Job Title: Principal Medical Writer - Regulatory and Medical Writing
Job Location: Carlsbad, CA, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
Headquartered 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. We are pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With five currently marketed medicines for serious diseases and an expansive late-stage pipeline, we continue to build upon our groundbreaking innovations in science and technology to provide greater value to patients; and we 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 our success is a direct result of the exceptional talent 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 and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive. We are building on our rich history, and believe our greatest achievements are ahead of us. We invite you to apply and join us if you’re passionate about the opportunity to have meaningful impact on patients in need, our employees, and our organization. Experience and contribute to our unique culture while you develop and expand your career! PRINCIPAL 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, CA based applicants. Responsibilities Lifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
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