Medical Writer / Clinical Document - Remote
$50 - $80 per hourYO AI Labs
Boston, MA
- Remote job
Job Description
Job Description
Job Title: Medical Writer / Clinical Document Author
Location: Remote
Job Type: Contractor
Pay: $50–$80/hour
We are seeking an experienced Medical Writer / Clinical Document Author to develop, review, and evaluate clinical and regulatory documents while ensuring scientific accuracy, regulatory compliance, and high-quality medical writing.
Key ResponsibilitiesAuthor and review Clinical Study Reports (CSRs) and other regulatory documents.
Interpret clinical protocols and ensure compliance with ICH guidelines.
Verify scientific accuracy using source data, TFLs (Tables, Figures, and Listings), and study documentation.
Review safety documentation, including DSURs and PSURs/PBRERs.
Provide structured feedback and collaborate with cross-functional teams.
Support AI-assisted documentation evaluation and quality improvement initiatives.
Regulatory Medical Writing
Clinical Study Report (CSR) Authoring
ICH E3 Guidelines
Scientific Accuracy Assessment
Source Data Verification
Clinical Protocol Interpretation
TFL Analysis
eCTD Knowledge
Strong Written Communication & Collaboration
5+ years of regulatory medical writing experience in a Sponsor, CRO, or consulting environment.
Experience authoring Clinical Study Reports and regulatory documentation.
Strong knowledge of ICH E3, ICH E2F, ICH E2C, and eCTD requirements.
Advanced degree in Life Sciences, Pharmacy, Medicine, or a related field (MD, PharmD, PhD, or MSc).
Experience in oncology and haematology is preferred.
Vacancy posted 5 days ago
Similar jobs that could be interesting for youBased on the Medical Writer / Clinical Document - Remote in Boston, MA vacancy
- A leading medical device company is seeking a Medical Writer to develop clinical documents for an innovative project. This role focuses on drafting a Clinical Development... ...and Europe are encouraged to apply. This is a remote role with an initial contract of 6-12 months....Remote workDocumentContract work
Confidential
Seattle, WA2 days ago - ...Working remotely as a contract Clinical Medical Writer, the candidate will develop high-quality regulatory documents for submission to Sponsors and regulatory agencies, ensuring compliance and scientific rigor. Key responsibilities: Lead the planning, development, and...Remote workDocumentContract work
Virtual Vocations Inc
United States2 days ago $116k - $128k
...Information Strategies, LLC is looking for a Senior Medical Writer specializing in clinical documentation. This role involves leading document authorship, interfacing... ...plus bonuses, with various benefits including remote work options and medical insurance. #J-18808-Ljbffr...Remote workDocumentSynchrogenix Information Strategies
Oklahoma City, OK1 day ago- Celerion is seeking a Medical Writer to work remotely. The role analyzes and interprets safety results from clinical trials, compiling, writing and editing clinical study reports and other industry documents. It requires accurate classification of events and medications...Remote jobDocument
- MMS Holdings Inc is seeking an experienced Medical Writer based in Denver, Colorado. The role involves writing and editing clinical documents, evaluating medical literature, and mentoring team members. A strong background in regulatory writing and at least 3 years of experience...Remote jobDocument
- Parexel is seeking a Medical Writer to develop and finalize clinical documents for regulatory submissions, including study reports, protocols, and CTD overviews. You will ensure accuracy, consistency, and alignment with FDA/EMA guidelines. The role involves leading document...Remote jobDocument
- Celerion is seeking a Medical Writer to work remotely. The role analyzes and interprets safety results of clinical trials, compiles, writes and edits CSR and other industry documents, and confirms accurate classification of events using standardized coding systems. The...Remote jobDocument
- MMS Holdings Inc, based in Michigan, is seeking an experienced Medical Writer to take on critical analysis and writing responsibilities for clinical development documents. The ideal candidate will have 3-5 years of experience in regulatory writing and anticipate working...Remote jobDocument
- MMS Holdings Inc in Austin, Texas seeks a skilled Medical Writer to evaluate medical literature and write essential clinical documents. Candidates should have 3-5 years of regulatory writing experience within the pharmaceutical industry. The Medical Writer is responsible...Remote jobDocument
- MMS Holdings Inc in Baltimore, Maryland is seeking a Medical Writer to critically evaluate and write clinical documents for regulatory submissions. This role demands experience in the pharmaceutical industry and exceptional writing skills to produce high-quality documentation...Remote jobDocument
- 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 jobDocument
- Medical Writer (Consultant) - Clinical Development / Early Feasibility Study Contract-6-12+Months Seattle, WA- Remote Immediate Need Candidates residing in Europe are also encouraged to... ...Incorporate SME input and manage document versioning Ensure alignment with regulatory...Remote workDocumentContract workImmediate start
- ...research institute is seeking an experienced Source Writer with QA/QC/Regulatory expertise. You will... ...initiatives. Responsibilities include generating source documents, performing QA reviews, and ensuring compliance with clinical research regulations. The ideal candidate will...Remote jobDocument
$50 - $80 per hour
...Job Description Job Description Job Title: Medical Writer / Clinical Document Author Location: Remote Job Type: Contractor Pay: $50–$80/hour Job Overview We are seeking an experienced Medical Writer / Clinical Document Author to develop, review, and...Remote jobDocumentFor contractors- ...Medical Writer / Clinical Document Author is a remote clinical-review track for evaluating AI outputs that touch clinical review. Reviewers grade differential reasoning, dosing logic, and guideline adherence; flag patient-safety issues; and document the corrected clinical...Remote jobDocumentHourly payFor contractors10 hours per week
$116k - $128k
...Job Description: Overview The Senior Medical Writer- Clinical Focus is a major contributor to document authorship for a variety of documents across different service... ...5 years ~ Flexible, inclusive culture — 70% remote workforce, 66% women-led teams Learn more about...Remote workDocumentFull timeLocal areaWorldwideFlexible hours$124k - $170.5k
...Guided by empathy, insight, and clinical intelligence, we collaborate... ...applicant materials, some documents may still reflect legacy... ...veteran. Job Description: Medical Writer - Clinical Compliance(Solventum... .... Work location: Remote – United States Travel:...Remote workDocumentFull timeH1bWork at officeRelocation packageFlexible hours$50 - $80 per hour
...Role Overview Apply regulatory medical writing expertise to author and evaluate clinical documentation that trains and validates AI-assisted clinical writing tools.... ...Work Terms Engagement type, contractor, remote work. Work is performed on a customer project...Remote workDocumentHourly payContract workFor contractorsLocal areaSaidGig
United States6 days ago$78k - $156k
...Maple GroveJob Type: Full timeCategory: Medical and Clinical AffairsIndustry: HealthcarePosted Date... ...site opportunity for a Senior Medical Writer, Clinical Evaluation. The Sr. Medical... ...Clinical Evaluation Reporting documents for the Neuromodulation, CAHF and Vascular...DocumentWork experience placementWorldwide- ...Syneos Health is seeking a Principal / Senior Medical Writer with proven clinical document writing experience. This remote role supports global regulatory deliverables and cross-functional collaboration across study teams and clients. Ideal candidates bring extensive...Remote workDocument
Syneos Health Inc
Boston, MA3 days ago - ...Pharmaceuticals, Inc is looking for a Senior Medical Writer to join their Medical Writing team. This role involves authoring clinical documents for Global Development, emphasizing... ...regulations, and the ability to manage multiple projects from a remote location. #J-18808-Ljbffr...Remote workDocument
Regeneron Pharmaceuticals
New York, NY5 days ago - ...development and execution of medical writing strategies for clinical research projects, the full-time Senior Medical Writer will manage the... ...review of clinical study documents, collaborate with cross-functional... ...with the flexibility to work remotely or onsite. Key...Remote workDocumentFull time
Virtual Vocations Inc
United States4 days ago - ...Knowesis is seeking a Medical Writer in East Orange, NJ with remote work options to support the VA EXPRT Center. The role involves developing clinical and research documents, educational outreach, and quality assurance of materials for diverse audiences. Applicants should...Remote workDocument
Knowesis
East Orange, NJ4 days ago - ...To support clinical research initiatives, the full-time remote Medical Writer will author clinical trial and regulatory documents, engage with cross-functional teams, and ensure document quality and compliance. Key responsibilities Author clinical trial and regulatory...Remote workDocumentFull time
Virtual Vocations Inc
United States4 days ago $70 - $80 per hour
...specializing in IT is looking for a Senior Medical Writer to manage the medical writing... .... The role involves drafting clinical study protocols, regulatory documents, and managing review timelines... ...full-time position is primarily remote, with a competitive pay range of...Remote workDocumentHourly payFull timeContract workTalent Software Services
California, MO1 day ago- A clinical-stage biotechnology company is seeking a Medical Writer to lead the development of regulatory and clinical documents. The role requires expertise in medical writing and collaboration with various teams to ensure high-quality documentation. Candidates should have...Document
PepGen
Boston, MA2 days ago - ...supports the pharmaceutical, biotech, and medical device industries with a proven,... ...Under minimal supervision, the Medical Writer will critically evaluate, analyze,... ...and absence of bias Write and edit clinical development documents, including but not limited to, clinical...Remote workDocumentWorldwide
MMS Holdings
Baltimore, MD5 days ago $109k - $174.8k
...their merit. Job Function Medical Affairs Group Job Sub... ...days work from home). Remote work options may be... ...coordinate basic and complex documents, independently within... ...Write or coordinate clinical and regulatory... ...Relationships Internal: Manager, writers, and cross‑functional...Remote workDocumentFor contractorsLocal areaWork from home3 days per weekJ&J Family of Companies
Horsham, PA2 days ago$75k - $90k
...Porterhouse Medical is a global medical communications... ...strategists, medical writers, client services... ...Medical Writer – US-based (remote worker) The Medical Writer... ...for the publications/documents produced Ensuring... ...additional academic or clinical qualifications will add...Remote workDocumentWork experience placementPorterhouse Medical Group, Ltd.
New York, NY5 days ago$120k - $159k
...is hiring Senior/Principal Medical Writers (USA) to support our growing... ...in producing regulatory documentation for the international pharmaceutical... ...are integral members of clinical development teams... ...time); may work either fully remotely or a hybrid schedule (in office...Remote workDocumentLive inWork at officeWork visaTrilogy Enterprises
Durham, NC2 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Medical Writer / Clinical Document - Remote. Be the first to apply!
Related searches