Job Description

We are seeking a skilled Regulatory Medical Writer to deliver high-quality documentation for both internal and external clients. This role involves providing technical consultation and strategic advice on regulations and industry best practices, demonstrating expertise in specific therapeutic areas. The candidate will effectively manage medical writing projects, ensuring timely delivery of quality products while fostering collaboration with internal and external stakeholders to achieve operational excellence. Essential Duties and Responsibilities: Independently research, write, and edit peri- and post-approval documents, including clinical study reports, study protocols, informed consent forms, and other regulatory documents. Support complex documents such as Investigator Brochures (IBs) and sections of INDs, NDAs, and CTDs as needed. Manage all aspects of project planning, organization, and execution autonomously, including developing project timelines, standards, budgets, forecasts, and contract modifications. Collaborate with other functional units (e.g., project management, clinical, QA, data management, biostatistics) to ensure project success. Analyze diverse problems where evaluation of data requires identifying various factors. Interact with internal and external personnel on significant matters, coordinating between functional areas and networking with senior personnel in your area of expertise. Operate with minimal supervision, demonstrating good judgment in selecting methods and techniques for effective solutions. Serve as the primary contact for projects, participating in project launch meetings, review meetings, client audits, bid defenses, and capabilities presentations. Build and maintain client relationships while independently initiating and leading client interactions. Assist with business development activities, including the development of budgets and proposals. Education, Professional Skills & Experience: Bachelor s degree in a scientific discipline or equivalent; an advanced degree is preferred. A minimum of 2-5 years of relevant writing experience in the pharmaceutical or CRO industry, or a combination of education, training, and experience. Preferred qualifications include certifications in medical writing (AMWA, EMWA, BELS, RAC) and significant knowledge of document development guidelines. In-depth knowledge in specialty areas such as therapeutic writing, regulatory submissions, or healthcare communications. Proficient in document management systems and applications like Excel and Outlook. Personal Skills & Competencies: Excellent written communication skills in English, with the ability to produce organized, error-free documents tailored to various audiences. Strong aptitude for working with and manipulating numerical data to provide insights and evidence. Capable of analyzing complex issues, identifying information gaps, and generating effective solutions. Proven ability to create and manage project plans that support overall objectives, guiding team members and reporting progress systematically. Demonstrate sound professional judgment in addressing inquiries, issues, and escalations. Facilitate conflict resolution among team members and clients through effective communication and understanding.

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