Medical Writer

Job Title :

Medical Writer Location :

100% Remote Contract length : 3 months

Schedule :

40 hrs/week

Pay :

$75/hr to $80/hr,

DOE Medical Writer Job Overview:

We are seeking a skilled Medical Writer to develop high-quality clinical and regulatory documents in compliance with industry standards and regulatory guidelines. The ideal candidate will collaborate with cross-functional teams, including Clinical, Regulatory, Biostatistics, and Medical Affairs, to create well-structured, scientifically accurate, and regulatory-compliant documents.

Job Responsibilities:

Regulatory Document Writing:

Prepare and author clinical and regulatory documents, including but not limited to: Clinical Study Protocols (CSPs) and Protocol Amendments Clinical Study Reports (CSRs) Investigator's Brochures (IBs) Informed Consent Forms (ICFs) Common Technical Document (CTD) Modules (e.g., Module 2.5 Clinical Overview, Module 2.7 Clinical Summary) Briefing Documents for Regulatory Authorities (e.g., FDA, EMA) Periodic Safety Reports Risk Management Plans (RMPs) and Pediatric Investigation Plans (PIPs) New Drug Applications (NDAs), Biologics License Applications (BLAs), and Marketing Authorization Applications (MAAs) Responses to regulatory queries

Clinical Development Support:

Develop and maintain clinical development plans, clinical trial protocols, and statistical analysis plans Collaborate with clinical teams to ensure alignment of clinical documents with study objectives and regulatory requirements Interpret complex scientific and clinical data and communicate findings clearly and concisely

Regulatory Compliance & Standards:

Ensure documents comply with ICH, GCP, FDA, EMA, and other applicable regulatory agency guidelines Maintain up-to-date knowledge of regulatory writing best practices, industry trends, and evolving guidelines

Collaboration & Review:

Work closely with cross-functional teams, including medical, clinical, regulatory, statistical, and quality assurance teams Review and edit documents prepared by internal teams or external vendors to ensure scientific accuracy, clarity, and compliance Participate in team meetings, regulatory interactions, and strategy discussions Drive document production timelines according to established plans Plan and manage multiple simultaneous document development projects with shifting priorities

Job Qualifications:

Advanced degree (PhD, PharmD, MD, or MSc) in Life Sciences, Medicine, Pharmacy, or a related field Minimum 3-5 years of medical writing experience in the pharmaceutical, biotech, or CRO industry Strong background in writing regulatory documents for clinical trials and submissions Epilepsy or Neurology experience is a plus Experience with drug development across different phases (Phase I-IV) is a plus Strong understanding of the drug development process, clinical research concepts, clinical study conduct, clinical study data collection, regulatory requirements, and biostatistical concepts Familiarity with medical terminology and ability to interpret complex clinical data Strong understanding of the concepts of coding dictionaries (MedDRA, WHODrug, etc.) Excellent scientific writing, editing, and document structuring skills Ability to simplify complex scientific concepts for diverse audiences Proficiency in ICH guidelines, GCP, and regulatory submission requirements (FDA, EMA, etc.) Strong attention to detail, ability to manage multiple projects, and meet deadlines Ability to work independently and collaboratively in a fast-paced environment High level of Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) Experience with document management systems and publishing tools (e.g., EndNote, Adobe Acrobat, regulatory submission platforms) Veeva experience