Principal Medical Writer

Millipore Corporation; Billerica (MA); Hybrid; USD 127,000 - 215,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Job summary

EMD Serono is seeking a Principal Medical Writer to lead end-to-end development of regulatory clinical study documents, ensuring scientific rigor and regulatory compliance globally and regionally. You will mentor writers, oversee CTD-style documents, and coordinate with cross-functional teams to meet timelines.

The role is hybrid with onsite requirements in Billerica, MA, and offers opportunities to influence best practices in medical writing across multiple markets.

Qualifications

• Bachelor's degree required in a scientific or writing discipline; advanced degree preferred.
• 5–8 years of medical writing experience with regulatory documentation background.
• Experience leading and coordinating local/global teams in a matrix organization; vendor management is a plus.

Responsibilities

• Lead global and regional clinical study documents (protocols, CSRs, authority responses).
• Represent Medical Writing in study teams; participate in governance and meetings.
• Oversee document reviews and coordinate with cross-functional teams to ensure regulatory compliance.

Skills

Medical writing

Regulatory documents

Project management

Communication

Education

Bachelor's degree in science or writing

Tools

MS Office

SharePoint

Electronic document mgmt systems

Job description

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 Principal Medical Writer, you will lead the end-to-end development of complex regulatory clinical study documents - ensuring high communication quality, scientific rigor, regulatory compliance, and timely delivery both globally and at regional/local levels. Acting as the study medical writer within cross-functional teams, you will independently prepare or oversee the preparation of clinical and regulatory documents such as Protocols and Clinical Study Reports for noninterventional and interventional studies up to Phase 4. You will be responsible for strict adherence to business objectives, company standards, as well as the organization of content, clarity of text and tables, overall consistency, and appropriate use of English language/grammar. You will represent the department as a subject-matter expert on clinical study teams, leading document-related meetings and reviewing study-related documents. Beyond your individual contributions, you will mentor and develop fellow writers and contribute to the development and implementation of best practices and standards. This is a role for a seasoned professional who combines medical writing expertise with the ability to lead without authority and deliver with precision on studies that directly advance patient health.

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

Key Responsibilities:

• Lead medical writing efforts for global, as well as regional/local clinical study documents (protocols, clinical study reports, authority responses, etc.).
• Represent Medical Writing as subject matter expert in study teams; participate in governance and study team meetings.
• Lead document-related meetings reviews study-related documents such as statistical analysis plans.
• Define and implement document strategy, and timelines.
• Oversee and coordinate other (external) writers assisting on documents under your responsibility, with focus on adherence to business objectives and company standards and SOPs, and meet the requirements of regulatory authorities and the company.
• Proactively contribute to the development and implementation of MW best practices and process improvements.
• Coordinate with cross-functional teams (clinical, pharmacovigilance, regulatory affairs, statistics) to ensure timely and compliant delivery.

Who You Are:

Minimum Qualifications

• Bachelor's degree in a scientific or writing discipline; Master's or PhD preferred.
• 5-8 years of relevant medical writing experience in pharma/biotech, with strong regulatory documentation background.
• Lead and oversee medical writing activities (including vendor resources) within a clinical trial, as well as leading and coordinating local/global teams in a matrix organization
• Solid CTD/CTD-like knowledge; experience across multiple markets is a plus.
• Solid knowledge of regulatory requirements, industry standards, and best practices related to medical writing; experience across multiple markets is a plus.
• Excellent written and verbal English.
• Technical expertise in Microsoft Office suite, electronic document management tools.
• Ability to travel as needed.

Preferred Qualifications

• Experience with country-specific submissions.
• Proficiency with document management systems, SharePoint, and standard MW templates.
• Experience with non-interventional study designs and device studies in development and post-approval settings
• Familiarity with industry best practices and evolving regulatory guidelines and experience in everyday AI applications
• Strong project management, communication, collaboration, and problem-solving skills
• High attention to quality, accuracy, and compliance

Pay Range for this position: $126,900 - 215,400

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses.

• Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!