Head of Medical Writing, Rare Disease 1110094 Job Scope Purpose Our long-standing, rare-disease focused client is on the heels of their first approval and seeking a Head of Medical Writing with project management experience to join their impressive team. This individual will fall in a Director or AD level in experience, and manage clinical and regulatory documents for multiple programs. This individual will oversee a team of external Medical Writers to ensure the effective management and timely execution of scientifically accurate, informative, and persuasive documents for regulatory filings, with aligned messaging across documents. Primary Job Responsibilities Help develop messages and ensure consistency across clinical and regulatory documents. Serve as point person for communication between all writing vendors and internal teams. Proactively contribute to development and implementation of Medical Writing best practices and improvements leading to efficient systems, processes and tools for authoringreviewingediting documents and training of medical writing vendors Lead Medical Writing vendors to facilitate efficient development, review, and finalization of clinical and regulatory documents. Includes developing timelines, lining up resources, scheduling review meetings, and follow up activities with reviewers to ensure timely completion of key documents for complex global programs, such as Protocols, Clinical Study Reports, Investigator's Brochures, Briefing Books, Clinical Summaries, Pediatric Plans, responses to health authorities, etc. Where needed, act as lead Medical Writer with oversight for clinical sections of eCTDs for global market approval you will be required to create medically and scientifically accurate, informative, and persuasivestrategic content. Lead document-related meetings, provide updates to teams during cross-functional meetings, review statistical analysis plans. Provide document strategy and resource needs for programs Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents. Participate in initiatives aimed at improving internal standards and systems Responsibilities may include initiating projects using external vendors from bid stage through project completion. Primary Job Requirements Minimum BS in a scientific or writing discipline MS or PhD preferred 5- 10 years of relevant medical writing experience with strong project management skills Direct experience in the pharmaceuticalbiotech industry with thorough understanding of drug development and strategy for regulatory submissions Superior writing and editorial skills, strong data analysis skills, ability to understand complex scientific and clinical information and create consistent strategic messaging for diverse healthcare professional audiences Ability to coordinate work of multiple writers and vendor resources across multidisciplinary teams including clinical operations, data management, biostatistics, medical affairs, and pharmacovigilance Teamwork and collaboration are a must Strong communication and organizational skills Strong Clinical Trial development knowledge Shows innovation and ability to implement change Expert in WordAdobeElectronic document management systems About Stratacuity Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENTTrademark Stratacuity is an Equal Employment OpportunityAffirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. 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