Chief Medical Writer

Overview We are seeking an experienced and dynamic Chief Medical Writer (Team Head) to lead and oversee the medical writing team. This role involves managing the development of high‑quality scientific and regulatory documents, ensuring compliance with industry standards, and fostering a collaborative and productive team environment. The ideal candidate will have extensive experience in medical writing, strong leadership skills, and a thorough understanding of regulatory requirements. Key Responsibilities Leadership and Team Management Provide strategic direction to the medical writing team. Recruit, train, mentor, and manage a team of medical writers. Delegate tasks effectively while ensuring timely delivery of high‑quality outputs. Foster a positive and collaborative team culture. Document Development Oversee the creation of clinical trial protocols, investigator brochures, clinical study reports, regulatory submissions, and other scientific documents. Ensure all documents adhere to regulatory guidelines, templates, and internal quality standards. Review and provide critical feedback on documents drafted by team members. Cross‑Functional Collaboration Collaborate with cross‑functional teams, including clinical, regulatory, medical affairs, and biostatistics teams, to gather relevant information for document preparation. Act as a key liaison between internal and external stakeholders on medical writing deliverables. Quality Assurance and Compliance Maintain compliance with International Council for Harmonisation (ICH) guidelines, Good Clinical Practice (GCP), and other regulatory and scientific standards. Implement and monitor quality control processes to ensure consistency and accuracy in all deliverables. Strategic Planning Contribute to the development of medical writing strategies and timelines for projects. Identify and resolve challenges in medical writing projects, providing innovative solutions to meet project goals. Training and Development Organize and conduct training sessions to enhance the skills of the medical writing team. Stay updated on industry trends, regulatory changes, and medical advancements to maintain excellence in medical writing practices. Requirements Education and Experience Advanced degree (Master's or Ph.D.) in life sciences, medicine, pharmacy, or a related field. Minimum of 8-10 years of experience in medical writing, with at least 3-5 years in a leadership role. Proven track record of delivering high‑quality regulatory and scientific documents. Skills and Competencies Technical Expertise Strong understanding of clinical research, drug development processes, and regulatory requirements. Proficiency in medical and scientific terminology. Ability to lead and motivate a team of professionals. Excellent project management and organizational skills. Communication Skills Exceptional written and verbal communication skills. Ability to present complex scientific information clearly and concisely. Analytical Skills Strong attention to detail and critical thinking abilities. Capacity to analyze, synthesize, and interpret scientific data. Software Proficiency Proficiency in Microsoft Office Suite and familiarity with document management systems. Experience with statistical software or tools is a plus. Preferred Qualifications Experience in preparing documents for FDA, EMA, or other global regulatory agencies. Certification in medical writing (e.g., AMWA, EMWA, or similar) is an advantage. Experience managing medical writing teams in a CRO, pharmaceutical, or biotech environment. Application Questions How many years' experience do you have in a publishing role? Which of the following statements best describes your right to work in Hong Kong? Do you have technical writing experience? What's your expected monthly basic salary? How would you rate your English language skills? How many years' experience do you have as a Medical Writer? Which of the following Microsoft Office products are you experienced with? #J-18808-Ljbffr