategies through cross‑... ...Strong interpersonal, writing and presentation skills...SeniorMedicalRegulatoryFor contractorsWork at officeRemote workWorldwideMonday to FridayMonday to ThursdayShift work3 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 hoursInformation Technology Senior Management Forum
Boston, MA11 days ago$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- Responsibilities Drive market access launch strategy as well as development and... ...-through resources) Own the regulatory and legal approval (... ..., Patient Marketing, Medical, Advocacy, Global and U.S. Franchise... ...clearly, orally and in writing, across internal and external...MedicalRegulatory
$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
BioSpace, Inc.
Cambridge, MA3 days ago - Senior Director, Medical Affairs (Strategy) will be a key leader responsible for developing and executing the Medical... ...Clinical Development, Commercial, Regulatory, and other cross‑functional teams,... ...communication, scientific writing, and stakeholder‑management skills...SeniorMedicalRegulatory
- 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
$275k - $300k
...Centessa is seeking a Senior Director, Toxicology to... ...program-level toxicology strategy from target selection... ...contributions to global regulatory submissions. Key... ...and scientific writing skills as applied to... ...plan, company-sponsored medical, dental, vision, and...SeniorMedicalRegulatoryFull timeRemote work$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$210.9k - $379.2k
...Role Overview The Global Medical Director at Moderna leads medical affairs strategy across the oncology portfolio, spanning from early development to commercialization... ...cross‑functional forums, aligning development, regulatory, and commercial functions. Lead the Development...SeniorMedicalRegulatoryWorldwideModerna Therapeutics
Cambridge, MA1 day ago$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
$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$252k - $378k
## Senior Director, US Medical Affairs – NephrologyApplylocations: Boston, MAtime type: Full timeposted... ...-functional teams, ensuring medical strategies are aligned with corporate... ...with Commercial, Market Access, HEOR, Regulatory, Clinical Development, and Corporate...SeniorMedicalRegulatorySummer workRemote workFlexible hoursShift work2 days per weekVertex Pharmaceuticals
Boston, MA4 days ago$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$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$263k - $328k
...Could you be our next Senior Director Search & Evaluation Late TA... ...TALT, influencing therapeutic strategy and integrating late-stage external... ...with TA strategy and unmet medical needs. Co-lead internal... ..., coordinating clinical, regulatory, commercial, and market access...SeniorMedicalRegulatoryFull timeWork at officeWorldwide3 days per weekCSL
Revere, MA1 day ago$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 areaAitia
Cambridge, MAmore than 2 months ago$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 weekBeeline Medicines
Boston, MA3 days ago$230.72k - $345k
...Job Summary The Senior Director, Biostatistics, provides leadership, oversight... ...development planning, statistical analysis strategy, modeling and simulation, regulatory submission support, advisory... ...Company benefits: Comprehensive medical, dental, vision, prescription...SeniorMedicalRegulatoryTemporary workLocal areaFlexible hoursOtsuka America Pharmaceutical Inc.
Boston, MA3 days ago$215k - $270k
...treatments Job Description The Senior Director, Launch Excellence will provide... ...alignment across Commercial, Medical Affairs, Market Access, Regulatory Affairs, Supply Chain, and other... ...Key Responsibilities: Launch Strategy & Execution Define and lead the...SeniorMedicalRegulatoryTemporary workSobi
Boston, MA25 days ago$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
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Director, Medical Writing & Regulatory Strategy. Be the first to apply!
Related searches
- director global regulatory affairs Cambridge, MA
- regulatory affairs manager pharmaceutical Cambridge, MA
- regulatory manager Cambridge, MA
- manager regulatory affairs Cambridge, MA
- regulatory & compliance manager Cambridge, MA
- head compliance Cambridge, MA
- regulatory affairs director Cambridge, MA
- training and compliance manager Cambridge, MA
- compliance director Cambridge, MA
- compliance manager Cambridge, MA