Chief Medical Writer

Job Summary:

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:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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:

1. Technical Expertise:

- Strong understanding of clinical research, drug development processes, and regulatory requirements.

- Proficiency in medical and scientific terminology.

2. Leadership Skills:

- Ability to lead and motivate a team of professionals.

- Excellent project management and organizational skills.

3. Communication Skills:

- Exceptional written and verbal communication skills.

- Ability to present complex scientific information clearly and concisely.

4. Analytical Skills:

- Strong attention to detail and critical thinking abilities.

- Capacity to analyze, synthesize, and interpret scientific data.

5. 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.