Analyst II, Medical Writing, Immunology

Overview

Analyst II, Medical Writing, Immunology. This role is available in all states within the United States. Remote work options may be considered on a case-by-case basis and if approved by the Company. The role may be posted under different requisition numbers to comply with local requirements.

Responsibilities

• Writes and coordinates basic clinical documents such as, but not limited to, Phase 1 protocols, Phase 1/2 CSRs, table of studies, narratives, and initial IBs.
• Writes, contributes to, and/or coordinates low to medium complexity clinical and regulatory documents such as, but not limited to, Phase 2/3 CSRs and protocols, IB updates, summary documents, and regulatory responses under supervision.
• Performs document QC, completes lists of abbreviations, conducts literature searches, and performs other basic tasks with supervision as needed.
• Participates in and may lead cross-functional document planning and review meetings. Works in a team environment with some guidance while increasing independence for longer-term activities.
• Manages project timing, scheduling, and tracking. Interacts with cross-functional colleagues on document content and champions Medical Writing processes and best practices. Establishes document timelines and strategies in accordance with internal processes, with some mentorship from management and the clinical team as needed.
• Depending on experience level, may guide or train cross-functional team members on processes and best practices and may lead early- or late-stage compound writing teams with supervision as required.
• Learns and adheres to SOPs, templates, best practices, policies, and the Medical Writing Style Guide.
• Attends and contributes to departmental and cross-functional meetings (e.g., project kick-off, study team, Global Program Team meetings).
• Completes time reporting, training, and metrics database updates as required in relevant company systems.
• Maintains and applies knowledge of industry, company, and regulatory guidelines.

Qualifications

• Education: A university/college degree in a scientific discipline is required. An advanced degree (e.g., Masters, PhD, MD) is preferred. A minimum of 2 years of relevant pharmaceutical/scientific experience is required.
• Experience: A range of 0 to 2 years of regulatory medical writing experience is required, depending on tasks performed and level of supervision needed.
• Strong oral and written communication skills.
• Attention to detail and ability to function in a team environment.
• Excellent time management and organizational skills; ability to balance multiple tasks.
• Demonstrates learning agility and the ability to build productive cross-functional relationships.
• Gains experience in interpreting, summarizing, and presenting statistical and medical information with supervision for quality and accuracy of content.
• Emerging leadership skills in project and process management, time management, influencing, negotiating, and taking initiative; resolves basic problems independently and more complex problems with supervision.
• Develops and applies knowledge of regulatory guidance documents such as ICH requirements.