Clinical Regulatory Writing Associate Director
Zenith LifeScience
The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important clinical-regulatory documents that are label focused and align with project strategies, regulatory requirements, and communications best-practices. We support the Company’s core therapeutic areas in all phases of clinical development. Our vision is to be an industry leading organization driving strategic communication excellence to achieve successful submissions and approvals. The Clinical Regulatory Writing Associate Director is expected to: Independently manage clinical regulatory writing activities across a complex portfolio of work. Author the most complex clinical-regulatory documents within a program by ensuring that relevant regulatory, technical and quality standards are achieved, and that relevant processes and best practice are applied. As part of a clinical delivery or submission team, provide strategic communications leadership to projects, establish communication standards and best practice, and continuously advocate for quality and efficiency. When acting as a submission lead, drive the development of the clinical Submission Communication Strategy (cSCS). Lead internal/external authoring teams and provide strong partnership with vendor medical writers to ensure delivery to time and quality. Drive the clinical interpretation of complex data and information and condense it into clear, concise and accurate messages that address customer information requirements. Be a strategic thinker and demonstrate strategic review capabilities. Proactively collaborative with other functions at the program level. Support the development of Clinical Regulatory Writing Managers. Drive continuous improvement and operational excellence from a communications leadership perspective, including representing the skill on drug and non-drug projects, as required Education, Qualifications, Skills and Experience Life Sciences masters degree in an appropriate discipline. Significant medical writing experience in the pharmaceutical industry or CRO. Ability to advise and lead communication projects. Understand drug development and communication process from development, launch through life cycle management. In depth knowledge of the technical and regulatory requirements related to the role Desirable: Advanced degree in a scientific discipline (Ph.D.). #J-18808-Ljbffr Zenith LifeScience
- ...We are now recruiting an Associate Director, R&I Clinical Regulatory Writing (CReW). As part of a clinical delivery or submission team, the Associate Director provides strategic communications leadership to projects, establishes communication standards and best practice...SuggestedHourly payContract workTemporary work
AstraZeneca
Gaithersburg, MD3 hours ago $136.78k - $205.18k
...Associate Director, Clinical Regulatory Writing (CReW) We are recruiting an Associate Director, Clinical Regulatory Writing (CReW). The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important clinical...SuggestedHourly payTemporary workAstraZeneca
Gaithersburg, MD3 days ago- Zenith LifeScience in Gaithersburg, Maryland, is looking for a Clinical Regulatory Writing Associate Director. This role involves independently managing clinical regulatory writing activities and authoring complex regulatory documents. The candidate should have substantial...Suggested
$200k - $220k
...alternative application process. Associate Director/Senior Manager Regulatory Affairs Full-time Regular Management... ...'s quality, CMC, preclinical, and clinical drug development programs,... .... Specifically assisting with the writing and/or editing of scientific sections...SuggestedFull timeWork at office- ...Are you passionate about Regulatory Writing? Would you like to have an impact on patients’ lives... ...fitness center, employee healthcare clinic, electric vehicle charging stations,... .... We are now recruiting an Associate Director, Clinical Regulatory Writing (CReW)....SuggestedHourly payTemporary work
$110k - $125k
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The Associate Director of Real‑World Data Science is an expert in analysis... ...health records (EHR), and clinical trial data, data linking/ tokenization... ...external groups, including regulatory authorities, key opinion... ...psychometrics, and medical writing. Data Utilization: Strong...Temporary workFor contractorsFlexible hours$162k - $190k
Supernus Pharmaceuticals is seeking a Clinical Data Manager to lead the Clinical Data Management team. This role involves developing processes, ensuring data quality, and managing vendor relationships. The ideal candidate has significant experience in data analytics and...$162k - $190k
Associate Director Clinical, Data Management Requisition Number : ASSOC001671 Full-Time Hybrid Locations... ...data in compliance with global regulatory requirements. Provide consultation,... ...study databases and related documents. Write SOPs and contribute to the...Full timeWork at officeVisa sponsorship- A clinical-stage biopharmaceutical company is seeking an Associate Director, Bioinformatics in Rockville, Maryland. This role involves providing technical leadership for clinical development programs, managing a team, and ensuring high-quality data generation and analysis...
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POSITION SUMMARY The Associate Director, Technical Writing will lead our technical writing team. This role is responsible for producing high-quality... ..., ensuring accuracy, clarity, and compliance with regulatory requirements. Stakeholder Collaboration: Work closely...Temporary workWork at officeRemote workFlexible hours$151.23k - $226.84k
...and connect on key projects. An Associate Director in the Quantitative COA Science team,... ...Excellence, will have experience in the use of clinical outcomes assessments (COA) such as... ...and external requirements, including regulatory or compliance standards.- Provide...Hourly payTemporary workWork at office3 days per week$110k - $125k
A global healthcare agency is seeking a talented Associate Medical Director to lead the development of high-impact medical content. This role involves leveraging medical writing and scientific storytelling to enhance healthcare provider education and patient outcomes....Remote job- ...and research for review with the senior director of ethics and the BOE Chairs. Assist in... ...diverse constituencies Skills Demonstrated writing and editing abilities Demonstrated... ...with people in a positive manner #J-18808-Ljbffr Tennessee Society of Association ExecutivesWork at office
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...visionary and operationally astute Associate Director of Artificial Intelligence,... ...science and life-saving clinical research. Sitting at... ...Proposal Authorship: Personally write key sections of technical... ...valued at $15M+. ~ Regulatory Experience: Proven track record...Local areaImmediate startFlexible hours$170k - $206k
...degree with 6+ years minimum relevant work experience. Strong track record of scientific innovation, publication, and delivery of clinical candidates. In-depth knowledge of the entire drug R&D processes, expertise in ADME/PK, pharmacology, CMC, formulations and computational...Work experience placementVisa sponsorshipSupernus Pharmaceuticals
Rockville, MD3 hours ago$88k - $107k
...Bullis School seeks a full-time Associate Director of College Counseling for the 2026-27 academic year to play an essential role in guiding... ...college counseling program, mock admissions programs, essay-writing workshops, an August application workshop, and a comprehensive...Full timeTemporary workSummer workWork at officeBullis School
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...What you have to offer ~ Bachelor’s or higher degree in a relevant scientific or technical field ~10 -12+ years experience in Clinical Operations/Data Management ~ Strong understanding of Clinical business processes ~ Experience in process development, mapping,...$142.38k - $213.57k
About the Position We are seeking a highly motivated Associate Director with a proven track record of scientific excellence and project leadership... ...strategy and be responsible for the delivery of key pre‑clinical data that support a strong biological rationale for program...Hourly payTemporary work- ...Kolon TissueGene, Inc. is seeking an Associate Director, Bioinformatics to provide hands-on technical... ...and operational leadership supporting clinical development programs. This role is... ...Clinical Operations, Medical Affairs, Regulatory, and external partners to align data...
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Job title: Translational Science, Associate Director Location: Gaithersburg, MD. Are you a visionary... ...translational understanding of clinical trial data. You will oversee translational... ...the authoring of relevant sections of regulatory documents. Understanding of the full...Hourly payTemporary work$134k - $168k
...Platforms organization at World Wide Technology is hiring an Associate Client Solutions Director (ACSD) to lead delivery of strategic digital and AI... ...functions such as proposal strategy, pitch approach, contract writing, and negotiation strategy Partner with Sales to...Full timeContract workShift workWorld Wide Technology
Gaithersburg, MD2 days ago- AstraZeneca in Gaithersburg, MD is seeking a Translational Science Associate Director to drive translational and biomarker objectives across... ...with CROs and collaborators, connect target biology to clinical outcomes, and act as a translational lead on global product...
$176k - $203k
...on patient outcomes. Job Summary The Associate Director, Patient Advocacy & Communications will... ...industry, policy, competitive, and regulatory landscapes to proactively identify opportunities... ...on education and disease awareness, clinical milestones, and advocacy partnerships....Visa sponsorship$160k - $185k
...market that are making a real impact on patient outcomes. Job Summary The Associate Director, Data Analytics defines and executes study-level data and analytics strategies for monitoring clinical study conduct and performance. This position leads the analytics team and...Visa sponsorship$115k - $173k
The Associate Director, External Operations, Cell Therapy - External Supply Management Leads external... ...Supports programs across development, clinical, scale‑up, validations, launch... ...Leadership, Process Development, Quality, Regulatory, Procurement, and Finance to ensure...Contract workTemporary work$151.23k
...strategy to generate and communicate compelling health outcomes evidence. Your work will connect ground‑breaking research with real clinical practice—advancing our pipeline, informing access, and improving the patient experience across the entire journey from diagnosis...Contract workTemporary workWork at officeFlexible hours3 days per week$148.37k - $190k
About The Role This director role sits within AstraZeneca's Enterprise AI Transformation... ...scientific concepts credibly across research, clinical, and business audiences 10+ years in... ...transformation experience Medical writing or scientific communications background...Temporary workWork at officeShift work- ...ability to work independently whilst coordinating with a larger team. Excellent organization and time management skills. Ability to write clearly and concisely with attention to detail and target audience focus. Strong analytical and critical thinking skills. Language...Contract workWork at officeRemote work
- ...Assistance, Inc., (SGA), is searching for an Associate Principal Content Manager for a CONTRACT assignment with one of our premier Regulatory clients in Rockville, MD or New York, NY.... ...by: analyzing training needs and topics; writing content and learning objectives;...Contract workWork at office
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