Associate Director, Medical Writing
Location: United States
Time Type: Full-time
Posted: 3 Days Ago
Job Requisition ID: JR 6657
About ProPharma Group:
For over 20 years, ProPharma has been improving the health and wellness of patients by providing valuable expertise to the biotech, medical device, and pharmaceutical industries. As the world’s largest Research Consulting Organization (RCO), ProPharma supports clients through an advise-build-operate model across the full product lifecycle. The company offers customizable consulting solutions, focusing on regulatory sciences, clinical research, quality & compliance, pharmacovigilance, medical information, and R&D technology to accelerate drug and device programs.
Position Overview:
The Associate Director, Medical Writing will manage and lead the medical writing team, ensuring high-quality deliverables for clinical and regulatory documents. The role will involve overseeing the production of study documents for clients and ensuring that medical writing resources are efficiently allocated. This position requires expertise in clinical research, regulatory requirements, and document management.
Essential Functions:
Team Management & Coordination:
Define and manage medical writing resource needs in collaboration with medical writing leadership.
Ensure appropriate communication with internal functional areas, business development teams, and recruiting for medical writing resource requirements.
Provide leadership for cross-functional coordination and resource management for medical writing deliverables.
Document Management:
Author and manage key documents for clinical trials, including protocols, study reports, patient narratives, IBs, ICFs, and regulatory submission-level documents (e.g., IND, NDA, BLA).
Oversee and review documents authored by less experienced medical writers, ensuring compliance with regulatory guidelines (e.g., ICH, FDA).
Project Management:
Manage project timelines, budgets, and resource allocation.
Oversee the production of deliverables, ensuring timely and on-budget completion.
Support business development activities, including proposal development, client meetings, and budget reviews.
Quality Control & Mentorship:
Perform peer and manager reviews of medical writing deliverables.
Mentor and supervise junior writers, helping them grow professionally and improve their writing skills.
Business Development Support:
Participate in bid defenses and develop capabilities presentations.
Assist in the development of business proposals and contracts.
Necessary Skills & Abilities:
Expert Knowledge:
Advanced understanding of clinical research principles and regulatory submission requirements (e.g., ICH, FDA).
Expertise in writing clinical and regulatory documents for drugs, biologics, medical devices, and diagnostics.
Leadership & Project Management:
Strong leadership skills with experience in managing teams and resources.
Excellent project management skills, with a focus on managing timelines, budgets, and client relationships.
Experience in business development and client management, with the ability to foster relationships and drive results.
Technical Proficiency:
Expert-level proficiency in MS Word, including skills in formatting documents, creating tables, graphs, and figures.
Familiarity with budgeting, forecasting, and resource management.
Communication:
Exceptional verbal and written communication skills.
Proficient in American Medical Association (AMA) style and medical writing guidelines.
Educational Requirements:
Bachelor’s degree or higher, preferably in a medical or scientific discipline.
Experience Requirements:
Minimum of 6 years of experience in medical writing, with a focus on clinical and regulatory documents.
At least 3 years of experience in project and resource management.
Why ProPharma?
ProPharma is committed to diversity, equity, and inclusion, offering a collaborative and innovative work environment. The company fosters a culture where employees can be their authentic selves and are empowered to succeed.
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