Senior Medical Writer, Regulatory Strategic Writing
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.
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.
- 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.
- 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.
- 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)
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.