Senior Regulatory Medical Writer

Ionis Pharmaceuticals, Inc.•Boston, MA

31d•Remote

About The Position

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. Rare disease experience is a plus.
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.

Nice To Haves

advanced degree a plus.
Drug marketing application experience preferred.
Rare disease experience is a plus.
Experience with StartingPoint templates preferred.

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.