Senior Principal Medical Writer
Madison, New Jersey, United States
Research & Development
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women’s health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.
PLEASE NOTE: THIS POSITION CAN BE REMOTE BASED OR BASED IN MADISON, NJ.
The role of the Senior Principal Medical Writer is to prepare high-quality regulatory and clinical documents and to oversee medical writing responsibilities for multiple programs within an assigned therapeutic area (TA) of Global Branded R&D. In this position, the incumbent manages the planning and preparation of high-quality regulatory and clinical documents (eg, clinical study reports, briefing books, clinical protocols, integrated summaries) and ensures projects are in compliance with regulatory requirements, SOPs, business needs, and Company style/format and that they are delivered within predetermined timelines. Experience in the therapy areas of ophthalmology and CNS is desirable.
The Senior Principal Medical Writer may also undertake the role of Medical Writing Submission Lead for projects in a specified TA. In this leadership role, the incumbent is the primary interface with the cross-functional teams. The incumbent has a responsible role for assisting the Director of Medical Writing in forecasting resource requirements for Medical Writing deliverables for the assigned TA. In addition, the Senior Principal Writer, in the Submission Lead role, is the Medical Writing subject matter expert on clinical study teams or submission teams and works in collaboration with multiple cross-functional areas. The Medical Writing Lead manages the planning of assignments and evaluation of deliverables from contractors or other third-party vendors for medical writing deliverables.
Main Areas of Responsibilities:
- Serve as Medical Writing Program Lead for designated TA, working closely with the Clinical Leads, Clinical Scientists, Global Regulatory Lead, and other Clinical team members and Submission teams, as applicable, to gather the information (timelines; projects; documents) to forecast resource needs for medical writing deliverables in Global Branded R&D
- As Medical Writing Program Lead, track, prioritize, and manage team writing projects to provide input to the Director of Medical Writing of the designated TA regarding resources and budgeting requirements for assigned projects
- Serve as subject matter expert representing Medical Writing on cross-functional teams
- Train and mentor new staff and ensure staff adheres to Company systems and standards
- Prepare high-quality clinical documents including clinical study reports, briefing books, clinical protocols, and integrated summaries for regulatory submissions
- Perform the Medical Writing review of selected documents from staff, contractors, or CROs, with focus on adherence to business objectives and Company standards, as well as the organization of content, clarity of text and tables, overall consistency, and appropriate use of English language/grammar
- As Medical Writing Program/Document Lead, responsible for quality and adherence to established timelines for all Medical Writing deliverables in the designated TA. Independently lead clinical documents and manage/mentor MW resources
- Supervise medical writing or QC and formatting of other writers or contractors for assigned documents.
- More than 7 years of relevant medical writing experience required in clinical drug development or equivalent
- Experience as a lead writer of clinical study documents and global regulatory submissions and manager of medical writing projects
- Participate and/or lead in Operational Excellence initiatives in collaboration with the respective functions in Global Drug Development, as required.
- An understanding of clinical drug development, clinical trials, and global regulatory submission regulations is desired
- Knowledge of clinical operations, health sciences, and biostatistics is a plus
- Working knowledge of document management system (eg, Documentum)
- Proficient skills in Microsoft Word, Microsoft Excel, Microsoft Outlook, Adobe Acrobat are required
- Oral and written communication
- Demonstrated ability to understand and represent data clearly in written text
- Planning and organizing
- Decision making, judgment, and problem-solving
- Initiative and accountability
- Implementing and facilitating adherence to processes
- Promoting innovation and process improvement
- Effectively collaborates in a cross-functional environment to embody Allergan BOLD behaviors: Build Bridges, Power Ideas, Act Fast, Drive Results
- Maintaining and coordinating medical writing activities
- Interpersonal relationships, team building, motivating employees, and influencing others
- Developing people and staffing
- Professional leadership ability
Education: PhD or advanced academic degree strongly preferred; Master’s Degree or equivalent experience required