Skip to main content

Search jobs

Search jobs

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Senior Medical Writer, Regulatory Strategic Writing

Req ID 2121101 Category Medical Division AbbVie

The Regulatory Strategic Writing (RSW) Senior Writer is responsible for providing support to one or more Therapeutic Areas (TA) as designated by RSW leadership. The Senior Writer provides support for the preparation and submission of critical regulatory documents (e.g. briefing books) and responses to health authority information requests using available reference materials such as documentation of previous interactions with healthcare authorities, clinical development documentation, scientific literature, and content provided by Global Regulatory Product Team (GRPT) team members. The Senior Writer is also responsible for ensuring the accuracy and quality of submission-ready documents using established RSW writing processes. The Senior Writer partners with the RSW TA lead, other RSW contributing staff, as well as the Global Regulatory Lead/Area Regulatory Lead to prepare high-quality, accurate and concise documentation supporting the objectives of GRPT teams and leadership.

Responsibilities:

  • Prepare, write, edit, and review high-quality, clearly-messaged documents founded in regulation and supported by the science for submission to regulatory agencies and health authorities. When necessary, serve as the RSW representative on project teams with the GRPT members, and functional area contributors (eg, Clinical, Pharmacovigilance, CPPM, etc.) and other RSW staff.
  • Participate in project management for compound programs and/or RSW projects and initiatives. Ensure accurate and timely completion/delivery of information and review of regulatory submissions. Communicate deliverables needed and corresponding writing processes, project timelines, and milestones to team members. In pursuit of this responsibility the Senior Writer is to work closely with GRPT members on the strategic content of target documents.
  • Understand, assimilate, and interpret sources of information (eg, scientific literature, internal and external studies, research documentation, charts, graphs, and tables, and previous interactions with healthcare authorities) with appropriate guidance/direction from GRPT team and/or authors/key opinion leaders. Ensure required documentation is obtained. Explain and prepare data in manner consistent with regulatory requirements. Confirm quality and completeness of information to be presented. Challenge conclusions when necessary. Convert relevant data and information into a form that meets regulatory document requirements. Ensure all regulatory electronic document deliverables are processed and compiled in alignment with timelines.
  • Assist with the coordination of the review, approval, QC, and other activities involved in the production of regulatory documents. Assist in the arrangement and conduct of review meetings with the team. Resolve document content issues and questions arising during the writing process.
  • Assist with regular communication with RSW leadership on timeline/milestone progress for any assigned program. Assess resource needs as timelines progress and communicate any additional resource requests to manger.
  • Understand/comply with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies by following applicable divisional guidelines, templates, and SOPs.
  • Assist in the design and implementation of tactical process improvements.
Qualifications:

Qualifications:

  • A Bachelor’s degree is required, either a Bachelor of Science, with significant relevant writing experience, or Bachelor of Arts in English or Communications with significant relevant science experience. A relevant advanced degree (e.g. MS, PharmD, PhD, MD) is preferred, and higher education may substitute for years of experience. American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Pharmaceutical Writing.
  • Minimum of 2 years of relevant industry experience in medical/regulatory writing in the healthcare industry or academia, or in a related area such as quality, regulatory, clinical research, or product support/R&D.
  • High-level content writing experience and experience with clinical development regulatory documents preferred, with working knowledge of statistical concepts and techniques. Excellent written and oral communication skills. Capable of assimilating and interpreting scientific content with adeptness in ability to translate for appropriate audience. Excellent attention to detail and superior ability with respect to consistency, clarity and accuracy.
  • Knowledge of US and international regulations, requirements and guidance associated with regulatory document preparation and submissions and ability to advise teams regarding compliance with regulations.
  • Knowledge of Common Technical Document content templates, electronic document management systems and information technology.
  • Excellent working knowledge of software programs in Windows environment.

Key Stakeholders:

  • RA management
  • Global Regulatory Product Team members and their associated Regulatory Leads
  • R&D functional management and members involved in generating regulatory submission documents
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)
Travel: No
Job Type: Experienced
Schedule: Full-time
ABBVIE

Most recent jobs

Sign up for job alerts

Join our talent network and receive AbbVie news and job alerts to your inbox.

Interested InPlease select a category or location option. Click “Add” to create your job alert.

Our Terms of Use, Cookie Policy and Privacy Policy explain how we collect and use information about you and the rights you have. By submitting your information, you acknowledge you have read those documents and consent to receive SMS communications and email jobs alerts from AbbVie.

Recently viewed jobs

You have not viewed any jobs recently.

Phishing scam alert

As an online job seeker, you could be a target of cyber (online) thieves seeking to secure personal information from you by sending you “phishing” messages.

Please be alert to and protect yourself from phishing scams. Find out how you can avoid being a victim of job phishing scams.

For Internal Candidates only - Notice of Filing of Labor Condition Application

Equal Employment Opportunity | Reasonable Accommodation