Remote Regulatory Medical Writer for FDA Submissions
$30 - $100 per hourCrossing Hurdles
- Remote job
A regulatory consultancy is seeking a Regulatory Medical Writer to develop structured prompts and review critical documentation for FDA submissions. The ideal candidate should have proven experience in preparing regulatory documents, deep knowledge of FDA and ICH guidelines, and strong communication skills. This remote position offers flexible hours, requiring a commitment of 10 to 40 hours per week, with compensation ranging between $30 and $100 per hour. #J-18808-Ljbffr Crossing Hurdles
- ...healthcare intelligence firm is seeking a Principal Medical Writer to lead the development of regulatory and clinical documents. The ideal candidate will... ...medical writing experience, particularly in regulatory submissions. This role offers a competitive salary and a...Remote jobRegulatoryFlexible hours
- A leading data-focused CRO is seeking a Remote Senior Medical Writer to contribute to clinical development documents and mentor team members. Candidates should have strong writing skills, at least three years of experience in the pharmaceutical industry, and an educational...Remote jobRegulatoryFull time
$130k - $150k
...stage biopharmaceutical firm is seeking a Medical Writer to support clinical development... ...responsible for producing high-quality regulatory documents and collaborating with cross-... ...range of $130,000 - $150,000 USD annually, remote work flexibility, and a comprehensive benefits...Remote jobRegulatory$130k - $150k
Praxis Precision Medicines, Inc. is seeking a talented Medical Writer to oversee documents for clinical development programs. This role requires at least 4 years of medical writing experience in a Sponsor or CRO setting, along with a Bachelor’s degree in a scientific discipline...Remote jobRegulatoryFlexible hours- A biopharmaceutical company seeks a Regulatory Medical Writer in Los Angeles, CA. This role involves preparing, reviewing, and editing regulatory documents for submission to the FDA, ensuring compliance with guidelines. Required qualifications include a Bachelor’s degree...Regulatory
- ...Kaiva Tech, LLC is seeking a Medical Editor in the DC Metro... ...Workplace Type : Currently 100% remote. Please be aware that the... ...and Drug Administration (FDA) who regulate gene therapy,... ...tables using data derived from regulatory submissions to the FDA. The position requires...Remote workRegulatoryWork experience placement
- argenx SE is seeking a Senior Medical Writer to author and manage contributions for regulatory submissions, ensuring compliance with medical writing standards. The successful candidate will have a strong background in pharma or biotech, with at least 3 years of clinical...Regulatory
- ...Director or Associate Director of Regulatory Affairs to oversee regulatory strategies and submissions for pharmaceutical products.... ...pivotal role involves ensuring FDA compliance and guiding products... ...submissions. This position is remote eligible for candidates in the...Remote workRegulatory
- Dexian is seeking a remote Clinical Medical Writer to support the timely development of clinical documentation. The role involves assisting... ...experience in clinical writing, a solid understanding of regulatory submission processes, and the ability to work independently. #J-...Remote jobRegulatoryContract work
$42 - $45 per hour
Dexian DISYS is seeking a Clinical/Medical Writer for a remote role with a contract duration of 6 months. The ideal candidate will assist... ...reports and technical documents, overseeing the electronic regulatory submission process. This position requires at least 4 years of...Remote jobRegulatoryContract work$145k - $155k
Terumo Group is seeking a Sr. Medical Writer for a remote role in Los Angeles. This position involves collaborating with clinical and regulatory teams to produce a range of medical documents for regulatory submissions, including clinical evaluation reports and study protocols...Remote jobRegulatory$42 - $45 per hour
Dexian is seeking a Clinical/Medical Writer for a remote position with a 6-month contract. This role involves developing clinical reports, overseeing regulatory submissions, and ensuring timely completion of documentation. The ideal candidate should possess a college degree...Remote jobRegulatoryHourly payContract work- ...development of clinical documentation, the remote Clinical Medical Writer will assist in creating clinical reports,... ...development and completion of clinical reports and regulatory documentation Oversee the electronic regulatory submission process and provide recommendations for...Remote workRegulatoryContract work
$145k - $155k
Sr. Medical Writer Peripheral Vascular Med Device (U.S. Remote) Position Overview This is a Temp-To-Hire Position Primary contact... ...Collaborating with the clinical & regulatory teams to write clinical documents for regulatory submissions, including but not limited to:...Remote jobRegulatoryTemporary workInterim role- ...a PLG company, is looking for an experienced Regulatory Medical Writer to support NDA submission programs. This fully remote consulting position requires expertise in authoring... ...Module 5 documents, with a strong focus on FDA submission processes. Ideal candidates will...Remote jobRegulatory
- ...supports the pharmaceutical, biotech, and medical device industries with a proven,... ...scientific approach to complex trial data and regulatory submission challenges. With a global footprint... ...minimal supervision, the Medical Writer will critically evaluate, analyze, and...Remote jobRegulatoryWorldwide
- ...leading pharmaceutical company is hiring a Sr. Regulatory Specialist for a fully remote position. This role requires a Ph.D. in Biomedical... ...R&D teams, shape study designs, and prepare submission-ready documentation for FDA submissions. Strong scientific writing and communication...Remote jobRegulatoryFlexible hours
- Medical Writer II job at US Tech Solutions. Remote. Location: Remote. Duration: 12 months contract. Job Description... ...Maintain strong knowledge of clinical regulatory documents requiring quality... ...and international regulatory submissions. Incorporates text, graphs, charts...Remote jobRegulatoryContract work
- ...divh2Principal Medical Writer - Regulatory And Medical Writing/h2pHeadquartered in... ...making our onsite, hybrid and remote work environments a place... ...for publishing and submission. The Principal Medical Writer... ...working knowledge of relevant FDA, EMA, and ICH guidelines, particularly...Remote workRegulatoryWork at office
- ...pharmaceutical industry, is seeking a Medical Writer II to join their team. As a... ...Medical Writer II Location Remote Pay Range $55.00-$62.00/... ...Documents (VDRs) and other submission-related materials Create... ...Support development of regulatory content aligned with internal...Remote workRegulatoryWeekly payTemporary workFlexible hours
- ...domain expertise in regulatory sciences, clinical... ..., medical information, and R... ...NDA, BLA, MAA, eCTD submission level documents) as... ...experienced medical writers, as necessary.... ...understanding of FDA (and other regulatory... ...ProPharma supports remote working, we also recognize...Remote workRegulatoryContract workWork at office
$100k - $160k
...the job Market Access Medical Writer Senior Medical Writer... ...Market Access Strategy Remote Position (EST Hours) Join... ..., and compliant with regulatory guidelines. Guide... ...medical/regulatory approval submissions , incorporating client... ...on industry trends, FDA regulations, and best...Remote workRegulatoryFlexible hours- TechData Service is seeking a Medical Writer with an advanced degree and 3-5 years of experience in medical writing... ...will have a strong background in writing regulatory documents for clinical trials and submissions, and must be able to simplify complex scientific...Regulatory
$119.3k - $159.3k
BeiGene, Ltd. is seeking a Regulatory Writer to join its dynamic team in the United States. This role involves developing high-quality clinical and regulatory documents to ensure timely submissions of products. You will also mentor junior writers, ensuring compliance with...Regulatory- Itlearn360 is seeking a Senior Medical Writer in South San Francisco. This role involves overseeing high-quality documents for clinical trials and regulatory submissions. The ideal candidate should have 8-10 years of scientific writing experience, including expertise in...Remote jobRegulatoryHourly payTemporary work
- Lead of Medical Writer Location: Beijing-CN Responsibilities Lead the Medical Writing team... ...Bristol Myers Squibb (BMS) China Regulatory Affairs. Ensure delivery of high-quality... ...documents. Support streamlined, compliant submissions to NMPA and global health authorities,...Regulatory
- A leading staffing firm is seeking a Medical Author to document clinical data and regulatory submissions to support drug development. This role requires expertise in analytical writing, project management, and collaboration with product teams to ensure high-quality deliverables...Regulatory
- Medical Writer job at Getinge. Wayne, NJ. With a passion for life Join our diverse... ...quality study documentation that is submission-ready for various regulatory agency and external distribution.... ...annual with 10% STIP #LI-YA2 #LI-Remote About us With a firm belief that every...Remote workRegulatoryTemporary workWork at officeWorldwideFlexible hours
- Medical/Technical Writer, Scientific Research Location: Cincinnati, OH / Remote Hybrid We are seeking a skilled Medical/Technical Writer... ..., clinical, medical) and regulatory documentation efforts. The... ...scientific documents and regulatory submissions. Familiarity with the...Remote workRegulatoryFull time2 days per week1 day per week
- ...organization, is seeking an experienced Regulatory Medical Writer to support NDA submission programs for our growing portfolio... ...expertise authoring and compiling FDA New Drug Application (NDA)... ...NDA submission programs. Working remotely within a collaborative consulting...Remote workRegulatory
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