Lead the development, coordination, and delivery of high-quality clinical and regulatory documents, ensuring compliance with global standards.
Implement quality control processes to review and refine clinical and regulatory documents before submission.
Ensure alignment with regulatory requirements and industry best practices to support clinical development programs.
Manage external vendors and consultants, overseeing contract negotiations and quality assurance of their work.
Develop standardized templates and style guides to maintain consistency in medical writing outputs.
Provide training and mentorship to team members to enhance skills and industry knowledge.
Collaborate with cross-functional teams, ensuring integration of medical writing deliverables with broader project timelines and objectives.
Maintain and oversee the budget for the medical writing department, ensuring cost-effective resource allocation.
Stay informed of industry trends and regulatory changes to continuously refine medical writing processes and strategies.
Your responsibilities will also include:
Solving problems by identifying and implementing effective solutions, applying technical expertise, and following best practices.
Contributing to a high-performance culture, ensuring clear communication of expectations, and addressing challenges proactively.
Supporting ongoing improvements in document management and workflow optimization to increase efficiency and reduce turnaround times.
Qualifications
Education and Years of Experience: Advanced degree (preferred) with approximately 3 years of relevant experience OR bachelor’s degree with approximately 8 years of relevant experience.
Interpersonal Skills: Ability to exchange complex information with others in difficult situations. May be required to guide and convince others.
Leadership Skills: Ability to mentor junior members of the team (if applicable).
Business Expertise: Understanding of how own team integrates with others in accomplishing medical writing objectives.
Quality: Strong commitment to quality and attention to detail.
Technical skills: Proficiency in medical writing software and a strong understanding of the technical aspects of the job (quality control and medical writing). Proficiency in the use of standard industry software and tools.
This role is expected to be in office 70% of the time with flexibility to work from home up to 30%.
