Lead Medical Writer, Regulatory Submissions | Remote
ICON Strategic Solutions
A leading healthcare intelligence firm is seeking a Principal Medical Writer to lead the development of regulatory and clinical documents. The ideal candidate will have an advanced degree in life sciences and significant medical writing experience, particularly in regulatory submissions. This role offers a competitive salary and a variety of benefits including health insurance and flexible plans to promote work-life balance. #J-18808-Ljbffr
$130k - $150k
Praxis Precision Medicines, Inc. is seeking a talented Medical Writer to oversee documents for clinical development programs. This role requires... ...degree in a scientific discipline. Responsibilities include leading the preparation of clinical trial documents and collaborating...Remote jobRegulatoryFlexible hours- ...A leading biopharmaceutical company is looking for a Senior Medical Writer to develop clinical documents for regulatory submissions. The candidate will manage medical writing projects, lead timelines, and collaborate with cross-functional teams. Key qualifications include...Remote workRegulatory
$128k - $176k
...A leading biotech company is looking for a Senior Medical Writer to provide support for developing complex clinical and regulatory documents. The ideal candidate will have a degree in a scientific... ...managing content for regulatory submissions and ensuring quality standards...Remote workRegulatory- .../f/x) to support our Medical Writing activities in... ...connection with a NDA submission. This assignment can... ...pharmacology experts as lead medical writer Provide project... ...assignment can be done remotely from the EU, UK or US... ...substantial medical / regulatory writing experience in...Remote jobRegulatory
- 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
- 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
$160k - $175k
...cancer and beyond. Our lead program, palazestrant... ...Role >>> Lead Senior Medical Writer As the Lead Senior Medical... ...scientific and regulatory documents supporting Olema... ...for regulatory submissions, medical communications... ...Experience working in hybrid/remote environments...Remote workRegulatoryWork at officeFlexible hours- ...A leading life sciences company is seeking a Regulatory Operations Manager to oversee the publishing of deliverables for electronic submissions to health authorities. The role involves vendor oversight... ...the US and Europe. This is a remote position requiring expertise in...Remote workRegulatory
- ...Medicines, Inc. is searching for a Senior Regulatory Submissions Manager to oversee regulatory... ...teams. Benefits include comprehensive medical coverage, 401(k) match, stock incentives... ...generous PTO. This position offers a remote work option with travel as needed. #J-...Remote workRegulatory
- ...A biopharmaceutical solutions organization is seeking a Sr Medical Writer to manage and lead medical writing deliverables for clinical studies. The successful candidate will ensure regulatory compliance, mentor junior writers, and maintain relationships with clients....Remote workRegulatory
$89k - $148k
...A leading healthcare company is seeking an experienced medical writer to lead projects for Clinical Research Scientists and other... ...complex research into regulatory documents and mentoring team members... ...plus bonuses, with the potential for remote work. #J-18808-Ljbffr...Remote workRegulatory$128k - $156k
Disc Medicine in Watertown, MA, is seeking a Regulatory Operations Manager to manage regulatory submissions and document compliance activities. This full-time role requires 5-7 years of direct experience and expertise in MS Word and Veeva RIM. Responsibilities include...Remote jobRegulatoryFull time- ...seeking a Senior Specialist for Regulatory Operations to manage regulatory submissions and support systems in Frederick,... ...standards. Responsibilities include leading submissions, working with vendors... ...management. Benefits include medical insurance, 401k with a company match...Remote jobRegulatory
$130k - $160k
A leading diagnostics firm is seeking a Manager, Medical Writing, responsible for overseeing the... ...ensuring high-quality regulatory documents for market submissions. The role includes mentoring writers, managing deadlines,... ...The position is fully remote, offering a compensation...Remote jobRegulatory$70k - $130k
...company is seeking a Senior Specialist in Regulatory Operations to manage regulatory submissions across their development pipeline. The role involves leading submission management and ensuring... ...field. The position can be remote or based at the company's office in...Remote jobRegulatoryWork at office$113k - $142.43k
A leading biopharmaceutical company seeks a Senior Regulatory Medical Writer to lead the preparation of clinical regulatory documents. This role involves collaboration with... ...strong analytical and time-management skills. Remote work may be available, although preference is...Remote jobRegulatory$130.8k - $209.4k
...alignment with program goals, regulatory expectations, and business... ...stability sections for regulatory submissions, responses, and technical... ...and expiry‑related planning. Lead or support investigations for... ...presence at the Moderna site. Remote work is not eligible....Remote workRegulatoryPermanent employmentFull time- A leading clinical research organization is seeking a Nonclinical Writer to develop and write regulatory documents. The role involves collaborating with cross-functional teams and ensuring... ...with GLP and ICH guidelines are essential for this remote position. #J-18808-LjbffrRemote workRegulatory
- ...Associates is looking for an experienced Regulatory Affairs Consultant to provide regulatory... ...regulatory pathways, especially in IVD medical devices and AST diagnostics. This role involves... ...manufacturers. The position allows for remote work with travel as required, and offers...Remote workRegulatoryContract work
- ...A clinical research organization is seeking a Regulatory Writer to manage and develop technical nonclinical documents. This full-time, remote position requires at least 2 years of writing experience in the pharmaceutical industry, strong analytical skills, and proficiency...Remote workRegulatoryFull 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 workRegulatory$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 workRegulatory- ...Create responses for audit/submission queries. Maintain a database... ...maintain plans and reports for regulatory authorities. Review/... ...Deep knowledge of EU MDR and Medical Writing from CER, CEP, PMCF Plan... ...Colorado, or any site in MN, or remote. No requirement to be on site...Remote workRegulatoryFull timePart time
- ...Overview Senior Medical Writer (Remote) at MMS. Join to apply for the Senior Medical Writer (Remote... ...approach to complex trial data and regulatory submission challenges. With a global footprint... ...with clinical study protocols as lead author. Experience leading and managing...Remote workRegulatoryFull time
- ...Senior Medical Writer About the Role We are seeking... ...-III clinical studies and regulatory documentation . This role focuses... ...Support regulatory submissions: eCTD Module 2 & Module... ...Functional Collaboration Lead document planning and...Remote workRegulatory
- ...Principal Medical Writer - Regulatory And Medical Writing Headquartered in Carlsbad... ...marketed medicines and a leading pipeline in neurology,... ...making our onsite, hybrid and remote work environments a place where... ...for publishing and submission. The Principal Medical Writer...Remote workRegulatoryWork at office
- ...Senior Medical Writer The remote Senior Medical Writer is responsible for providing clinical regulatory document support to the clinical teams, ensuring... ...of high-quality submission-ready documents and effective... ...Serves as medical writing lead on clinical regulatory...Remote workRegulatory
- ...Medical Writer - India Praxis is seeking a Medical Writer... ..., high quality, and regulatory compliant documents in... ...trials and regulatory submissions. This requires the knowledge... ...This position will be remote and located in India.... ..., serving as writing lead on assigned documents...Remote workRegulatoryLocal areaWorldwide
- ...Overview Principal Medical Writer job at ICON Strategic Solutions. Remote. ICON plc is a world-leading healthcare intelligence and clinical... ...of high-quality regulatory and clinical documents that... ...in supporting our clients' submissions to regulatory authorities and...Remote workRegulatoryFlexible hours
- ...Clinical Research Medical Writers Snr Manager And Principal Level Medical Writers The... ...Each will be an active contributor/lead author of regulatory and scientific documentation, will manage... ...’s brochures, and regulatory submissions. Will coordinate the efforts of cross...Remote workRegulatoryContract workFlexible hours
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