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Associate Director, Clinical Medical Writing - Job Opportunity at BioMarin

London, United Kingdom
Full-time
Senior
Posted: April 6, 2025
On-site
USD 150,000 - 180,000 per year based on London market rates for senior medical writing positions in biotech

Benefits

Comprehensive healthcare program typical of global biotech firms
Career development and scientific publication opportunities
Work on innovative rare disease treatments
Global exposure and cross-functional collaboration opportunities

Key Responsibilities

Strategic oversight and management of Medical Writing staff
Cross-functional leadership in clinical documentation and regulatory submissions
Vendor management and resource allocation
Development of clinical study documentation and regulatory filings
Process standardization and quality control implementation

Requirements

Education

Masters (MS) or higher degree preferred; scientific focus desirable

Experience

Minimum 10 years as medical writer in pharmaceutical industry, plus 3 years management experience

Required Skills

Advanced understanding of drug development process Clinical study documentation expertise Regulatory submission experience Project management capabilities Advanced medical writing skills Proficiency in Microsoft Office suite and document management systems Strong communication and leadership abilities

Certifications

European/American Medical Writers Association certificate (preferred) Editor in Life Sciences certificate (preferred)
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Sauge AI Market Intelligence

Industry Trends

Increasing focus on rare disease therapeutics requiring specialized medical writing expertise Growing complexity in regulatory documentation requirements across global markets Rising demand for medical writers with both scientific expertise and management capabilities Shift towards digital documentation systems and AI-assisted writing tools

Role Significance

Typically managing 5-8 direct reports in a matrix organization structure
Senior leadership position with significant influence on regulatory strategy and documentation quality

Key Projects

Regulatory submissions for novel rare disease therapeutics Clinical trial documentation for first-in-class treatments Process standardization and departmental optimization initiatives

Success Factors

Deep understanding of rare disease therapeutic development Strong regulatory strategy expertise Ability to build and lead high-performing teams Excellence in stakeholder management across global operations

Market Demand

High demand with limited talent pool due to specialized expertise requirements in rare disease space

Important Skills

Critical Skills

Regulatory documentation expertise spanning multiple global regions Strategic leadership in medical writing department development Advanced understanding of rare disease therapeutic development

Beneficial Skills

Experience with digital documentation systems Knowledge of emerging regulatory requirements Change management capabilities

Unique Aspects

Opportunity to work on first-in-class rare disease therapeutics
Direct impact on bringing novel treatments to underserved patient populations
Complex regulatory landscape requiring specialized expertise

Career Growth

2-4 years typical progression timeline to next level based on business impact and regulatory success

Potential Next Roles

Director of Medical Writing Head of Regulatory Affairs Senior Director of Clinical Operations

Company Overview

BioMarin

Leading global biotechnology company focused on rare disease therapeutics with strong R&D pipeline

Well-established player in rare disease space with multiple approved products and strong financial position
Strategic UK/European presence supporting global clinical development programs
Innovation-driven environment with strong focus on scientific excellence and patient impact
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