Sponsor Dedicated - Sr. Principal Medical Writer - Regulatory Submission Docs (ISE/ISS/Clinical Over
$114k - $210.9kLadders
For our client, we are seeking a Sr. Principal Medical Writer to join the team of a leader in the Healthcare space. This remote role will support global regulatory submission efforts, with a primary focus on preparing high-quality clinical and regulatory documents for complex development programs. The position will partner closely with cross-functional teams to ensure submission materials are scientifically sound, compliant with global requirements, and delivered on schedule. In addition, this writer will help drive process consistency, mentor junior staff, and support efficient execution across multiple projects. Location: Remote Compensation: $114,000 – $210,900 annually Responsibilities Develop regulatory documents for global submission in line with ICH and client standards Manage medical writing projects, including timelines and cross-functional communication Participate in cross-functional meetings to discuss medical writing deliverables and processes Review related documents such as protocols and statistical analysis plans as needed Engage in cross-functional process improvement initiatives Define and write standard operating procedures for efficient document preparation Mentor junior medical writing staff and manage internal and contract resources Qualifications Bachelor's degree required; advanced degree preferred in a relevant scientific, clinical, or regulatory field Minimum of 5 years of medical writing experience in the biopharmaceutical or CRO industry, or comparable clinical/preclinical development experience Proficient in organizing and communicating clinical information with minimal oversight Strong organizational, time management, and project management skills Excellent verbal, written, and interpersonal communication skills for effective teamwork Knowledge of global regulatory requirements and therapeutic areas in all phases of clinical development is desired Proficient in MS Word and experienced with electronic document management systems Benefits Company car or car allowance Comprehensive health benefits including medical, dental, and vision 401k with company match Eligibility for Employee Stock Purchase Plan Potential for commissions or bonuses based on performance Flexible paid time off (PTO) and sick time Our client is an equal opportunity employer. #J-18808-Ljbffr Ladders
- ...Syneos Health, Inc. seeks a Sr. Principal Medical Writer to lead regulatory submission documents across global programs, including ICH-compliant materials (ISE/ISS/Clinical Overview). Remote role with major responsibilities for strategy, timelines, and cross-functional...PrincipalSeniorRegulatoryRemote work
- ...completion of medical writing... ...established regulatory standards, including... ...medical writers on complex projects... ...Health Over the past 5 years... ...global company dedicated to advancing... ...We assemble clinical teams where everyone... ...Overview Sr Medical... ...Publications - Sponsor Dedicated - Remote...SeniorRegulatoryContract workRemote workWorldwideFlexible hours
- ...Sr Principal Medical Writer job at ICON Strategic Solutions... ...intelligence and clinical research organization... ...clinical and regulatory documents,... ...and regulatory submissions. Ensuring all documents... ...network of over 80,000 independent... ...and values. We’re dedicated to providing an...PrincipalSeniorRegulatoryRemote workFlexible hours
$56.4k - $95.9k
Sponsor dedicated - Sr Clinical Trial Supplies Associate - USA Office Based (NY or NJ... ..., and other applicable regulatory requirements High level of... ...Health benefits to include Medical, Dental and Vision Company... ...Get to know Syneos Health Over the past 5 years, we have...SeniorRegulatoryContract workWork at officeWorldwideFlexible hours- ...Sr CRA 0.5FTE Estonia - Sponsor-dedicated Syneos Health® is a leading fully-integrated... ...progress. Our Clinical Solutions team... ...remotely) ensuring regulatory, ICH-GCP and/or Good... ...source documents and medical records. Verifies required... ...know Syneos Health Over the past 5 years,...SeniorRegulatoryContract workInterim roleLocal areaImmediate startRemote work
- ...Experienced Clinical Research Associate - Sponsor Dedicated Syneos Health is a leading fully... ...translate unique clinical, medical affairs and commercial... ...site or remotely) ensuring regulatory, ICH‑GCP and/or Good... ...to know Syneos Health Over the past 5 years, we have...RegulatoryContract workInterim roleLocal areaImmediate startRemote workFlexible hours
- ...Senior CRA - Sponsor dedicated - Home Based Germany Syneos... ...accelerate progress. Our Clinical Solutions team... ...or remotely) ensuring regulatory, ICH-GCP and/or Good... ...source documents and medical records. Verifies required... ...to know Syneos Health Over the past 5 years, we...SeniorRegulatoryContract workInterim roleLocal areaImmediate startRemote workWork from home
- ...Description Experienced Clinical Project Manager - Inflammation (Sponsor Dedicated/ Remote- US only)... ...translate unique clinical, medical affairs and commercial... ...Technical & Regulatory Expertise Thorough knowledge... ...know Syneos Health Over the past 5 years, we have...RegulatoryFull timeContract workInterim roleImmediate startRemote workFlexible hoursShift work
- ...Principal Medical Writer - Publications Syneos Health® is a leading... ...progress. Our Clinical Solutions team members... ...development plans; IND submissions; integrated summary... ...Adheres to established regulatory standards, including... ...know Syneos Health Over the past 5 years, we...PrincipalRegulatoryContract work
$109.2k - $273k
Join IQVIA’s Sponsor-Dedicated FSP team and help advance healthcare... ...support for clinical development and drug... ...evidence that informs regulatory, safety, and clinical... ...supporting regulatory submissions or interactions with... ...commercialization of innovative medical treatments to help...SeniorRegulatoryFull timePart timeImmediate startRemote workWorldwide- ...Senior Medical Writer - Clinical Development Immix Biopharma, Inc. United States / Remote / LA, CA Our 3 Core Values Intelligence... ...for preparing, reviewing, and editing regulatory documents required for submission to the U.S. Food and Drug Administration (FDA) and...SeniorRegulatoryOdd jobRemote work
- ...Carrot Life Sciences is partnering with a growing CRO to recruit a Medical Writer. This role blends clinical and regulatory writing with document quality control and publishing, supporting regulatory submissions. You will interpret study results, prepare clinical...RegulatoryRemote work
$74.5k - $197.5k
...Clinical Research AssociatePerform monitoring and site management... ...and guidelines, and sponsor requirements.Essential FunctionsPerform... ...studies by tracking regulatory submissions and approvals, recruitment... ...commercialization of innovative medical treatments to help improve...RegulatoryFull timePart timeLocal areaImmediate startWorldwide- ...serve as a full-time Principal Investigator at a clinical research site in... ...infrastructure, and dedicated recruitment and study... ...will provide medical leadership and oversight for industry-sponsored clinical trials, primarily... ...Research and Regulatory Oversight Ensure...PrincipalRegulatoryFull timeMonday to Friday
- ...activities of a clinical trial in accordance... ...visits, and regulatory and/or IRB document... ...Coordinator dedicated to sponsor and investigator... ...compilation and submission of protocols and... ...Jefferson, which is principally located in the... ...of Sidney Kimmel Medical College,...SeniorRegulatoryDaily paidFull timeTemporary workPart timeWork at officeRemote workFlexible hoursShift work
- ...TransPerfect seeks an organized, motivated senior medical writer to lead planning and preparation of high-quality clinical regulatory documents in collaboration with Clinical Development, Regulatory, and Program Management teams. The role requires 5+ years of medical writing...SeniorRegulatory
- ...Syneos Health is seeking a Sr CRA I/II for a sponsor-dedicated role based in Madrid, Spain. The candidate will conduct site qualification, initiation... ..., and close-out visits, on-site or remotely, ensuring regulatory and GCP compliance. The role requires 5+ years in...SeniorRegulatoryRemote work
- ...you will work in a sponsor-dedicated model, supported... ..., with over 90 sponsor partnerships... ...worldwide. Senior Clinical Research Scientist... ...interpretation, and regulatory deliverables that... .... Lead medical monitoring activities... ...CSR), regulatory submissions, and publication...SeniorRegulatoryRemote workWorldwide
$145k - $177k
...BridgeBio Pharma, is dedicated to developing... ...lead to significant medical complications throughout... ...What You’ll Do As a Sr. Clinical Research Associate/Clinical... ...brochures, and regulatory submission materials under the... ...biotechnology or pharmaceutical sponsor organization....SeniorRegulatoryWork at officeRemote workFlexible hours- ...TransPerfect is seeking a senior medical writer to lead the planning and preparation of high-quality clinical regulatory documents, partnering with Clinical Development, Regulatory, Biostatistics, and Program Management to support drug development on tight timelines. You...SeniorRegulatory
- ...Job Summary: We are seeking a Principal/Sr. Principal Regulatory Scientist who will be responsible... ...and Responsibilities: Prepare submissions to gain approvals for clinical research and commercialization... ...industry, preferably Medical Devices industry Demonstrated...PrincipalSeniorRegulatory
- TransPerfect is seeking a senior medical writer to lead planning and preparation of high-quality clinical regulatory documents. You'll collaborate with Clinical Development, Regulatory, and other teams to deliver protocols, reports, and modules on brisk timelines. Responsibilities...SeniorRegulatory
- ...Activation Specialist - Sponsor-dedicated; 0.8 FTE Syneos... ...progress. Our Clinical Solutions team... ...Manager. Forecasts submission/approval... ...and other local regulatory authorities or hospital... ...typically include the Principal Investigator/... ...know Syneos Health Over the past 5 years,...RegulatoryContract workLocal area
- ...seeking a highly skilled virtual Principal Investigator for oversight of all clinical trials in a remote, part-time... ...an MD/DO with an active medical license, GCP training, and prior... ...staff while complying with regulatory standards and sponsor requirements. #J-18808-Ljbffr...PrincipalRegulatoryPart timeRemote work
- ...Hearst, with over 100 years of experience... .... As a Principal Product... ...closely with clinical and technical... ...alternatives, and regulatory changes. Build... ...year for company-sponsored events Medical, dental, vision... ...organization dedicated to patient-focused... ...types: pdf, doc, docx, txt,...PrincipalRegulatoryFor contractorsH1bRemote workVisa sponsorshipFlexible hours
- Syneos Health, Inc. seeks a Senior/Principal Medical Writer with a regulatory focus to lead regulatory documents for Phase 2/3 programs. You will coordinate with data management, biostatistics, regulatory affairs, and medical affairs to deliver high-quality documents on...PrincipalSeniorRegulatoryRemote job
- ...Clinical Research Analyst Under general supervision, analyzes... .... Assists with protocol submissions, database enhancements,... ...sites. Assists the Principal Investigator and regulatory staff in the preparation... ...Strong Knowledge of Industry sponsored clinical research...SeniorRegulatory
- ...Veristat in the United States is seeking a Senior Medical Writer to independently plan and prepare regulatory documents and medical communications across all stages of product development. You will organize, analyze, interpret, and present scientific and statistical information...SeniorRegulatory
$79.8k - $139.6k
...Senior Site Contracts Manager (Sponsor Dedicated /Remote – US Based) Syneos... ...accelerate progress. Our Clinical Solutions team members act... ...Health benefits to include Medical, Dental and Vision, Company... ...Get to know Syneos Health Over the past 5 years, we have worked...SeniorContract workImmediate startRemote workFlexible hours$144.8k - $217.2k
...biotechnology company dedicated to discovering... ...Senior Manager, Clinical Data Management... ...The role provides sponsor oversight of outsourced... ...trial execution, regulatory compliance, and... ..., data cleaning, medical coding, external... ...system lock, and submission readiness Review...SeniorRegulatory
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