Principal Medical Writer

Key responsibilities

• Lead a strategy-driven approach to authoring of the clinical components of regulatory submissions, ensuring a clear, concise, complete, credible and compelling scientific content aligned with the objective of the regulatory document.
• Assume primary responsibility for preparation of key clinical and regulatory documents and documents supporting major regulatory submissions as well as responses to regulatory agencies/ health authorities.
• Provide leadership and project coordination to cross-functional authoring teams, ensuring efficient delivery, high quality, and regulatory compliance of clinical regulatory documents.
• Liaise with senior project staff, prospectively develop a storyboard for the submission, and plan document development to provide optimal support for the proposed prescribing information.
• Assume a Product Medical Writer responsibility, providing strategic medical writing expertise and support to multiple projects in a clinical development program.
• Ensure high technical quality of the documents in compliance with in-house technical requirements.
• Coach and develop less experienced Medical Writers.
• Oversee and coordinate all Medical Writers assisting on documents under your responsibility, including in-house consultants and Medical Writers at CRO.

Qualification and experience

• Life Science Master´s degree or PhD
• A minimum of 8-10 years' experience in regulatory medical writing combined with scientific and regulatory knowledge, plus in-depth knowledge of regulatory medical writing processes.
• Experience in leading complex global regulatory and clinical writing projects, such as complex CSRs, CTDs, Orphan Drug Designations (ODDs), Paediatric Investigation Plans (PIPs), briefing documents and regulatory responses.
• Experience in leading writing activities for major US and/or EMA regulatory submissions, including coordinating the work of other Medical Writers and submission leadership.
• A clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.
• Advanced knowledge of global regulatory environment and processes (key regulatory bodies, key documents, approval processes, safety reporting requirements).

Skills and personal attributes

• Excellent written and spoken English skills
• Highly developed analytical and strategic thinking with an ability to identify key issues
• Ability to communicate difficult and complex ideas clearly and effectively to all stakeholders
• Strong interpersonal, communication and influencing skills, ability to co-ordinate work of others
• Strong team player with a proven ability to drive and manage team performance and to work effectively with people of different cultural, functional and seniority backgrounds
• Result-oriented person with excellent problem-solving skills and flexible attitude
• Ability to manage multiple parallel tasks and prioritize tasks under time pressure
• Highly developed respect for timelines
• Attention to detail

Pay

This role offers a competitive base salary in the range of $160-200K, plus performance-based bonus. Final compensation will be determined based on experience, qualifications, and overall fit.

About Mix Talent

Mix Talent is a specialized recruiting partner focused on building high-performing teams across the life sciences industry. We partner closely with innovative companies to identify talent that drives meaningful impact.