Clinical Regulatory Writing Lead — Associate Director
AstraZeneca GmbH
AstraZeneca is seeking an Associate Director / Manager Clinical Regulatory Writer in Boston, MA or Gaithersburg, MD (hybrid, 3 days onsite). You will lead complex clinical-regulatory writing across a portfolio, ensuring regulatory and quality standards and shaping the Submission Communication Strategy. Ideal candidates have 7+ years of medical writing experience or 2-7+ for manager level, and a Life Sciences degree. #J-18808-Ljbffr AstraZeneca GmbH
- ...Inc. in Boston is seeking an experienced Associate Director of Medical Writing to independently author and oversee clinical, regulatory, medical, and safety documents across the... ...scientific judgment and regulatory writing expertise, plus the ability to lead#J-18808-LjbffrRegulatory
$160k - $275k
Who we are:Kymera is a clinical-stage biotechnology... ...building an industry-leading pipeline of oral small... ...integrity and alignment with regulatory standards. Collaborate... ...with medical directors, regulatory affairs, translational... ...and excellent medical writing skills.Maintain a...Regulatory- ...Pharmaceuticals is seeking an Associate Director of Clinical Data Management in Boston. You will lead data management activities... ...inspection readiness to support regulatory submissions. The role... ...Operations, Biostatistics, Medical Writing, Pharmacovigilance, and Regulatory...Regulatory
$195k - $220k
...your career in science, clinical development,... ...Biopharma is seeking an Associate Director of Clinical Operations... ...candidate will initiate and lead clinical trials... ...investigator brochure, regulatory documents, clinical... ...Excellent communication, writing, and presentation...RegulatoryWorldwideFlexible hours$176.1k - $287.3k
...serious diseases. We are seeking an Associate Director to join our Clinical Scientist, Internal Medicine team... ...guidance and supports the development of regulatory documents; performs quality review... ...methodology, and solid medical writing skills Experience in all aspects of...RegulatoryWorldwide- ..., Inc. is seeking an experienced Clinical Scientist, Associate Director to support oncology development efforts... ...data interpretation, medical writing, and regulatory submission capabilities, with... ...business needs require. You will lead clinical data reviews, support medical...RegulatoryRemote job
$150k - $200k
Medical Writing Lead, Global Clinical Operations, Orion Pharma Cambridge, United Kingdom and 3 more (Hybrid) Job Description Orion Pharma is a... ...documents across all phases of drug development and global regulatory submissions, ensuring quality and compliance through...RegulatoryWorldwide$160.6k - $240.8k
...DescriptionGeneral Summary:The Clinical Study Quality Lead (SQL), Associate Director is responsible for advanced quality... ...areas to drive compliance with regulatory requirements to ensure the... ...concisely both verbally and in writing to internal and external customersExcellent...RegulatoryFull timeWork experience placementSummer workWork at officeRemote workFlexible hours2 days per week$142.5k - $256.5k
...diverse mRNA portfolio spanning development, clinical, and commercial products.You will... ...stability data into actionable program, regulatory, and supply decisions.This role blends deep... ...supply.Here’s What You’ll Do:Define and lead phase-appropriate stability strategies...RegulatoryPermanent employmentFull timeWork at officeWork from homeWorldwide$133.04k - $199.56k
Job Title: Clinical Regulatory Writer, Associate Director / Manager Location: Boston, MA OR Gaithesrburg, MD- Hybrid... ...Associate Director in Clinical Regulatory Writing, you'll play a pivotal role in... ...(cSCS) when acting as a submission lead. Lead internal/external authoring...RegulatoryHourly payTemporary workWork at officeFlexible hours3 days per week$154.4k - $242.55k
...Join us as Global Biomarker Lead, Inflammation, GI2 TAU based... ..., MA reporting to the Senior Director, Head Inflammation Biomarkers... ...strategies across preclinical and clinical-stage gastrointestinal and... ...protocols and documents submitted to Regulatory Agencies.• Establish and...RegulatoryMinimum wageTemporary workLocal area- Overview The Associate Director, Downstream, Emerging Modalities, is expected... ...) purification as well as lead program(s) with the goal to... ...Development, Formulation Development, Regulatory, Technical Operations,... ..., and aligned with early clinical development needs.Establish...RegulatoryFull timeTemporary workLocal areaFlexible hours
$154.4k - $242.55k
...Pharmaceutical Sciences and Precision MedicineThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU)... ..., and guidance to internal stakeholders, including Clinical, Pharmacovigilance, Legal, Scientific, Commercial,...RegulatoryMinimum wageTemporary workLocal area$160k - $240k
...Opportunity OverviewAs the Associate Director, GCP/GLP/GVP QA, you... ...quality execution of clinical studies. You will... ...and compliance with regulatory requirements and internal... .../compliance updates.Lead or assist with GCP... ...Excellent communication, writing, and presentation...RegulatoryContract workWork at officeImmediate startNight shift$169.4k - $266.2k
...you will report to the Director, Global Scientific Communications Group Lead. This is a hybrid role... ...members of medical affairs, clinical development, and... ...stakeholder needsManage medical writing agency, including... ...analysesCompliance and Regulatory: Excellent understanding...RegulatoryMinimum wageTemporary workFor contractorsFreelanceLocal areaRemote work$160k - $240k
...OverviewRhythm is seeking an Associate Director, Biostatistics to... ...support important clinical development programs.... ...hands-on statistical lead for assigned studies... ...partnering across clinical, regulatory, safety, data... ...presentation, and report-writing skills, with the...RegulatoryInterim roleWork at office- ...DescriptionGeneral Summary:The Associate Director, Medical Writing Science manages the overall... ...for document development for regulatory filings and coordinates the clinical sections of more complex regulatory... ...include inclusive market-leading benefits to meet our...RegulatoryFull timeWork experience placementSummer workWork at officeRemote workRelocation packageFlexible hours2 days per week3 days per week
- Ratio Therapeutics is seeking an Associate Director in Biology to lead preclinical oncology biology studies and pharmacology efforts. You will... ...collaboration across chemistry, radiochemistry, clinical, and regulatory groups to drive preclinical programs forward. #J-1...Regulatory
- ...Boston is seeking an Executive Medical Director to oversee 2+ clinical development programs in hematology.... ...Medical Directors and CDS, guiding regulatory strategy, and contributing... ...drive clinical development plans, CTD writing, and due diligence for business development...Regulatory
$181k - $194k
...Clinical Scientist, Associate Director Remote Role: Flexible schedule with occasional... ...Phase 3 results for our lead candidate, it’s an exciting... ...monitoring, data interpretation, regulatory documentation, and cross-... ...Data Management, Medical Writing, and Pharmacovigilance to...RegulatoryFull timeRemote workVisa sponsorshipWork visaFlexible hours$248.5k
...strategic medical guidance and leads the development of... ...beginning at the PE / DC Creates clinical development strategies for new... ...experts, investigators, and regulatory authorities in oncology, and... ...those groups and authorities Writes and reviews abstracts/manuscripts...RegulatoryWork at officeLocal area$161.5k - $218.5k
...PharmaceuticalsPosted: 2026-08-16Overview The Associate Director, Medical Education Marketing, US Congress and TLL Asset Lead will lead national strategy... ...teams to support internal clinical expertise and reinforce key... ...initiatives meet regulatory standards and strategic...RegulatoryFull timeTemporary workLocal area$185.37k - $308.95k
Associate Director, Medical Review Lead, MSRM Who we are At Agios, we are fueled by connections to transform rare... ..., ensuring medical accuracy, regulatory compliance, and high-quality safety... ...management activities, and development of clinical and regulatory documents....RegulatoryTemporary workRemote workWork from homeFlexible hours3 days per week$198.5k - $311.85k
...empower you to shine? Join us as an Associate Medical Director in our Neuroscience Therapeutic... ...The Associate Medical Director leads and drives strategy for clinical studies within the overall... ...consideration the medical, scientific, regulatory and commercial issues.Leads or...RegulatoryMinimum wageTemporary workWork at officeLocal areaRemote workNight shift$158.6k - $285.5k
...Oncology Therapeutic programs, specifically supporting the Clinical Study Lead in the development, execution and evaluation of Phase 1-3 clinical... ...studies to support both internal governance decisions and regulatory submissions.Here’s What You’ll DoBroadly stated, in...RegulatoryPermanent employmentFull timeWork at officeWork from home$183.77k - $275.65k
...Job Title: Translational Medicine Lead, Associate Director, Oncology Location: Cambridge, MA... ...edge biomarker science into confident clinical decisions that change patient outcomes... ...Ensure all work meets applicable quality, regulatory, ethical, safety, and AstraZeneca...RegulatoryHourly payTemporary workWork at officeFlexible hours3 days per week$169.4k - $266.2k
About the Role The GMAO External Engagement Lead will be responsible for collaboratively... ..., ensuring activities address evolving clinical practice gaps and emerging data. Build... ...Collaborate with Ethics & Compliance, Legal, and Regulatory to ensure compliant execution of all...RegulatoryMinimum wageTemporary workLocal area$136.51k - $204.77k
Job Title: Associate Director, CMC Lead Job Title: Associate Director, CMC Lead Introduction to role... ...for reliable, phase-appropriate clinical supply. Your decisions will determine... ...readiness. IND/IMPD Readiness: Lead CMC regulatory strategy; guide and contribute to...RegulatoryHourly payTemporary work$146.3k - $234.1k
...Your Contribution: Lead the analysis, interpretation, and reporting of clinical pharmacokinetic data Drive PKPD modeling, exposure-response analyses, and translational... ...pharmacology and pharmacometrics input into regulatory documents (e.g., IBs, briefing books, NDA/BLA...Regulatory$160k - $240k
Who we are:Kymera is a clinical-stage biotechnology... ...building an industry-leading pipeline of oral small... ...an impact:As the Associate Director, Analytical Development... ...sections of late phase regulatory submissions (e.g.,... ...requirementsPrior experience writing analytical sections...RegulatoryContract work
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