Medical Writer

USDM Life Sciences is a global consulting company supporting regulated biotech, medical device, and pharmaceutical organizations with GxP technology and transformation. The Medical Writer develops high-quality clinical and regulatory documents that meet ICH/GCP and agency (FDA/EMA) requirements. The role partners with cross-functional stakeholders to produce scientifically accurate, submission-ready documentation across the drug development lifecycle.

• Author and prepare clinical and regulatory documents (e.g., CSPs and amendments, CSRs, IBs, ICFs, CTD modules such as 2.5/2.7, briefing documents, periodic safety reports, RMPs, PIPs, NDAs/BLAs/MAAs, and responses to regulatory queries).
• Develop and maintain clinical development plans, clinical trial protocols, and statistical analysis plans in collaboration with clinical stakeholders.
• Interpret complex scientific/clinical data and communicate conclusions clearly and concisely for diverse audiences.
• Ensure documentation complies with ICH, GCP, FDA, EMA, and other relevant regulatory standards; stay current on evolving guidance and best practices.
• Collaborate with medical, clinical, regulatory, biostatistics, medical affairs, and quality teams to align documents with study objectives and regulatory requirements.
• Review and edit documents created by internal teams and external vendors for scientific accuracy, clarity, consistency, and compliance.
• Participate in team meetings, regulatory interactions, and strategy discussions; drive document timelines and manage multiple concurrent projects with shifting priorities.
• Perform other related duties and assignments as required.

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

• Compensation range: USD 54.00–64.00 per hour (W2); estimated monthly equivalent based on 40 hours/week is approximately USD 9,360–11,093.
• Work environment: environmentally controlled home office; prolonged sitting/standing and extensive computer work; frequent communication via phone/email/IM; may use office equipment such as scanner/printer.
• Benefits (full-time): health, vision, dental, life insurance, short- and long-term disability, hospital indemnity, accident, and critical care coverage.
• Retirement: 401(k) eligibility for employees age 21+ (full-time and part-time).
• Paid time off: may be available for eligible employees.
• Additional: rewards and recognition program.