Lead Principal Medical Writer — Regulatory & Clinical Docs
Barrington James
Urgent Permanent Principal Medical Writer | France, UK, Spain, Germany *ONLY APPLICANTS FROM THESE COUNTRIES WILL BE CONSIDERED* We are supporting a global clinical research organisation seeking a Senior / Principal Medical Writer to join a growing international medical writing team. You will lead the development of key clinical and regulatory documents including protocols, CSRs, IBs, and submission materials, ensuring scientific accuracy and compliance with ICH-GCP, FDA, and EMA guidelines. Working closely with global teams across clinical operations, biostatistics, regulatory affairs, and medical affairs, you will translate complex clinical data into high-quality regulatory and publication‑ready outputs. The role also includes mentoring junior writers. Requirements 4–7+ years’ medical writing experience (CRO, pharma, biotech) Strong clinical/regulatory documentation expertise Ability to interpret complex clinical and statistical data Experience in fast‑paced, multi‑project environments Location: France, UK, Spain, Germany #J-18808-Ljbffr Barrington James
- Veristat LLC is seeking a full-time Principal Medical Writer to independently plan and prepare regulatory documents and medical communications. This remote role involves supporting all phases of product development while collaborating with cross-functional teams. The ideal...PrincipalRegulatoryRemote jobFull time
$80.6k - $175.7k
...Syneos Health® is a leading fully-integrated... ...accelerate progress. Our Clinical Solutions team... ...of complex medical writing deliverables... ...Adheres to established regulatory standards,... ...experienced medical writers on complex documents... ...role. Description Principal Medical Writer - Publications...PrincipalRegulatoryRemote workFlexible hours$96k - $150k
Join to apply for the Principal Regulatory Medical Writer role at Aquestive Therapeutics 1 day ago Be among... ...Principal Regulatory Medical Writer to lead and contribute to key regulatory... ...responses to regulatory inquiries, and clinical study reports (CSRs). Additionally,...PrincipalRegulatory16 hoursFull timeContract workLocal area- Ethos is working with a leading foundational AI lab to find experienced senior medical writers who can help train their latest language model... ...seek candidates with 5+ years in clinical research, biomedical science, or pharma/regulatory affairs to create, evaluate, and...RegulatoryRemote job
- Syneos Health is seeking a Principal Medical Writer for publications to lead complex medical writing on clinical study and regulatory projects. You will craft high-quality documents, provide regulatory guidance, and mentor junior writers within Clinical Solutions teams...Regulatory
$95k - $105k
...therapeutic advancements, and clinical data. + Adhere to... ...+ Assign tasks to internal writers and freelancers, managing workflow... ...project lifecycle, adhering to medical/legal/regulatory (MLR) review process... ...**Position Overview:** The Principal Medical Writer is responsible...PrincipalRegulatoryTemporary workFreelance- Precision Medicine Group seeks a Senior Medical Writer/Principal Medical Writer to lead development of clinical study documents with high quality and on-time delivery. The role emphasizes planning, writing, editing, formatting, and QC across protocols, IBs, ICFs, DSURs,...Remote job
- YO AI Labs is seeking an experienced Medical Writer / Clinical Document Author to develop, review, and evaluate clinical and regulatory documents with a focus on scientific accuracy and regulatory compliance. The role emphasizes high-quality medical writing, CSR authoring...RegulatoryRemote job
- Clario is seeking a Senior Principal Scientific Affairs Advisor - Gastroenterology... ...leadership across global clinical trials, emphasizing imaging... ...with Clinical Operations, Medical & Scientific Affairs, Product... ...in imaging-based trials, regulatory environments, and publication...PrincipalRegulatory
- A leading global clinical research organization is seeking a Senior Medical Writer I for a 12-month FTC, fully remote. In this role, you will spearhead the development and... ...and possess exceptional communication and regulatory knowledge. Competitive salary and benefits,...RegulatoryRemote jobFixed term contract
- Real Chemistry seeks a Principal Medical Writer in New York to lead high‑quality medical content across multiple therapy areas, manage writing teams, and... ...contact. You will partner with senior leaders to shape clinical strategy and ensure excellence across deliverables....Principal
- Langland is hiring a Principal Medical Writer in the United States, responsible for leading and mentoring a medical writing team, setting editorial direction, and delivering high-quality scientific content. The ideal candidate will have over 5 years of experience within...Principal
- ...emphasizes sterile compounding, IV admixture, staff leadership, and regulatory compliance to ensure safe, effective patient care. Ideal... ...or BS in Pharmacy with active Georgia license and 5-7 years of clinical operations experience, preferably in home infusion or acute...Regulatory
- You will lead Yale's Clinical Trials Office regulatory division, directing Regulatory Managers, Regulatory Affairs Specialists, and Research Assistants. You will develop workflows, implement policies, monitor compliance, and educate colleagues to support the corporate regulatory...RegulatoryRemote jobWork at office
- ...prove others wrong About the Role (Lead AI Medical Editor): We're looking for a Lead... ..., and references for medical accuracy, clinical soundness, and compliance with FDA/EMA... ...re Looking For Deep medical and regulatory expertise: Strong understanding of life...Regulatory
- ...Responsibilities: Lead data management activities as a program... ...in support of Alnylam clinical studies. Lead database build... ...and Risk Management, and Regulatory Affairs; CROs, central and local... ...using standardized medical terminology, including MedDRA...PrincipalRegulatoryWork experience placementLocal areaFlexible hours
$62k - $175.7k
Senior/Principal Medical Editor - FSP (Regulatory Documents)Syneos Health is a leading fully-integrated life sciences services organization... ...and accelerate progress.Our Clinical Solutions team members act with... ...and updates the lead medical writer, project manager, and/or...PrincipalRegulatoryContract workFlexible hours- Principal Medical Writer The Principal Medical Writer independently plans and prepares a range of regulatory documents and medical communications to support all phases of product development. The primary responsibilities of the position are organizing, analyzing, interpreting...PrincipalRegulatoryContract workWork at officeRemote workWorldwideFlexible hours
$85k - $98k
...Media, Inc. is seeking a Medical Writer to join the PRI team.... ...with scientific leads. The Medical Writer is... ...objectives Assess and ensure clinical accuracy of all... ...client medical/legal/regulatory reviews as needed Maintain... ...Suite such as Slides, Docs in addition to online...RegulatoryWork at officeLocal areaRemote workFlexible hours- MMS, a data-focused CRO, seeks an experienced Medical Writer in New York to critically evaluate literature, select materials for study design, and prepare regulatory documents. You will write and edit protocols, investigators’ brochures, study reports, consent forms, safety...Regulatory
- Veristat is seeking a Principal Medical Writer to independently plan and prepare regulatory documents and medical communications across product development. You will organize, analyze, interpret, and present scientific data per ICH guidelines and company standards, and...RegulatoryRemote job
- Syneos Health is seeking a Senior/Principal Medical Editor for Regulatory Documents, supporting FDA and EU guidelines... ...across study teams. The role leads editorial efforts, mentors staff,... ...senior/lead editorial position within Clinical Solutions. #J-18808-Ljbffr Syneos...Regulatory
- Syneos Health/ inVentiv Health Commercial LLC is seeking a Clinical Research Associate to perform critical site management and monitoring activities, ensuring compliance with regulatory standards. This role requires a Bachelor's degree or RN in a relevant field, combined...RegulatoryFlexible hours
$50 - $80 per hour
...Job Description Job Description Job Title: Medical Writer / Clinical Document Author Location: Remote Job Type: Contractor Pay:... ...Document Author to develop, review, and evaluate clinical and regulatory documents while ensuring scientific accuracy, regulatory...RegulatoryRemote jobFor contractors- ...largest privately held, multispecialty medical group in New York, providing high-... ...Position Title: Operational Compliance Lead - RCM & Clinical Documentation (Clinical Background Required... ...coding standards and payer‑specific regulatory requirements as guidelines evolve....RegulatoryFull time
- Syneos Health, Inc. seeks a Principal Statistician for Early Phase, fully home based. Lead statistical activities across trials, mentor biostatisticians, and contribute to SAPs and regulatory submissions. With a PhD/MS in statistics and strong R/SAS skills, collaborate...PrincipalRegulatoryRemote jobWork from home
$140k - $190k
GFT is seeking an experienced Principal Environmental Planner/NEPA Lead. This hybrid position may be located in... ...processes, ecological and regulatory assessments, and environmental remediation... ...and pet insurance, in addition to medical, dental, vision, disability, and...PrincipalRegulatoryFull timeFor subcontractorRemote work- A leading healthcare institution in New York seeks a Clinical Pharmacy Manager for the Investigational Drug Service. The role involves optimizing... ...for clinical trial patients, overseeing medication management, and ensuring regulatory compliance. The ideal candidate will...Regulatory
$83.89k
...supportive housing service provider in New York is seeking a Clinical Coordinator to supervise case managers in a supportive housing... ...Director and manage a caseload while ensuring compliance with regulatory standards. Required qualifications include a Master's degree in...Regulatory- ...hands on work experience in clinical data management within a pharmaceutical... ...of clinical trial processes, regulatory requirements (GCP, ICH... .... Experience with medical coding dictionaries ( MedDRA,... ...). Minimum of 3+ years of lead or project management experience...Regulatory16 hoursFull timeWork experience placementWork at officeRemote work
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