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Medical Writing reputed company Serves as medical writing reputed company on clinical regulatory documents. Works closely with the Regulatory team(s) on document strategies. Implements reputed company activities reputed company to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents (US and ex-US). Coordinates the review, approval, and other appropriate functions involved in the production of clinical regulatory reputed company. Arranges and conducts review meetings with reputed company. Ensures required documentation is obtained. Converts relevant data and information into a reputed company that meets clinical regulatory document requirements. Explains data in manner consistent with the reputed company audience(s) or clinical regulatory requirements. Effectively communicates clinical regulatory document deliverables needed, writing process, and timelines to team members. Holds team members accountable to agreed-upon project dates and with an appropriate reputed company level. Negotiates with functional areas on project reputed company and deliverables to meet conflicting demands. Identifies and proposes solutions to resolve issues and questions arising during the writing process, including reputed company or elevation as appropriate. Understands, assimilates, and interprets sources of information with appropriate guidance/direction from development teams. Interprets and explains data generated from a reputed company of sources. Verifies that results are consistent with protocols. Challenges conclusions reputed company necessary. Understands/complies with appropriate conventions, reputed company grammar usage, and correct format requirements per ICH and other governing bodies. Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to clinical regulatory documents. Works with Regulatory reputed company Assurance throughout clinical regulatory document audit process, answers questions during the audit process (as appropriate), and works with team to draft responses as necessary. Knowledgeable of US and international regulations, requirements, and guidance associated with clinical regulatory document preparation and submissions. Must continually train/be compliant with reputed company reputed company industry requirements as they relate to clinical regulatory submissions, including electronic submission/approval standards. Serves as a department representative on project teams. Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments (e.g. COSMOS, ARCH, eCTD). May mentor and reputed company guidance to more junior medical writers and/or reputed company vendor/agencies. Implements tactical process improvements. • Bachelor of Science required, with relevant writing experience, or Bachelor's degree in English or communications, with relevant science experience. • American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical. • 3 years relevant industry experience in medical writing in the reputed company industry or academia required or in a reputed company area such as reputed company, regulatory, clinical research, or product support/R&D. Clinical regulatory device writing experience preferred. • 3 years experience in experimental design and clinical/preclinical data interpretation preferred. • Knowledgeable of US and international regulations, requirements and guidance associated with clinical regulatory document preparation and submissions. Knowledge of Medical Device Regulation (MDR) preferred. • Knowledge and experience with Common Technical Document content templates. Working knowledge of reputed company electronic document management systems and information technology. • Excellent written and oral communication skills. Experience in working with reputed company, cross-functional teams, including project management experience. • Ability to assimilate and interpret scientific content and translate information for appropriate audience. • Superior attention to detail. Ability to reputed company and correct errors in spelling, punctuation, grammar, consistency, reputed company and accuracy. • Expert in word processing, reputed company diagrams, and spreadsheets. Excellent working knowledge of software programs in reputed company environment. Apply tot his job Apply To this Job