Senior Principal Medical Writer

EMD Serono, Inc.; Billerica (MA); Hybrid; USD 126,900 - 215,400; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Job summary

EMD Serono, Inc. is seeking a Senior Principal Medical Writer to lead end-to-end development of regulatory submission documents, ensuring scientific rigor, regulatory compliance, and timely delivery across global markets. You will serve as the primary writing lead within cross-functional teams, shaping strategy and timelines.

Hybrid role based in Billerica, MA with 3 days on site. You will mentor writers, drive best practices, coordinate with clinical, regulatory, pharmacovigilance, and

Qualifications

• Bachelor's degree in a scientific or writing discipline; Master's or PhD preferred.
• 5-8 years of 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.

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.
• Represent Medical Writing in cross-functional teams; participate in governance and project meetings.
• Define and implement document strategy, resource needs, and timelines; manage deliverables from vendors and external writers as needed.
• Mentor and develop writers; drive adoption of MW best practices and standards.
• Manage documentation strategy, quality, and consistency across indications; ensure alignment with regulatory expectations.
• Coordinate with cross-functional teams (clinical, pharmacovigilance, regulatory affairs, statistics) to ensure timely and compliant delivery.

Skills

Regulatory writing

Cross-functional leadership

Vendor coordination

English communication

Education

Bachelor's degree in science or writing

Master's or PhD preferred

Tools

SharePoint

MW templates

Document management systems

Job description

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.
• Represent Medical Writing in cross-functional teams; participate in governance and project meetings.
• Define and implement document strategy, resource needs, and timelines; manage deliverables from vendors and external writers as needed.
• Mentor and develop writers; drive adoption of MW best practices and standards.
• Manage documentation strategy, quality, and consistency across indications; ensure alignment with regulatory expectations.
• Coordinate with cross-functional teams (clinical, pharmacovigilance, regulatory affairs, statistics) to ensure timely and compliant delivery.

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

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

Benefits

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