Director - Global Medical Writing

Description: • This is an exciting leadership opportunity for a person with passion and talent. • The company believes that medical writing is a science that continuously evolves with new regulations and technologies. • The role provides the ability to influence company leaders and work on exciting fast-paced drug development programs. • This is your chance to join a dynamic Medical Writing team and be part of an emerging success story driven by the company’s unwavering commitment to patients and employees. • The Medical Writing team is looking for an experienced, self-motivated individual knowledgeable of the current MW landscape to serve as Director, Medical Writing. • The individual will be responsible for leading document strategy and development of complex clinical documents across programs/submissions. Requirements: • PhD or equivalent plus 8+ years of experience, or Masters/Bachelors plus 12+ years of experience • Extensive experience authoring regulatory and clinical documents for global submissions, including strong submission experience across ICH regions (NDA, NDS, MAA, IND) with active contribution in planning and preparation of summary documents • Excellent verbal and written communication skills and attention to detail related to consistency, grammar, syntax, and accuracy • Experience producing high quality clinical documents • Knowledge of clinical trial disclosure • Strong organizational/prioritization skills for the management of multiple concurrent documents • Demonstrated proficiency with eCTD Starting Point templates, Smart Sheet, databases, presentation software (MS Office skills such as Teams, Outlook, Word, Excel, PowerPoint, and SharePoint), Veeva Vault, • Oncology, immunology and/or neurology experience is highly preferred Benefits: • Competitive salary and annual bonus. • Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more. • Generous parental leave and family planning benefits. • Outstanding culture and opportunities for personal and professional growth. Apply tot his job Apply To this Job