Associate Director, Regulatory and Medical Writer

Ionis•Carlsbad, CA

6d•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! ASSOCIATE DIRECTOR - REGULATORY AND MEDICAL WRITING SUMMARY: The Associate Director, Medical Writing is responsible for leading the planning, development, and delivery of complex clinical and regulatory documents in support of global regulatory submissions and development programs. This role provides strategic leadership within the Regulatory and Medical Writing function, serving as a key partner to Clinical Development, Biostatistics, and other cross-functional teams to ensure high-quality, scientifically rigorous, and compliant regulatory documentation. The Associate Director will lead medical writing activities across multiple programs, drive document strategy and messaging, and contribute to regulatory submission planning. This position may also mentor and guide other medical writers while ensuring consistency, quality, and adherence to regulatory standards. 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 in a scientific, clinical, or regulatory field preferred.
12+ years of medical writing experience in the pharmaceutical industry, including marketing applications (e.g., Module 2.5, 2.7.3, 2.7.4).
Proven lead writer experience for key regulatory documents (e.g., CSRs, protocols, IBs, INDs, NDAs, briefing documents), strong expertise in safety sections preferred.
Demonstrated experience leading medical writing activities for major regulatory submissions, including marketing applications.
Significant experience as lead writer for Module 2 summary documents (e.g., 2.5, 2.7.1, 2.7.2, 2.7.3, and 2.7.4) and other key regulatory documents.
Experience writing clinical study reports, Investigator Brochures, clinical protocols, IND/NDA sections, and regulatory briefing documents.
In depth experience writing Safety sections of regulatory documents preferred.
Strong understanding of the drug development lifecycle and regulatory submission processes.
Extensive knowledge of FDA, EMA, and ICH guidelines (especially ICH E3 and E6[R3]).
Demonstrated ability to lead cross-functional teams and manage complex document development projects.
Strong ability to interpret complex scientific and clinical data and translate it into clear regulatory narratives.
Proficiency in American Meical Association (AMA) style guidelines.
Advanced attention to detail with expertise in scientific editing, formatting, and document QC.
Technical proficiency with Microsoft Office and Adobe Acrobat, and document management systems such as Veeva.
Advanced written and verbal communication skills (including presentations), and project management skills, with the ability to clearly communicate complex scientific concepts across functional teams.
Extensive experience using style guides, lexicons, and eCTD requirements.
Demonstrated ability to mentor writers and contribute to a collaborative team environment.
Energetic, self-motivated, and able to thrive in a dynamic, intense, and fast-paced environment.
Strong team orientation with the ability to lead initiatives and drive results across cross-functional teams.
Advanced time-management skills.
Ability to balance multiple projects simultaneously.

Nice To Haves

Rare disease experience a plus.
Experience writing requests for regulatory designations (e.g., Breakthrough Designation, Orphan Drug, Sakigake, PRIME, etc) a plus.
Experience with StartingPoint templates preferred.

Responsibilities

Working with the Executive Director, Regulatory and Medical Writing, lead the development, authoring, and delivery of complex regulatory documents such as clinical study reports and marketing application summary documents (Module 2), and lead and/or contribute to Investigator’s Brochures, clinical study protocols, and briefing documents.
Serve as Regulatory Medical Writing lead on cross-functional program teams, partnering with Clinical Development, Regulatory Affairs, Biostatistics, Safety, and other stakeholders.
Provide strategic input into regulatory document planning and submission strategies to support global regulatory filings.
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 independently.
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) as document lead 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 and provide guidance to junior and senior medical writers, contributing to departmental best practices and writing standards.
Other duties as assigned.