Allergan Principal Medical Writer in Madison, New Jersey
Principal Medical Writer
Madison, New Jersey, United States at https://agn.referrals.selectminds.com/jobs/5629/other-jobs-matching/location-only
▾ ▸ 1 additional location
Jun 07, 2018Post Date
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.
The role of the Principal Writer, Medical Writing, is to prepare high quality clinical documents and to oversee medical writing responsibilities for multiple programs within an assigned therapeutic area (TA) of Global Branded R&D (including, as appropriate, drugs, biologics, and devices). In this position, the incumbent manages the planning and preparation of high-quality 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.
The Principal Writer, Medical Writing may also undertake the role of Medical Writing Lead for all projects in a specified TA. In this leadership role, the incumbent is the primary interface with Clinical Development. The incumbent has a responsible role for forecasting and development of budget requirements for Medical Writing deliverables for the assigned TA. In addition, the Senior Principal Writer, in the 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
Supervise medical writing of other Medical Writers or contractors for assigned documents in the designated therapeutic area (TA)
Serve as Medical Writing Lead for designated TA, working closely with the Clinical Leads, Clinical Scientists, other Clinical team members and Submission teams, as applicable, to gather the information (timelines; projects; documents) to forecast and budget resource needs for medical writing deliverables in Global branded R&D
Assemble and update the budget for medical writing deliverables in the assigned TA, with the support of the Senior Director, Medical Writing or designee
Review documents as Medical Writing Lead for programs within a designated TA
Serve as subject matter expert representing Medical Writing on cross-functional teams
Participate in selecting medical writers (primarily external). 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 organization of content, clarity of text and tables, overall consistency, and appropriate use of English language/grammar
As Medical Writing Lead, responsible for quality and adherence to established timelines for all Medical Writing deliverables in the designated TA
Min. 8 years of medical writing experience required in clinical drug development in various therapeutic areas, or equivalent experience in academia or industry
At least 2-3 years of supervisory experience preferred
Experience as a lead writer of clinical study documents and global regulatory submissions and manager of medical writing projects
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
Skills in Microsoft PowerPoint, Microsoft Project, Microsoft Visio are a plus
Must possess highly developed skill/ability in the following:
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
Must possess strong management skill/ability in the following:
Assigning, reviewing, and planning medical writing assignments for in-house or contracted staff
Maintaining and coordinating medical writing activities
Participating in performance evaluations
Participating in the selection and training of new employees
Interpersonal relationships, team building, motivating employees, and influencing others
Developing people and staffing
Professional leadership ability
Master’s Degree, other advanced degree, or equivalent experience required; PhD preferred.
Licensure/Credentials:RPh or RN is a plus.
Equal Employment Opportunity Employer
Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.