[Hiring] Director of Medical Writing @Global Regulatory Writing Consulting Inc

Role Description

The Director of Medical Writing is a senior leadership role responsible for overseeing the strategic direction, management, and execution of medical writing activities across clinical, regulatory, and publication-related projects. This position will play a critical role in ensuring that all medical writing deliverables meet the highest standards of quality, scientific rigor, and regulatory compliance.

• Lead a team of medical writers
• Collaborate with key stakeholders
• Drive process improvements
• Contribute to the success of the company’s clinical and regulatory goals

Qualifications

• Advanced degree (PhD, MD, PharmD, MS, or equivalent) in a scientific discipline (e.g., life sciences, pharmacology, medical sciences) required
• Minimum of 8-10 years of medical writing experience in the pharmaceutical, biotechnology, or healthcare industry, with at least 5 years in a leadership or senior management role
• Proven experience in overseeing complex regulatory submissions, clinical study documentation, and scientific publications
• In-depth knowledge of global regulatory requirements, ICH guidelines, GxP, and medical writing standards
• Strong leadership and team management skills
• Excellent written and verbal communication skills
• Strong project management skills
• Advanced knowledge of medical writing tools (e.g., Microsoft Word, EndNote, Reference Manager, Adobe Acrobat) and regulatory submission platforms

Requirements

• Develop and execute the strategic vision for the Medical Writing department
• Lead, mentor, and manage a team of medical writers and medical writing managers
• Oversee the preparation of all types of scientific and regulatory documents
• Ensure that documents are scientifically accurate, clear, and compliant with regulatory guidelines
• Collaborate with clinical development, regulatory affairs, biostatistics, pharmacovigilance, and other internal stakeholders
• Ensure all medical writing deliverables comply with regulatory guidelines, ethical standards, and industry best practices
• Define and implement best practices and standard operating procedures (SOPs) for medical writing
• Oversee the preparation of manuscripts, abstracts, posters, and presentations for peer-reviewed publications
• Provide leadership in the recruitment, training, and development of medical writing staff
• Manage the department’s budget, including allocating resources appropriately for ongoing projects

Company Description