Strategic Lead, Clinical Regulatory Writing
Zenith LifeScience
Zenith LifeScience in the United States is seeking a Clinical Regulatory Writing Associate Director to lead complex regulatory writing across drug development programs. You will oversee authoring of strategic regulatory documents and collaborate with cross-functional teams to ensure timely, compliant submissions. The role requires extensive medical writing experience in pharma or CROs, strong leadership, and the ability to guide vendor writers and internal teams through MAA, IND, and NDA #J-18808-Ljbffr Zenith LifeScience
$200k
...apply. Responsibilities The Lead Clinical Laboratory Scientist position... ...receive certification, in writing, that your continued employment... ...with current laboratory regulatory requirements. The work performed... ...the organization's strategic plan, mission, vision, and values...RegulatoryPermanent employmentFull timeWork experience placementSeasonal workWork at officeRemote workTrial periodRelocation packageMonday to FridayFlexible hoursWeekend work$200k
...Duties Help The Lead Clinical Laboratory Scientist position... ...you receive certification, in writing, that your continued employment... ...with current laboratory regulatory requirements. The work performed... ...the organization's strategic plan, mission, vision, and values...RegulatoryPermanent employmentFull timePart timeWork experience placementSeasonal workWork at officeRemote workTrial periodRelocation packageMonday to FridayFlexible hoursWeekend work$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$122.25k - $176.58k
Job title: Lead, US Public Affairs & Patient Advocacy... ...Management: Manage strategic partnerships with rare... ...Medical Affairs, Regulatory Affairs, Market Access... ...Outcomes Research (HEOR), Clinical Development, Commercial... ...strategy, analysis, writing, and decision-making rather...RegulatoryFull timeRemote work$237.2k - $372.79k
...us as a Global Medical Lead, Dermatology in our... ...dermatology late-phase clinical studies in global medical... ..., market access, and regulatory strategies. This role... ...the projects by setting strategic direction. •... ...Expertise in study designs, writing protocols, analysis and...RegulatoryMinimum wageTemporary workWork at officeLocal areaRemote workWeekend work$120 - $170 per hour
Associate Director, Clinical Program Quality Leader Base... .... Serves as a Strategic Quality Thought Partner... ...mitigations are in place. Leads the clinical pre-... ...confirmed violations to regulatory authorities. Lead GCP... ...problems. Strong technical writing skills; able to write...RegulatoryTemporary workFor contractorsWork at officeImmediate startNight shift2 days per week- ...biostatistician to provide scientific and strategic leadership for our oncology... .... You will contribute to clinical development plans and study designs while serving as the lead statistician for development... ..., with a strong emphasis on regulatory submissions and adopting AI-...Regulatory
- ...57Remote50% Remote Responsibilities: Lead and manage clinical data management activities for oncology... ..., and quality standards. Provide strategic oversight and direction to CRO clinical... ...in alignment with study protocols and regulatory requirements. Oversee the design,...RegulatoryWork at officeRemote work
$293k - $358k
Remixtherapeutics is seeking a Program Team Leader (PTL) for REM-422, who will be accountable for strategic direction and operational execution. The ideal candidate will integrate clinical, regulatory, and commercial functions into a cohesive team aimed at achieving successful...Regulatory- ...Sr. Director of Biostatistics to serve as the statistical lead for various clinical programs. You will provide technical leadership and statistical... ...teams to ensure successful clinical study designs and regulatory submissions. The ideal candidate holds a PhD in statistics...Regulatory
$213k - $396k
...The PositionRoche’s Clinical Development organization... ...improvement to patients.The Lead Medical Director leads... ...other CST members, regulatory and other internal... ...responsible to ensure strategic and operational alignment... ...in scientific writing (e.g. manuscripts, grants...RegulatoryFull timeLocal areaRelocation package$230.9k - $384.8k
...Medical Evidence Strategy Lead within the COVID-19... ...in support of regulatory requirements, public health... ...leadership to set the strategic goals of the COVID-19... ...authoring or overseeing the writing of the first draft of... ...including research, clinical development, epidemiology...RegulatoryPermanent employmentWork experience placementSeasonal workH1bLocal areaVisa sponsorshipWork visaRelocation package$119.7k - $222.3k
...PK Sciences representative to lead the development and use of... ...enabled strategies to transform clinical pharmacology support of... ...based applications to support strategic, scientific and operational leadership... ...and interactions with regulatory agencies, as appropriate Proactively...Regulatory$310.9k
...Product Development Team (PDT) lead has primary responsibility... ...the planning and directing of clinical research activities involving... ...execution, monitoring, analysis, regulatory reporting, publication, and... ...communication verbally, in writing, and during presentationsPreferred...RegulatoryFull timeFor contractorsLocal areaVisa sponsorshipFlexible hours- ...seeking an experienced Associate Director of Medical Writing to independently author and oversee clinical, regulatory, medical, and safety documents across the... ...brings strong scientific judgment and regulatory writing expertise, plus the ability to lead#J-18808-LjbffrRegulatory
$176.4k - $327.6k
...for a visionary Associate Director to lead Clinical Data Engineering within our Oncology Data... ...collaboration and growth. Drive strategic initiatives and partnerships across a matrixed... ...oncology clinical trials, including regulatory-compliant management of clinical biomarker...RegulatoryRemote work- ...assigned TCO medium to high complex clinical trials (Phase I/II) including leading Clinical Trial Team(s) (CTT).... ...development of clinical sections of regulatory documents like Investigators’... ...review to promote trial decisions and strategic planning• Contribution beyond...RegulatoryContract workLocal areaImmediate startRemote work
- 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... .... Our vision is to be an industry leading organization driving strategic...Regulatory
$100k - $186.3k
...Director to support and help lead operations of our... ...reproducibility and clinical relevance. ~ Translational... .... Contribute to strategic planning for center... ...: Contribute to grant writing, progress reports, and... ...: Ensure adherence to regulatory, ethical, and...RegulatoryFull time$92.5k - $124.25k
Ready to lead? Join ERM and help shape the future of sustainable... ...power sector, and we need a strategic leader who thrives on solving... ...through complex environmental and regulatory landscapes. In this role, you... ...projects.Exceptional writing, communication, and strategic...RegulatoryFull timeFixed term contractCasual workWork at officeRemote workFlexible hours$105.8k - $175k
...Senior Environmental Permitting Lead to drive the successful... ...environmental permitting strategy, regulatory interface, and high-quality... ..., technical editing, and strategic guidance across interdisciplinary... .... Strong technical writing, editing, and communication skills...RegulatoryFull timeLocal areaRemote workShift work$133.04k - $199.56k
...Job Title: Clinical Regulatory Writer, Associate Director / Manager... ...Director in Clinical Regulatory Writing, you'll play a pivotal role... ...to drug projects, authoring strategically important clinical-regulatory... ...acting as a submission lead. Lead internal/external...RegulatoryHourly payTemporary workWork at officeFlexible hours3 days per week$332.8k
...seeking a visionary and strategic oncology leader to serve as Vice President, Clinical Development. Reporting... ...executive will lead the clinical development... ...clinical, translational, regulatory, and competitive insights... ...Medicine, Medical Writing, and Pharmacovigilance...Regulatory$20.12 - $25.15 per hour
...focuses on performing the following Clinical Administration duties: Long-term strategic planning, determines strategic... ...equipment ordering/set-up. Takes a lead role in template creation and... ...projects. Assists in assuring regulatory compliance and completes rounds...RegulatoryWork experience placementCasual workWork at officeFlexible hours$117.71k - $171.2k
...is inviting applications for a Digital Clinical Lead. Healthcare has seen a renewed focus on... ...awareness of existing and emerging technology, regulatory, and market factors and assists in the... ...information. Demonstrates excellent writing, editing and oral communications skills...RegulatoryFull timeTemporary workPart timeWork at officeRemote workShift work$110k - $207.5k
...are looking forAs a senior member of the Strategic Implementation team within the Chief... ...Street Investment Management, you will lead a team of project managers and drive the... ...change, whether driven by growth ambitions, regulatory or industry change, evolving client needs...RegulatoryFull timeTemporary workRemote workFlexible hoursShift work- ...or MS and extensive experience to oversee complex drug program statistics. The role involves leading study-level decisions and collaborating with diverse clinical and regulatory teams. You will apply advanced statistical methods, drive innovative solutions, and...Regulatory
- Moderna Therapeutics is seeking a Manager, Clinical Supplies Systems to lead IRT systems across Moderna’s studies. You will partner with external... ...IRT expertise, vendor management experience, and knowledge of regulatory guidelines. #J-18808-Ljbffr Moderna TherapeuticsRegulatory
- Moderna is seeking a Manager, Clinical Supplies Systems to oversee and manage IRT systems across a growing portfolio of studies. You... ...a science-based degree, and strong knowledge of IRT, EDC, and regulatory guidelines. A proactive leader who can manage multiple projects...Regulatory
- ...subsidiary in Watertown, MA, seeks a Senior Advisor to lead external manufacturing activities for lipid-based modalities... ...timely delivery of DS/DP materials for preclinical and clinical programs, driving regulatory readiness and program success. The ideal candidate has...Regulatory
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