Job Description

Title: Senior Manger, Medical Writer Location: Thousand Oaks, CA or San Francisco, CA Company Description: Latigo Biotherapeutics, Inc. is a private, early-stage biotechnology company focused on discovering and developing the next generation of non-opioid medicines for pain and pain-related syndromes. Our mission is the development of novel therapies that transform the lives of patients. The company is headquartered in Thousand Oaks, CA and has a highly successful management team as well as an experienced Board of Directors. At Latigo, we value science, patient-focus, and innovation. Position Description: The Medical Writer will collaborate with internal teams to lead, write, and manage completion of clinical regulatory documents. This role is for an individual contributor, reporting to the Vice President, Clinical Regulatory Affairs. This role includes responsibilities throughout the lifecycle of a document including working cross-functionally to interpret source information (including leading data interpretation meetings), leading key messaging meetings, writing content following US and international regulations, conducting quality control (QC) reviews, resolving Quality Assurance (QA) audit findings, and working with Regulatory Operations for publishing and submission. This position can be on-site either in Thousand Oaks or the SF Bay Area Primary Responsibilities:Collaborate with internal teams to lead, write, and manage clinical regulatory documents (e.g., clinical study reports, Investigator Brochures, clinical study protocols, briefing documents, marketing application summary documents, etc.) through to finalization.Coordinate the review cycles for documents; schedule and lead data interpretation meetings, comment resolution meetings, and other document-related meetings.Responsible for planning and meeting timelines for deliverables.Understand, assimilate, and interpret sources of information with appropriate guidance.Ensure compliance with appropriate conventions, proper grammar usage, and correct format requirements, as needed (e.g., formatting, hyperlinking).Perform quality control (QC) reviews as necessary.Interact with Quality Assurance (QA) to resolve audit findings for specific documents.Serve as Medical Writing department representative on project/core teams.Lead key messaging/storyboarding cross-functional meetings, ensuring the messages are clear and consistent within and across documents.Maintain expert knowledge of US and international regulations, requirements, and guidance associated with preparation of regulatory documentation.Effectively coordinate with Regulatory Operations to ensure on-time preparation and publication of regulatory submission documents.Support Global Regulatory Lead with preparing information/responses requested by regulatory agencies.Other duties as assigned. Qualifications and Requirements:Bachelor's Degree required, advanced degree a plus.A minimum of 5 years of direct experience as a medical writer preparing regulated documents in the biopharma industry. Experience in pain related therapeutics is a plus.Experience writing clinical study reports (all sections including safety narratives), Investigator Brochures, clinical study protocols, marketing application summary documents, Investigational New Drug applications, clinical sections of New Drug Applications, and other regulatory documents (e.g., Briefing Documents) for submission. In-depth experience in writing Safety sections of regulatory documents preferred.Solid working knowledge of relevant FDA, EMA, and ICH guidelines.Deep understanding of the drug development process.Strong ability to assimilate and analytically interpret scientific data. Experience preparing data tables and basic figures preferred.Excellent attention to detail and time-management skills. Ability to balance multiple projects simultaneously.Ability to develop, roll-out and follow style guides, lexicons, and eCTD templates etc.Excellent written, oral (including presentations) and project management skills.Energetic, self-motivated, and a hands-on professional with a strong work ethic.Ability to work collaboratively in a dynamic environment.Desire and ability to be a true team player working toward common goals.An ability to be productive and successful in an intense work environment.Salary ranges from $165,000 - $195,000 Latigo Bio

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