Senior Regulatory Medical Writer
Ionis Pharmaceuticals, Inc., Boston, MA, United States
Senior Regulatory Medical Writer
Position Summary
The Senior Regulatory Medical Writer will collaborate with internal teams to lead, write, and manage completion of clinical regulatory documents. This individual contributor reports to the Executive Director (Head) of Regulatory and Medical Writing and is responsible for the document lifecycle, including data interpretation meetings, key messaging, drafting content in accordance with US and international regulations, quality control reviews, resolving quality assurance audit findings, and coordinating with Regulatory Operations for publishing and submission.
This position may be fully remote; however, preference will be given to San Diego-based applicants.
Company Overview 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 and advance new approaches in gene editing.
Location San Diego, CA – remote work is an option; preference for San Diego-based candidates.
Responsibilities
Collaborate with internal teams (e.g., Clinical Development and Biostatistics) to lead and/or contribute to the writing and management of clinical regulatory documents (clinical study reports, marketing application summary documents [Module 2], Investigator’s Brochures, clinical study protocols, briefing documents, etc.).
Coordinate review cycles; schedule and lead data interpretation meetings, comment resolution meetings, and other document-related meetings.
Plan and meet delivery timelines in collaboration with Global Project Management.
Assimilate and interpret sources of information with appropriate guidance.
Ensure compliance with formatting conventions, grammar usage, and correct format requirements.
Perform QC reviews as necessary.
Interact with Quality Assurance to resolve audit findings for specific documents.
Represent the Medical Writing department on project/core teams.
Lead/contribute to key messaging and storyboarding cross‑functional meetings, ensuring consistency across documents.
Maintain expert knowledge of US and international regulations and guidance related to regulatory documentation.
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.
Requirements
Bachelor’s Degree required; advanced degree a plus.
Minimum of 5 years 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 leading and/or contributing to regulatory and clinical documents such as clinical study reports, Investigator’s Brochures, clinical study protocols, drug marketing application summary documents, IND applications, clinical sections of NDAs, and other regulatory documents; experience writing safety sections preferred.
Solid working knowledge of FDA, EMA, and ICH guidelines, particularly ICH E3 and ICH E6(R3).
Deep understanding of the drug development process.
Strong analytical skills to assimilate and interpret scientific data; experience preparing data tables and basic figures.
Proficient knowledge of AMA style guidelines.
Ability to locate 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, Adobe Acrobat, and document management systems such as Veeva.
Experience with StartingPoint templates preferred.
Ability to follow style guides, lexicons, and eCTD templates.
Excellent written, oral (including presentations), and project management skills.
Energetic, self‑motivated, hands‑on professional with a strong work ethic.
Ability to be productive and work collaboratively in a dynamic, intense, and fast‑paced environment.
Desire to be a true team player working toward common goals.
Willingness to ask for help when needed.
Benefits Ionis offers an excellent benefits package. For more details, see Ionis Benefits.
Compensation The pay scale for this position is $113,000 – $142,426.
Contact Please visit our website,
http://www.ionis.com
for more information about Ionis and to apply for this position; reference requisition #IONIS004004.
Important Notice NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Equal Employment Opportunity Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers. This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
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The Senior Regulatory Medical Writer will collaborate with internal teams to lead, write, and manage completion of clinical regulatory documents. This individual contributor reports to the Executive Director (Head) of Regulatory and Medical Writing and is responsible for the document lifecycle, including data interpretation meetings, key messaging, drafting content in accordance with US and international regulations, quality control reviews, resolving quality assurance audit findings, and coordinating with Regulatory Operations for publishing and submission.
This position may be fully remote; however, preference will be given to San Diego-based applicants.
Company Overview 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 and advance new approaches in gene editing.
Location San Diego, CA – remote work is an option; preference for San Diego-based candidates.
Responsibilities
Collaborate with internal teams (e.g., Clinical Development and Biostatistics) to lead and/or contribute to the writing and management of clinical regulatory documents (clinical study reports, marketing application summary documents [Module 2], Investigator’s Brochures, clinical study protocols, briefing documents, etc.).
Coordinate review cycles; schedule and lead data interpretation meetings, comment resolution meetings, and other document-related meetings.
Plan and meet delivery timelines in collaboration with Global Project Management.
Assimilate and interpret sources of information with appropriate guidance.
Ensure compliance with formatting conventions, grammar usage, and correct format requirements.
Perform QC reviews as necessary.
Interact with Quality Assurance to resolve audit findings for specific documents.
Represent the Medical Writing department on project/core teams.
Lead/contribute to key messaging and storyboarding cross‑functional meetings, ensuring consistency across documents.
Maintain expert knowledge of US and international regulations and guidance related to regulatory documentation.
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.
Requirements
Bachelor’s Degree required; advanced degree a plus.
Minimum of 5 years 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 leading and/or contributing to regulatory and clinical documents such as clinical study reports, Investigator’s Brochures, clinical study protocols, drug marketing application summary documents, IND applications, clinical sections of NDAs, and other regulatory documents; experience writing safety sections preferred.
Solid working knowledge of FDA, EMA, and ICH guidelines, particularly ICH E3 and ICH E6(R3).
Deep understanding of the drug development process.
Strong analytical skills to assimilate and interpret scientific data; experience preparing data tables and basic figures.
Proficient knowledge of AMA style guidelines.
Ability to locate 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, Adobe Acrobat, and document management systems such as Veeva.
Experience with StartingPoint templates preferred.
Ability to follow style guides, lexicons, and eCTD templates.
Excellent written, oral (including presentations), and project management skills.
Energetic, self‑motivated, hands‑on professional with a strong work ethic.
Ability to be productive and work collaboratively in a dynamic, intense, and fast‑paced environment.
Desire to be a true team player working toward common goals.
Willingness to ask for help when needed.
Benefits Ionis offers an excellent benefits package. For more details, see Ionis Benefits.
Compensation The pay scale for this position is $113,000 – $142,426.
Contact Please visit our website,
http://www.ionis.com
for more information about Ionis and to apply for this position; reference requisition #IONIS004004.
Important Notice NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Equal Employment Opportunity Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers. This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
#J-18808-Ljbffr