KEY RESPONSIBILITIES:
Leadership and Strategy:
Direct and support the medical writing team by offering mentorship, constructive feedback, and performance evaluations to ensure timely and successful project completion.
Partner with senior leadership, clinical development, regulatory affairs, and other departments to align medical writing initiatives with broader clinical development strategies.
Establish and refine writing processes, templates, and best practices to promote consistency, quality, and regulatory compliance.
Ensure all medical writing activities adhere to relevant regulatory guidelines, industry standards, and internal policies.
Document Development and Review:
Supervise the creation of critical regulatory and clinical documents, such as clinical trial protocols, investigator brochures, briefing documents, clinical study reports (CSRs), and clinical sections of IND/CTA/NDAs/BLAs.
Guarantee that medical writing deliverables are completed on schedule and maintain the highest standards of scientific integrity, regulatory accuracy, and quality.
Oversee and review work produced by team members, including manuscripts, abstracts, posters, and other scientific communications.
Regulatory Submissions and Support:
Lead the preparation of documents required for regulatory submissions (e.g., IND, NDA, BLA), ensuring alignment with relevant regulations and guidelines (FDA, EMA, ICH).
Collaborate closely with regulatory affairs teams to refine documents for submission, ensuring clinical data and trial outcomes are presented clearly and accurately.
Contribute to drafting and reviewing responses to inquiries and comments from regulatory agencies.
Collaboration and Communication:
Facilitate effective communication with internal and external stakeholders, managing expectations, addressing concerns, and aligning on document timelines and content.
Provide training and guidance to internal teams on medical writing best practices and collaborative authoring techniques for regulatory documents.
Team Development and Oversight:
Mentor and support medical writers, fostering their growth and professional development.
Define performance metrics and key indicators to monitor and ensure the successful completion of medical writing deliverables.
Cultivate a culture of continuous learning and improvement within the medical writing team.
QUALIFICATIONS:
Education:
Advanced degree (Ph.D., M.D., or Pharm.D.) in a scientific or medical field preferred. Candidates with a Bachelor's or Master's degree in Life Sciences, Pharmacy, or related disciplines with relevant experience will also be considered.
Experience:
Minimum of 10 years of medical writing experience in the pharmaceutical or biotechnology sectors, including at least 5 years in a leadership capacity.
Comprehensive experience drafting regulatory documents for clinical trials across all phases (Phase 1 to Phase 3).
Proven expertise in preparing regulatory submissions (IND, NDA, BLA) with a strong understanding of relevant guidelines (FDA, EMA, ICH).
Solid history of team management, mentoring writers, and collaborating effectively with cross-functional groups.
Skills:
Outstanding written and verbal communication skills, capable of conveying complex scientific concepts clearly and concisely.
Meticulous attention to detail and a strong commitment to producing high-quality documents.
Proficient in handling multiple priorities, meeting deadlines, and operating in a fast-paced environment.
Skilled in using medical writing software and document management systems.
Effective leadership abilities with a talent for motivating and guiding medical writing teams.
