Principal Medical Writer(m/w/x)

Requirements

• Life Science Master's degree or PhD
• 8-10 years' regulatory medical writing experience, scientific/regulatory knowledge, in-depth process knowledge
• Experience leading complex global regulatory/clinical writing projects (CSRs, CTDs, ODDs, PIPs, briefing documents, regulatory responses)
• Experience leading writing for major US/EMA regulatory submissions, coordinating Medical Writers
• Clear understanding of clinical development (phases, processes, techniques from protocol design to regulatory submission and product support)
• Advanced knowledge of global regulatory environment and processes
• Excellent written and spoken English skills
• Highly developed analytical and strategic thinking, key issue identification
• Clear and effective communication of complex ideas to stakeholders
• Strong interpersonal, communication, influencing skills, ability to coordinate others
• Strong teamwork, ability to drive/manage team performance, cross-cultural collaboration
• Result-orientation, excellent problem-solving skills, flexible attitude
• Ability to manage multiple parallel tasks, prioritize under time pressure
• Strong respect for timelines
• Attention to detail

Tasks

• Lead strategy for authoring clinical regulatory submissions.
• Ensure compelling scientific content in submissions.
• Prepare key clinical and regulatory documents and submissions.
• Draft responses to regulatory agencies.
• Lead and coordinate cross-functional authoring teams.
• Ensure efficient delivery and high quality of documents.
• Ensure regulatory compliance of clinical documents.
• Liaise with senior project staff.
• Develop storyboards for submissions.
• Plan document development for prescribing information.
• Provide strategic medical writing support to clinical projects.
• Ensure technical quality and compliance of documents.
• Coach and develop less experienced writers.
• Oversee and coordinate medical writers and consultants.

Work Experience

Education

Languages