Medical Writer (Nonclinical and Clinical)

San Diego, CA

  • We are seeking a responsible, dynamic, creative and highly motivated Medical Writer to join our Regulatory Writing team.
  • The Medical Writer is responsible for writing, reviewing, and overseeing the production of nonclinical and clinical documents in support of drug development programs.

Specific Responsibilities

  • Working directly to support the nonclinical and clinical teams by authoring or editing/formatting documents and managing the document review process
  • Participating in IND and clinical study teams to provide input regarding deliverables, timelines, and process
  • Coordinating with project team and functional area leads regarding appropriate document content
  • Documents include but are not limited to: nonclinical documents including pharmacology, PK, and toxicology summary reports, clinical protocols and protocol amendments, clinical study reports, investigator brochures, and annual reports

Requirements

  • Qualifications: Bachelor's degree in life sciences, RN, Master's degree in life sciences, PharmD or PhD preferred
  • 1-3 years of regulatory medical writing experience in the biotech or pharmaceutical industry
  • The medical writer should be familiar with FDA and ICH guidelines and the current AMA Style Manual
  • Experience with regulatory submissions (IND, NDA) in eCTD format
  • Experience authoring/editing nonclinical and clinical study documents
  • Excellent written and oral communication and interpretive skills
  • High attention to detail, and excellent proofreading and editing skills
  • High‑level competence in pertinent software (e.g., Word, PowerPoint, EndNote)
  • Knowledge of the drug development process and general knowledge of applied clinical medicine and laboratory interpretation
  • Experience with small molecule drug development is preferred
  • Demonstrated ability in project management, with overlapping priorities and aggressive timelines

Please submit your resume or additional inquiries to apply@biosplice.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.