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

Apply Description The Manager of Medical Writing will oversee and lead the development of high-quality scientific documents, including clinical study reports, regulatory submission documents, publications, and other medical communications. This role requires leadership, strategic oversight, and hands-on writing skills. The ideal candidate will collaborate with cross-functional teams, including clinical, regulatory, and medical affairs teams, to ensure the delivery of accurate, clear, and well-structured documents that meet industry standards and regulatory requirements. Requirements • Leadership & Team Management: • Lead a team of medical writers, providing mentorship, training, and career development opportunities. • Assign tasks, set priorities, and manage timelines to ensure timely and high-quality document delivery. • Foster a collaborative and supportive environment within the team. • Medical Writing Oversight: • Develop and oversee the preparation of clinical study reports (CSRs), clinical study protocols, investigator brochures, regulatory submission documents (e.g., INDs, NDAs), and other scientific/medical documents. • Ensure the accuracy, clarity, and compliance of all documents with internal guidelines, industry standards, and regulatory requirements. • Review and edit documents for consistency, style, and adherence to medical writing best practices. • Cross-Functional Collaboration: • Collaborate with clinical, regulatory, biostatistics, and other functional teams to ensure seamless development of medical writing deliverables. • Coordinate document preparation, review, and approval processes with internal stakeholders and external partners, such as contract research organizations (CROs). • Regulatory & Publication Support: • Support the preparation of regulatory submission documents and assist in the response to regulatory agency inquiries. • Contribute to the preparation of scientific publications, abstracts, posters, and presentations for medical meetings. • Process Improvement & Compliance: • Implement and maintain efficient medical writing processes and tools to improve the quality and efficiency of document preparation. • Ensure that all writing adheres to current guidelines, including ICH E6, ICH E3, GxP, and other relevant regulatory requirements. • Quality Control: • Provide detailed reviews and edits for accuracy, scientific content, grammar, style, and formatting. • Ensure consistent and high-quality medical writing across all deliverables. • Training & Development: • Provide training and development opportunities for junior writers, improving their skills in clinical and regulatory writing. • Stay updated on current industry trends and regulations to ensure the team is aligned with best practices in medical writing. Qualifications • Education: • Advanced degree (PhD, MD, PharmD, MS, or equivalent) in a scientific discipline (e.g., life sciences, pharmacology, biostatistics). • Experience: • Minimum of 5-7 years of medical writing experience, with at least 2-3 years in a leadership or managerial role. • Experience in clinical research, regulatory submissions, or biopharmaceutical industry required. • Proven experience with clinical trial reports, regulatory documents (e.g., IND, NDA), publications, and other medical communications. • Skills: • Strong knowledge of medical writing standards and regulatory requirements. • Excellent writing, editing, and proofreading skills, with the ability to communicate complex scientific concepts clearly and concisely. • Strong project management skills, with the ability to manage multiple projects and meet tight deadlines. • Ability to collaborate effectively with cross-functional teams and external partners. • High attention to detail and a strong commitment to quality. • Certifications: • Medical Writing Certification (e.g., from the American Medical Writers Association, or similar) is a plus but not required. Additional Skills • Familiarity with regulatory guidelines (e.g., ICH, FDA, EMA) and industry standards (e.g., GxP). • Proficiency with medical writing tools (e.g., EndNote, Reference Manager, Microsoft Office Suite, Adobe Acrobat). • Strong interpersonal and communication skills, with the ability to lead and mentor a team. Salary Description $140,000 - $160,000 per year Apply tot his job Apply To this Job