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Senior Principal Medical Writer

Merck KGaA →Billerica, MA· posted Jul 17, 2026
RegulatoryLead

We are expanding our team: As Senior Principal Medical Writer, you will lead the development of complex regulatory submission documents, ensuring scientific rigour and regulatory compliance. This role suits a seasoned professional with significant medical writing experience in pharma/biotech, adept at leading cross-functional teams and mentoring writers.

requirements

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. • Proven ability to lead multiple writers and coordinate vendor resources for regulatory submissions (IND/IMPD, bridging documents, briefing books, etc.). • Solid CTD/CTD-like knowledge; experience across multiple markets is a plus. • Excellent written and verbal English; strong presentation and collaboration skills. • Ability to travel as needed. Preferred Qualifications: • Experience with country-specific submissions and post-approval documents • Proficiency with document management systems, SharePoint, and standard MW templates • Familiarity with industry best practices and evolving regulatory guidelines • Strategic document planning and cross-functional leadership • Deep knowledge of regulatory submission requirements and lifecycle management • Vendor management and remote leadership • Strong communication, negotiation, and stakeholder management • 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. For more information click here. 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! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

skills Bork detected

Cross-functional Leadership
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