Medical Writer, Disclosure

Responsibilities: - Acquire and apply medical writing knowledge across design, planning, authoring, editing, and review of accurate, clear, high-quality documents using best practices (e.g., lean writing, health literacy).

• Prepare clinical regulatory and/or public-facing documents per company and evolving regulatory requirements (e.g., clinical study reports, participant narratives, investigator’s brochures; trial registrations/results postings, plain language summaries, informed consent forms).
• Contribute on cross-functional, document-specific teams; collaborate and negotiate with internal/external stakeholders; plan, author, and lead documents through review and final approval.
• Identify and propose solutions to challenges across scope (documents, content, processes, timelines, tools); keep Project Leads/management informed and elevate issues impacting timelines, quality, or compliance.
• Apply developing knowledge of clinical development, regulations, disease areas, and company products.
• Apply developing knowledge of medical writing tools and technology platforms.
• Participate in initiatives to improve medical writing processes and standards.

Qualifications: - Required: Bachelor’s degree (health, scientific, or relevant discipline) and at least 2 years of relevant industry experience. Required Skills/Experience: - Knowledge of clinical research principles, clinical trial design, and fundamental statistics.

• Strong attention to detail; analytical/logical thinking; ability to evaluate/interpret data; problem-solving.
• Ability to manage multiple deadline-driven projects independently and collaboratively.
• Strong oral/written communication, interpersonal, and presentation skills.
• Technical expertise in office applications (e.g., Microsoft Office) and shared document systems (e.g., SharePoint); willingness to learn emerging technology.

Preferred Skills/Experience: - Familiarity with US and/or EU legislation for clinical trial registration/results disclosure and clinical research documents. - Technical/medical authoring experience with clinical regulatory documents (e.g., clinical study reports, protocols), public registry registrations/results disclosures, and/or medical publications or regulatory labeling. #J-18808-Ljbffr Scorpion Therapeutics