Senior Regulatory Medical Writer

Ionis•Carlsbad, CA

2d•Remote

About The Position

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’re 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. We’re building on our rich history, and we believe our greatest achievements are ahead of us. If you’re 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! Senior Regulatory Medical Writer The Senior Regulatory 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. This role reports to the Executive Director (Head) of Regulatory and Medical Writing. This position may be fully remote; however, preference will be given to San Diego-based applicants.

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 pharmaceutical industry.
Drug marketing application experience preferred.
Experience writing, as lead and/or contributor, important regulatory and clinical documents such as clinical study reports (all sections including safety narratives), Investigator’s Brochures, clinical study protocols, drug marketing application summary documents, Investigational New Drug applications, clinical sections of New Drug Applications, and other regulatory documents (e.g., Briefing Documents) for submission.
Experience in writing Safety sections of regulatory documents preferred.
Solid working knowledge of relevant FDA, EMA, and ICH guidelines, particularly ICH E3 and ICH E6(R3).
Deep understanding of the drug development process.
Strong ability to assimilate and analytically interpret scientific data.
Experience preparing data tables and basic figures.
Proficient knowledge of American Medical Association (AMA) style guidelines.
Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy.
Excellent attention to detail in writing, editing, formatting, and document QC.
Excellent time-management skills.
Ability to balance multiple projects simultaneously.
Technical proficiency with Microsoft Office and Adobe Acrobat, and document management systems such as Veeva.
Experience with StartingPoint templates preferred.
Ability to 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 be productive and work collaboratively in a dynamic, intense, and fast-paced environment.
Desire and ability to be a true team player working toward common goals.
Willing to ask for help when needed.
A brief medical writing exercise may be requested at time of interview.

Nice To Haves

Rare disease experience is a plus.

Responsibilities

Working with the Executive Director, Regulatory and Medical Writing, collaborate with internal teams (e.g., Clinical Development and Biostatistics) to lead and/or contribute to the writing and management of clinical regulatory documents (e.g., clinical study reports, marketing application summary documents [Module 2], Investigator’s Brochures, clinical study protocols, briefing documents, etc.).
Coordinate the review cycles for documents; schedule and lead and/or contribute to data interpretation meetings, comment resolution meetings, and other document-related meetings.
Responsible for planning (in collaboration with Global Project Management) 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 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/contribute to 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.