Regulatory Submissions Writer – Neurology Job at Albion Rye Associates in Boston

Are you a skilled medical writer with a passion for regulatory submissions? This is an opportunity to play a pivotal role in advancing treatments for central nervous system (CNS) disorders, supporting high-impact filings that can change patient lives.

What you’ll do :

Lead the authoring of Module 2 clinical summaries, benefit–risk narratives, and other key regulatory documents.

Collaborate with cross-functional teams (clinical, biostatistics, regulatory affairs) to ensure accuracy, clarity, and compliance.

Interpret and present complex clinical data in a concise, compelling way.

Contribute to submission strategy, aligning content with global regulatory expectations.

Ensure deliverables meet strict quality standards and timelines.

What we’re looking for :

Significant experience in regulatory writing, ideally with NDA / BLA or global submissions.

Strong knowledge of ICH guidelines and FDA / EMA requirements.

Background in neurology or CNS disorders highly desirable.

Advanced degree in life sciences (PhD, PharmD, or MSc preferred).

Proven ability to manage multiple priorities in a fast-paced environment.

Why join :

Contribute to ground breaking neurology submissions at the cutting edge of science.

Be part of a collaborative, science-driven Boston team.

Competitive compensation, benefits, and career progression opportunities.

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