Principal Writer, Regulatory Strategic Writing (Remote)
About the position
The Principal Writer (PW) at AbbVie is responsible for providing regulatory strategic document expertise and support for various therapeutic areas. This role involves preparing and submitting critical regulatory documents, managing project timelines, and ensuring the accuracy and quality of submission-ready documents. The PW collaborates with cross-functional teams and leads the writing process to meet regulatory requirements, while also mentoring other writers and supporting staff.
Responsibilities
• Serve as the RSW lead representative on project teams by partnering with the GRPT including functional area contributors to prepare high-quality regulatory documents.
,
• Provide leadership and project management expertise for compound programs and/or RSW projects and initiatives.
,
• Ensure accurate and timely completion/delivery of information and review of regulatory submissions.
,
• Determine and communicate deliverables needed and corresponding writing processes, project timelines, and milestones to team members.
,
• Work closely with GRPT members on the strategic content of target documents.
,
• Ensure required documentation is obtained and explain data in a manner consistent with regulatory requirements.
,
• Confirm quality and completeness of information to be presented and challenge conclusions when necessary.
,
• Convert relevant data into a form that meets regulatory document requirements.
,
• Coordinate the review, approval, QC, and other functions involved in the production of regulatory projects.
,
• Arrange and conduct review meetings with the team.
,
• Independently resolve document content issues and questions arising during the writing process.
,
• Communicate regularly with RSW leadership on timeline/milestone progress for any assigned program.
,
• Assess resource needs as timelines progress and communicate any additional resource requests to department management.
,
• Understand and comply with appropriate conventions, grammar usage, and format requirements per ICH and other governing bodies.
,
• Proactively identify and implement tactical process improvements.
,
• Mentor and provide guidance and oversight to support staff including other participating writers and/or external vendor resources.
Requirements
• A Bachelor's degree is required, preferably in a relevant field such as Science, English, or Communications with significant relevant writing experience.
,
• A relevant advanced degree (e.g., MS, PharmD, PhD, MD) is preferred.
,
• Minimum of 4 years of relevant industry experience in medical/regulatory writing in the healthcare industry or academia.
,
• Minimum of 2 years of regulatory document project management experience with extensive experience in working with collaborative, cross-functional teams.
,
• High-level content writing experience and experience with clinical development regulatory documents required.
,
• Excellent written and oral communication skills.
,
• Expert in assimilation and interpretation of scientific content with the ability to translate for appropriate audiences.
,
• Superior attention to detail and ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy.
,
• Advanced knowledge of US and international regulations associated with scientific publications or regulatory document preparation and submissions.
Nice-to-haves
• American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Pharmaceutical Writing.
,
• Knowledge and expertise with Common Technical Document content templates and electronic document management systems.
Benefits
• Paid holidays
,
• Health insurance
,
• Dental insurance
,
• 401(k)
,
• Paid time off
,
• Vision insurance
Apply Now
The Principal Writer (PW) at AbbVie is responsible for providing regulatory strategic document expertise and support for various therapeutic areas. This role involves preparing and submitting critical regulatory documents, managing project timelines, and ensuring the accuracy and quality of submission-ready documents. The PW collaborates with cross-functional teams and leads the writing process to meet regulatory requirements, while also mentoring other writers and supporting staff.
Responsibilities
• Serve as the RSW lead representative on project teams by partnering with the GRPT including functional area contributors to prepare high-quality regulatory documents.
,
• Provide leadership and project management expertise for compound programs and/or RSW projects and initiatives.
,
• Ensure accurate and timely completion/delivery of information and review of regulatory submissions.
,
• Determine and communicate deliverables needed and corresponding writing processes, project timelines, and milestones to team members.
,
• Work closely with GRPT members on the strategic content of target documents.
,
• Ensure required documentation is obtained and explain data in a manner consistent with regulatory requirements.
,
• Confirm quality and completeness of information to be presented and challenge conclusions when necessary.
,
• Convert relevant data into a form that meets regulatory document requirements.
,
• Coordinate the review, approval, QC, and other functions involved in the production of regulatory projects.
,
• Arrange and conduct review meetings with the team.
,
• Independently resolve document content issues and questions arising during the writing process.
,
• Communicate regularly with RSW leadership on timeline/milestone progress for any assigned program.
,
• Assess resource needs as timelines progress and communicate any additional resource requests to department management.
,
• Understand and comply with appropriate conventions, grammar usage, and format requirements per ICH and other governing bodies.
,
• Proactively identify and implement tactical process improvements.
,
• Mentor and provide guidance and oversight to support staff including other participating writers and/or external vendor resources.
Requirements
• A Bachelor's degree is required, preferably in a relevant field such as Science, English, or Communications with significant relevant writing experience.
,
• A relevant advanced degree (e.g., MS, PharmD, PhD, MD) is preferred.
,
• Minimum of 4 years of relevant industry experience in medical/regulatory writing in the healthcare industry or academia.
,
• Minimum of 2 years of regulatory document project management experience with extensive experience in working with collaborative, cross-functional teams.
,
• High-level content writing experience and experience with clinical development regulatory documents required.
,
• Excellent written and oral communication skills.
,
• Expert in assimilation and interpretation of scientific content with the ability to translate for appropriate audiences.
,
• Superior attention to detail and ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy.
,
• Advanced knowledge of US and international regulations associated with scientific publications or regulatory document preparation and submissions.
Nice-to-haves
• American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Pharmaceutical Writing.
,
• Knowledge and expertise with Common Technical Document content templates and electronic document management systems.
Benefits
• Paid holidays
,
• Health insurance
,
• Dental insurance
,
• 401(k)
,
• Paid time off
,
• Vision insurance
Apply Now