Sr Scientific Writing Specialist

Role: Senior Scientific Writing Specialist responsible for drafting and managing review processes for Clinical Bioanalysis and Clinical Pharmacology submission documents across multiple therapeutic areas (Cardiovascular & Metabolism, Oncology, General Medicine, Immunology & Inflammation, Genetic Medicine) and all phases of clinical development (Phase 1-3). Responsibilities: independently produce reports and summaries, lead document meetings, reconcile comments, participate in cross-functional program meetings, manage multiple projects and timelines, review data for consistency, and contribute to document templates. Qualifications: BS with 2+ years relevant experience or MS/PhD/PharmD in life sciences, 1-2 years industry experience in biotech/pharma; strong attention to detail, excellent communication, and proficiency in standard software. Preferred: experience with digital tech solutions (e.g., AI tools), basic understanding of eCTD and drug development processes, and background in protein therapeutics and gene therapy. HighValue: involvement in clinical bioanalytical and pharmacological documentation, supporting submissions in multiple phases, and working within a fast-paced, cross-disciplinary environment. WorkSetup: location unspecified; work model/flexibility not detailed; digital technology engagement encouraged.