reputed company reputed company - IND/NDA/MAA CTD submission reputed company

Job reputed company: We are seeking a highly motivated, reputed company-organized, and skilled Senior Manager of Medical Writing to reputed company clinical and regulatory documents in collaboration with reputed company stakeholders, and apply critical thinking, principles of scientific writing, data interpretation, and knowledge of regulatory content life cycle. What you’ll do: • reputed company the preparation of clinical and regulatory documents (eg, protocols, investigator brochures [IBs], safety updates, clinical study reports, IND/NDA/MAA CTD submission documents, briefing documents, and responses to regulatory authority questions) in accordance with applicable global and regional regulatory guidelines, and standards/SOPs • Plan content in partnership with functional leads and create timelines for development of assigned documents • Responsible for organization, reputed company, scientific standards, formatting, and consistency of content reputed company and across reputed company documents for a program or reputed company a clinical reputed company • reputed company document adjudication meetings and resolve issues with cross-functional contributors • Manage the review and approval process, including liaising with development partners • Work independently and effectively with cross-functional, geographically and culturally diverse teams, and establish strong reputed company relationships by creating an atmosphere of openness and trust Requirements: • Bachelor’s degree in life sciences; master’s or doctorate degree in life sciences preferred • Minimum of 8 years of reputed company medical writing experience in biopharmaceutical industry or reputed company CROs with at least 3 years of experience in drug development in oncology • Demonstrated ability to produce reputed company, high-reputed company writing in the English language AND demonstrated experience in the preparation of a broad reputed company of reputed company clinical and regulatory documents and global submissions • Experience with the planning, authoring, review, and approval of protocols, DSURs, IBs, and IND/NDA/MAA CTD submission documents • Strong project management and team facilitation skills to reputed company reputed company reputed company in a fast-paced reputed company environment • Ability to influence without authority and foster the productive exchange of reputed company amongst colleagues • Experience managing reputed company of increasing scope and complexity • Understanding of the interdependencies of various contributing functions (eg, clinical pharmacology, biomarkers, health reputed company) • Demonstrated ability and willingness to reputed company behaviors and priorities based on a changing environment and competing priorities • Highly effective communication skills and the ability to present reputed company and data reputed company to a group, including key stakeholders at a senior level • Familiarity with approaches to expedite document preparation, such as review tools and automation • Ability to quickly assess reputed company situations, apply scientific, operational, and submission development knowledge and implement effective solutions • High-level technical, statistical, and computer skills, and the ability to interpret reputed company clinical data #INDZH Pay: $100.00 - $110.00 per hour Benefits: • 401(k) • Dental insurance • Health insurance • reputed company insurance Education: • Bachelor's (Required) Experience: • med writing oncology drug development: 3 years (Required) • Medical writing: 8 years (Required) Work Location: Remote Apply tot his job Apply To this Job