Remote Regulatory Medical Writer - NDA Module 2 & 5 Expert
DSI - DS InPharmatics, a PLG company
- Remote job
DSI - DS InPharmatics, 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 and compiling NDA Module 2 and Module 5 documents, with a strong focus on FDA submission processes. Ideal candidates will have 8–10 years of experience in pharmaceutical or biotechnology writing, preferably with both small molecule and biologic programs. This high-impact role offers flexibility and the opportunity to contribute to significant regulatory drug development initiatives. #J-18808-Ljbffr DSI - DS InPharmatics, a PLG company
$70 - $80 per hour
...0/hr - $80.00/hr Sr. Medical Writer Job Summary: Talent Software... ...position in CA (Remote). The opportunity will... ...in the preparation of regulatory filings (eg, briefing books, eCTD Module 2/Module 5 clinical or integrated... ...standard eCTD IND/NDA work, including: Modules...Remote workRegulatoryPermanent employmentFull timeContract workFor contractorsWork at officeShift work- ...seeking an experienced Regulatory Medical Writer to support NDA submission programs for... ...submissions, specifically NDA Module 2 and Module 5 content in CTD/eCTD... ...Medical Writer will provide expert-level authoring and... ...submission programs. Working remotely within a collaborative...Remote workRegulatory
- A global medical device consulting firm is looking for a EUMDR Medical Writer for a remote, full-time engagement. Candidates should have a minimum of 5 years of medical or scientific writing experience... ...reviews, and compliance with regulatory guidelines. Strong written...Remote jobRegulatoryFull time
- ...clients to develop medically accurate,... ...growth. Medical Writer / Copywriter| Boutique... ...days in office / 2 days remote) Benefits: Health... ...engaging training module, tightening a set... ...schedule of 5 workdays per week... ...processes (MLR, med-legal-regulatory, or similar)....Remote workRegulatoryFull timeContract workPart timeFreelanceWork at officeWork from home2 days per week
- A leading regulatory consultancy seeks a highly experienced Regulatory Consultant to guide strategy and manage 505(b)(2) NDA submissions. The role requires at least 10 years of experience in... ...strategy development. This fully remote position is ideal for individuals with...Remote workRegulatory
- ...divh2Principal Medical Writer - Regulatory And Medical Writing/h2pHeadquartered... ...onsite, hybrid and remote work environments a... ...Application Module 2 summary documents),... ...Function as subject matter expert within the department... ...writer of Module 2.5, 2.7.3, or 2.7.4) required...Remote workRegulatoryWork at office
- ...pharmaceutical, biotech, and medical device industries... ...trial data and regulatory submission... ...supervision, the Medical Writer will critically... ...efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation... ...documents. Have expert proficiency with...Remote jobRegulatoryWorldwide
- ...Application Subject Matter Expert Job Title:... ...Matter Expert Remote role - Ideal... ...banking clients. #2. Client Consultation... ...for clients. #5. Training and Knowledge... ...technologies, and regulatory changes in the... ...Systems and related modules. Proven...Remote workRegulatoryFull timeLive in
$100.71k - $110.42k
Job Summary The Regulatory Specialist reports... ...as well as share expert knowledge of complex... ...U.S. and abroad (5%). Prepare and file... ...including A/NDA’s, Supplements, Amendments... ...days per week and 2 days per week remote. Requirements... ...package including medical, dental and vision...Remote jobRegulatoryWork at office2 days per week3 days per week$119.3k - $159.3k
...a key member of the regulatory writing team, you will... ...documents, and IND, NDA, BLA, and MAA modules—facilitating the timely... ...also mentor junior medical writers (full‑time employees... ...Bachelor’s degree with 5+ years of regulatory... ...; PhD/PharmD/MD with 2+ years. Computer Skills...RegulatoryFull timeFor contractors- ...Description Title: Sr. Medical Writer Duration: 2 years Location:... ...Communications group. Remote candidates are an option... ...and reviewing regulatory documents and responses... ...and corporate goals Expert knowledge of clinical... ...is preferred PHD with 5+ years of experience...Remote workRegulatoryWork at officeLocal areaRelocation
- Medical Writer job at Getinge. Wayne, NJ. With a passion for... ...in accordance to MEDDEV 2.7/1 Revision 4 and in... ...submission-ready for various regulatory agency and external... ...submission. (5%) Write and/or contribute... ...with 10% STIP #LI-YA2 #LI-Remote About us With a firm belief...Remote workRegulatoryTemporary workWork at officeWorldwideFlexible hours
€58k - €78k per year
...Cybersecurity GRC & AI Governance Expert We are seeking a... ...to join our fully remote Cybersecurity GRC team.... ...frameworks (ISO 27001, SOC 2) alongside a practical... ...with the ISO/IEC 42001 Regulatory Compliance: In... ...Qualifications Experience: 5+ years in Cybersecurity...Remote workRegulatory- ...language. As a Subject Matter Expert, you will create and... ...for accuracy, regulatory alignment, and professional... ...English proficiency ~5+ years of experience in... ...expertise in the domain Step 2: Register in Tipalti... ...physical or mental disability, medical condition, genetic...Remote workRegulatoryFor contractorsLocal area
- .... The Subject Matter Expert (SME) for Dispute Resolution... ...leakage, and ensure regulatory compliance in an increasingly... ...~ Minimum of 5 years of hands-on experience... ...related regulatory space ~2 years of experience... ...Location Open to remote or in-office position (New...Remote workRegulatoryFull timeWork at officeShift work
$21.6 per hour
...Portuguese Subject Matter Experts (SMEs) in Fandoms to... ...Freelance Location: Brazil (Remote) - Open to candidates in... ...Duration: Approx. 2 months We offer paid... ...cultural, social, and regulatory context where relevant... ...Brazilian Portuguese (pt-BR) ~5–10+ years of...Remote workRegulatoryPart timeFreelance10 hours per weekFlexible hours- ...environments. As a Subject Matter Expert, you will create and... ...English proficiency 5+ years of professional... ...Work, Compliance & Regulatory Affairs, Police or Public... ...in the domain. Step 2: Register in Tipalti to... ...physical or mental disability, medical condition, genetic...Remote workRegulatoryFor contractorsLocal area
- ...region. As a Subject Matter Expert, you will help create... ...generated responses for medical correctness, operational... ...hospital workflows and regulatory expectations Qualifications... ...proficiency ~5+ years of professional... ...expertise in the domain. Step 2: Register in Tipalti...Remote workRegulatoryFor contractorsLocal area
- ...environments. As a Subject Matter Expert, you will create and... ...proficiency ~5+ years of professional... ...professional service workflows, regulatory and compliance... ...expertise in the domain. Step 2: Register in Tipalti to... ...or mental disability, medical condition, genetic characteristics...Remote workRegulatoryFor contractorsLocal area
- ...environments. As a Subject Matter Expert, you will create and... ...English proficiency ~5+ years of professional... ...service workflows, regulatory and compliance requirements... ...in the domain. Step 2: Register in Tipalti to... ...physical or mental disability, medical condition, genetic...Remote workRegulatoryFor contractorsLocal area
- ...AWS Cloud Subject Matter Expert, Greenville, SC We... ...requirements and other regulatory and cybersecurity frameworks... ...costs. This is mainly remote, but candidates must live... ...Expert will bring at least 5 years of overall... ...including a minimum of 2 years working in cloud...Remote workRegulatoryFor contractorsLive inWork at officeWork from homeMonday to FridayFlexible hoursWeekend work
- ...Title: Hardware Security Modules Engineer Location:... ...AZ / Omaha, NE (Onsite 5 Days) Duration: Contract... ...security policies, and regulatory requirements. Key... ...Manage HSM partitioning, remote HSM administration and auditing... ...standards: FIPS 140-2/140-3, NIST SP 800...Remote workRegulatoryContract work
$36 per hour
...Portuguese Subject Matter Experts (SMEs) in Politics (... ...Freelance Location: Brazil (Remote) - Open to candidates in... ...Duration: Approx. 2 months We offer paid... ...cultural, social, and regulatory context where relevant... ...relevant field (required) ~5–10+ years of...Remote workRegulatoryPart timeFreelance10 hours per weekFlexible hoursShift work- ...Response Team (CERT) Subject Matter Expert (SME) Bottom Line Up Front:... ...‑based activities. Location: Remote support (CONUS) and forward... ...international and regulatory considerations Interpersonal,... ...actionable instructional content. 2 - 5 years experience with executing...Remote workRegulatoryPart timeImmediate start
- ...always fit into a 9-to-5 schedule. We offer... ...effectively. Remote Work: Niyam... ...Maximo Subject Matter Expert (SME) to lead the design... ...projects requiring regulatory compliance in asset... ...for a minimum of 2 business days or until... ...military status, medical condition, genetic...Remote workRegulatoryLocal areaFlexible hours
- ...Real Estate Counsel (Leasing expert) for Top Financial Company Location: Fully Remote Engagement Type: Full-Time Project (1-2 Year Duration) About the... ...business goals and regulatory requirements. Lease Portfolio... ...membership required. Minimum 5 years of experience in...Remote workRegulatoryFull timeContract workTemporary workWork at office
- ...always fit into a 9-to-5 schedule. We offer... ...effectively. Remote Work : Niyam... ...Maximo Subject Matter Expert (SME) to lead the design... ...management, and regulatory compliance. Understanding... ...for a minimum of 2 business days or... ...military status, medical condition, genetic...Remote workRegulatoryLocal areaFlexible hours
$145k - $205k
...Marketplace policy and regulatory knowledge. Key Tasks... ...affecting MSD scope Provide expert guidance on QHP... ...management Support Tier 2 and Tier 3 escalation resolution... ...Experience Minimum 5 years of direct... ...Administrative Notes, etc.) Remote / Telework with...Remote workRegulatoryContract workFor contractorsCasual workLocal areaFlexible hours- ...per policy • Maintains patient medical record regarding thinning,... ...hospital policy procedure and regulatory guidelines. • Accepts responsibility... ...in terms of patient needs; 2) knowledge of growth and development... ...department and institution. 5. Perform work in a cost...RegulatoryShift work
- TechData Service is seeking a Medical Writer with an advanced degree and 3-5 years of experience in medical writing. The ideal candidate will have a strong background in writing regulatory documents for clinical trials and submissions, and must be able to simplify complex...Regulatory
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