Senior Principal Medical Writer

Work Your Magic with us! Start your next chapter and join EMD Serono.

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your Role:

As the Senior Principal Medical Writer, you will lead the end-to-end development of complex regulatory submission documents – ensuring high communication quality, scientific rigor, regulatory compliance, and timely delivery across international markets. Acting as the primary medical writing lead within cross-functional teams, you will define document strategy, shape submission timelines, and align stakeholders across clinical, regulatory affairs, pharmacovigilance, and statistics. Beyond your individual contributions, you will mentor and develop fellow writers, champion best practices, and drive consistency and quality across deliverables. This is a role for a seasoned professional who combines deep medical writing expertise with the ability to influence decisions, lead without authority, and deliver with precision on programs that directly advance patient health.

Location: Hybrid – 3x/week onsite in Billerica, MA required.

Key Responsibilities:

• Lead medical writing efforts for global, priority programs across the full regulatory documentation suite (protocols, clinical study reports, Investigator’s Brochures, briefing books, clinical summaries, pediatric plans, authority responses, etc.).

• Act as Lead Writer/oversight for clinical sections of regulatory dossiers (eCTD) for global market approvals.