Principal Medical Writer-nonclinical focus

Key Purpose

The Principal Medical Writer independently plans and prepares a range of regulatory documents and medical communications to support all phases of product development. The primary responsibilities of the position are organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with International Council for Harmonization (ICH) and other regulatory guidelines, and individual company document standards.

Primary Duties & Responsibilities

• Work closely with client and internal and partner organization teams to lead development of strategies for organizing and preparing regulatory documents
• Lead a project team, and actively participate in development and writing of high-quality documents (study-level and submission level documents, pharmacovigilance documents)
• Author documents per client specifications, templates, style guides, and other guidance documents
• Author documents per regulatory authority guidelines and requirements
• Act as client advisor, working collaboratively and developing a strong relationship of trust built upon consistent and reliable communication; communicate ideas and strategies to produce a successful end result
• PRACTICE BLAMELESS PROBLEM SOLVING, taking broad perspectives in resolving issues to prevent negative impact to work
• Manage budget for a low complexity project, including all contributors (writers, editors)
• Usher documents through the review process, conduct comment resolutions meetings (CRMs) and successfully lead a project team to consensus
• Maintain collaborative, proactive, and effective communication with both clients and internal teams
• Lead project-related meetings and teleconferences
• Provide coaching to junior staff for study level documents as well as submission level documents and ensure all staff comply with company standard operating procedures (SOPs) and training requirements