Manager / Associate Director, Medical Writing – Regulatory Affairs
Location: Morrisville, North Carolina, United States
Job ID: 25105480-OTHLOC-1500-2DAK-2DR
Employment Type: Full-Time
Industry: Clinical Research / Regulatory Affairs / Medical Writing
Role Overview
A leading global biopharmaceutical solutions organization is seeking an experienced Manager / Associate Director, Medical Writing – Regulatory to lead regulatory medical writing operations within clinical development programs. This role combines strategic oversight, people leadership, and hands-on regulatory document expertise to ensure high-quality submissions aligned with global regulatory standards.
The successful candidate will manage medical writing staff, oversee regulatory deliverables, support business development initiatives, and ensure compliance with sponsor objectives and international health authority requirements including FDA and EMA guidelines.
Key Responsibilities
Leadership & People Management
Provide task-specific supervision and leadership to medical writing professionals.
Support hiring, interviewing, onboarding, performance management, compensation recommendations, and professional development planning.
Conduct performance reviews and mentor team members to strengthen regulatory writing capabilities.
Regulatory Medical Writing Oversight
Lead the planning, authoring, review, and assembly of regulatory documents including clinical study reports (CSRs), protocols, investigator brochures (IBs), statistical analysis plans (SAPs), and submission modules.
Perform senior-level review of medical writing deliverables to ensure accuracy, scientific integrity, and regulatory compliance.
Ensure adherence to ICH guidelines, sponsor standards, and global regulatory requirements.
Maintain and develop SOPs, templates, and document development strategies.
Project & Operational Management
Oversee timelines, budgets, and resource planning for full-service clinical development projects and standalone medical writing initiatives.
Track departmental metrics and contribute to performance analytics and forecasting activities.
Support revenue planning, invoicing processes, and financial tracking.
Collaborate cross-functionally with clinical operations, biostatistics, regulatory affairs, and medical affairs teams.
Business Development & Client Engagement
Contribute to proposal development, cost estimation, and bid defense presentations.
Participate in customer meetings and build strong relationships with internal and external stakeholders.
Present quarterly business updates and strategic insights to leadership.
Travel Requirement: Up to 25% as needed.
Experience Required
Advanced degree (PhD, PharmD, MD, MS, or equivalent) in life sciences, pharmacy, medicine, or related scientific discipline preferred.
Minimum 6–8+ years of medical writing experience within clinical research, CRO, or pharmaceutical environments.
Demonstrated experience in regulatory document authoring for global submissions (FDA, EMA, and other international health authorities).
Prior team leadership or management experience in medical writing required for Manager/Associate Director level.
Strong knowledge of ICH guidelines, GCP standards, and regulatory submission frameworks (eCTD).
Experience in budget oversight, forecasting, and project management within clinical development programs.
Core Competencies
Regulatory Medical Writing & Submission Strategy
Clinical Study Report (CSR) Development
ICH, GCP & Global Regulatory Compliance
Cross-Functional Clinical Collaboration
Team Leadership & Performance Management
Budgeting, Forecasting & Resource Planning
Proposal Development & Bid Defense Support
Quality Assurance & Document Governance
Compensation
Annual base salary range: $95,000 – $175,700, depending on experience, qualifications, and competency alignment.
Comprehensive benefits may include Medical, Dental, and Vision coverage, 401(k) with company match, Employee Stock Purchase Plan eligibility, performance-based bonuses, flexible paid time off (PTO), and additional benefits in accordance with federal, state, and local regulations.
Equal Opportunity Statement
The employer is committed to fostering a diverse and inclusive workplace and complies with all applicable employment and disability legislation. Qualified candidates with equivalent education and experience will be considered.
Apply Now
If you are a senior regulatory medical writer or clinical documentation leader seeking to advance into a strategic leadership role, apply today through ThePharmaDaily.com and contribute to accelerating global regulatory submissions and therapy approvals.
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