Principal Medical Writer - Regulatory and Medical Writing
Principal Medical Writer - Regulatory and Medical Writing
Posted on :
20-01-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
20-01-2025
Job Description
Job Title: Principal Medical Writer Regulatory and Medical Writing
Job Location: Carlsbad CA USA
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior 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 RNAtargeted 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 latestage 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 crossfunctionally 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
Please visit our website for more information about Ionis and to apply for this position; reference requisition #IONIS003498
Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits
Full Benefits Link: %20Applicants%C2%A0%C2%BBBenefitsEmployees%20are%20rewarded
The pay scale for this position is $126339 to $160340
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals Inc. and all its subsidiaries are proud to be EEO employers.
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 crossfunctionally 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
- Working with the Executive Director Regulatory and Medical Writing collaborate with internal teams (e.g. Clinical Development and Biostatistics) to lead write and manage complex clinical regulatory documents (e.g. clinical study reports Investigator Brochures clinical study protocols briefing documents marketing application summary documents Module 2 etc.).
- 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 crossfunctional teams to meet timelines for deliverables.
- Lead complex scientific key messaging/storyboarding crossfunctional meetings ensuring the messages are clear and consistent within and across documents.
- 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).
- Manage review cycles for documents; schedule and lead data interpretation meetings comment resolution meetings and other documentrelated meetings.
- Perform quality control (QC) reviews as necessary.
- Interact with Quality Assurance (QA) 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 ontime preparation and publication of regulatory submission documents.
- Support Global Regulatory Lead with preparing information/responses requested by regulatory agencies.
- Mentor junior writers as needed.
- Other duties as assigned.
- Bachelor’s Degree required advanced degree in a relevant scientific/clinical/regulatory field a plus.
- A minimum of 8 years of direct experience as a medical writer preparing regulated documents in the pharmaceutical industry. Marketing application experience (e.g. lead writer of Module 2.5 2.7.3 or 2.7.4) required. Rare disease experience is a plus.
- Experience as lead writer of key documents included in major US and/or international regulatory submissions comprising but not limited to clinical study reports (all sections including safety narratives) Investigator Brochures clinical study protocols marketing application summary documents Investigational New Drug applications clinical sections of New Drug Applications and other regulatory documents (e.g. Briefing Documents).
- In depth experience writing Safety sections of regulatory documents preferred.
- Ability to independently write and complete documents to completion.
- Extensive working knowledge of relevant FDA EMA and ICH guidelines particularly ICH E3 and ICH E6.
- Experience mentoring junior writers a plus.
- Deep understanding of the drug development process.
- Strong ability to assimilate and analytically interpret scientific data. Experience preparing data tables and basic figures required.
- Proficient knowledge of American Medical Association (AMA) style guidelines.
- Advanced abilities to find and correct errors in spelling punctuation grammar consistency clarity and accuracy.
- Excellent attention to detail and timemanagement skills. Ability to balance multiple projects simultaneously.
- Technical expertise in typical Office applications (Microsoft Office Adobe Acrobat). Experience working in Veeva and with StartingPoint templates is a plus.
- Ability to follow style guides lexicons and eCTD templates etc.
- Excellent written and oral communication skills with an ability to clearly present technical information within and across functional areas.
- Energetic selfmotivated and a handson professional with a strong work ethic.
- Ability to work collaboratively in a dynamic environment.
- Strong desire and ability to be a team player working and leading towards common goals.
- An ability to be productive and successful in an intense work environment.
- Personable and outgoing.
Please visit our website for more information about Ionis and to apply for this position; reference requisition #IONIS003498
Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits
Full Benefits Link: %20Applicants%C2%A0%C2%BBBenefitsEmployees%20are%20rewarded
The pay scale for this position is $126339 to $160340
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals Inc. and all its subsidiaries are proud to be EEO employers.
/jobs/view/b570a980be0999cffd73f809f48db59c
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
