Principal Medical Writer - Regulatory and Medical Writing

divh2Principal Medical Writer - Regulatory And Medical Writing/h2pHeadquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. Were pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals. At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees. With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive. Were building on our rich history, and we believe our greatest achievements are ahead of us. If youre passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career!/ppPrincipal Medical Writer - Regulatory And Medical Writing Summary: The Principal 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 Executive Director (Head) of Regulatory and Medical Writing. 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 (including Marketing Application Module 2 summary documents), conducting quality control (QC) reviews, resolving Quality Assurance (QA) audit findings, and working with Regulatory Operations for publishing and submission. The Principal Medical Writer will be assigned to projects that require advanced regulatory writing expertise compared with a Senior Medical Writer. This position may be fully remote; however, preference will be given to San Diego-based applicants./ppResponsibilities: Working with the Executive Director, Regulatory and Medical Writing, collaborate with internal teams (e.g., Clinical Development and Biostatistics) to lead, write, and manage complex clinical regulatory documents (e.g., clinical study reports, Investigator Brochures, clinical study protocols, briefing documents, marketing application summary documents [Module 2], etc.). Serve as Medical Writing department lead on multiple project/core teams. Function as subject matter expert within the department for assigned therapeutic/product areas. Responsible for planning (in collaboration with Global Project Management) and leading cross-functional teams to meet timelines for deliverables. Lead complex scientific key messaging/storyboarding cross-functional meetings, ensuring the messages are clear and consistent within and across documents. 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). Manage review cycles for documents; schedule and lead data interpretation meetings, comment resolution meetings, and other document-related meetings. Perform quality control (QC) reviews as necessary. Interact with Quality Assurance (QA) to resolve audit findings for specific 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. Mentor junior writers as needed. Other duties as assigned./ppRequirements: Bachelors Degree required, advanced degree in a relevant scientific/clinical/regulatory field a plus. A minimum of 8 years of direct experience as a medical writer preparing regulated documents in the pharmaceutical industry. Marketing application experience (e.g., lead writer of Module 2.5, 2.7.3, or 2.7.4) required. Rare disease experience is a plus. Experience as lead writer of key documents included in major US and/or international regulatory submissions comprising, but not limited to, 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). In depth experience writing Safety sections of regulatory documents preferred. Ability to independently write and complete documents to completion. Extensive working knowledge of relevant FDA, EMA, and ICH guidelines, particularly ICH E3 and ICH E6. Experience mentoring junior writers a plus. Deep understanding of the drug development process. Strong ability to assimilate and analytically interpret scientific data. Experience preparing data tables and basic figures required. Proficient knowledge of American Medical Association (AMA) style guidelines. Advanced abilities to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy. Excellent attention to detail and time-management skills. Ability to balance multiple projects simultaneously. Technical expertise in typical Office applications (Microsoft Office, Adobe Acrobat). Experience working in Veeva and with StartingPoint templates is a plus. Ability to follow style guides, lexicons, and eCTD templates etc. Excellent written and oral communication skills with an ability to clearly present technical information within and across functional areas. Energetic, self-motivated, and a hands-on professional with a strong work ethic. Ability to work collaboratively in a dynamic environment. Strong desire and ability to be a team player, working and leading towards common goals. An ability to be productive and successful in an intense work environment. Personable and outgoing./p/div