Principal Clinical Regulatory Writer (Virtual Opportunities Available)
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 Principal Clinical Regulatory Writer is responsible for providing clinical regulatory document support to the clinical teams, ensuring successful preparation of high-quality submission-ready documents and effective implementation of the writing process. Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area. Interfaces with external groups (e.g. PK, Toxicology, eSubmissions, Regulatory, Statistical Support, Data Management, Clinical, Publishing) to ensure accurate and timely completion/delivery of information and review of clinical regulatory submissions. Serves as the scientific writing content expert for the department.
- Serves as medical writing lead on more complex clinical regulatory documents such as those associated with filings & dossiers. Works closely with the Regulatory team(s) on document strategies. Implements all activities related to the preparation and compilation of data and information into a single comprehensive package for new & updated clinical regulatory documents (US and ex-US).
- Serves as a subject matter expert within department for assigned therapeutic/product areas. As assigned, provides direction and guidance to medical writers regarding assigned projects, including review of work product. Provides input and feedback to management regarding internal medical writers' work product/quality. Recognizes potential scheduling and resource conflicts for projects across therapeutic area/product assignments and provides recommendations to resolve.
- Converts relevant data and information into a form that meets clinical regulatory document requirements. Explains data in manner consistent with clinical regulatory requirements. Coordinates the review, approval, and other appropriate functions involved in the production of clinical regulatory projects. Arranges and conducts review meetings with the team. Ensures required documentation is obtained.
- Responsible for effective communication among team members. Communicates deliverables needed, writing process, and timelines to team members. Holds team members accountable to agreed-upon project dates. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.). Must identify and resolve conflicts (including document content issues), remove barriers, generate innovative ways to ensure teams achieve project goals.
- Understands, assimilates, and interprets sources of info with appropriate guidance/direction from product teams and/or authors. Interprets and explains data generated from a variety of sources, including internal/external studies, research documentation, charts, graphs, and tables. Verifies that results are consistent with protocols. Confirms completeness of info to be presented. Challenges conclusions when necessary. Independently resolves document content issues and questions.
- Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies following applicable divisional guidelines, templates, and SOPs.
- Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to clinical regulatory documents.
- Works with Regulatory Quality Assurance throughout clinical regulatory document audit process, answers questions during the audit process (as appropriate) and works with team to draft responses as necessary.
- Maintains expert knowledge of US and international regulations, requirements, and guidance associated with clinical regulatory document preparation & submissions. Advises teams regarding compliance with clinical regulatory document content as defined in regulations. Must continually train/be compliant.
- Serves as a department representative on project teams. Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments (e.g. eDocs and eCTD databases). Coaches, mentors, and assists medical writers. Provides guidance to non-AbbVie medical writers and external vendors/agencies. Recommends, leads, and implements tactical process improvements, both within the department and division-wide.
POSITION MAY BE FILLED AT LEVEL COMMENSURATE WITH EXPERIENCE
- Bachelor of Science required, with significant relevant writing experience, or Bachelor's degree in English or communications, with significant relevant science experience. Masters or PhD in science discipline preferred with relevant writing experience.
- American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical.
- 4 years relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support/R&D.
- 2 years relevant industry experience preferred.
- 4 years’ experience in experimental design and clinical/preclinical data interpretation preferred.
- High-level content writing experience and experience with all types of clinical regulatory documents required. Expert in assimilation and interpretation of scientific content with adeptness in ability to translate for appropriate audience. Working knowledge of statistical concepts and techniques.
- Expert knowledge of US and international regulations, requirements and guidance associated with clinical regulatory document preparation & submissions and ability to advise teams regarding compliance with regulations. Knowledge and expertise with Common Technical Document content templates. Expert knowledge of current electronic document management systems and information technology.
- Excellent written and oral communication skills. Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.
- Expert in word processing, flow diagrams, and spreadsheets. Excellent working knowledge of software programs in Windows environment.
- Extensive experience in working with collaborative, cross-functional teams, including project management experience.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 5 % of the Time
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.