Allergan Director, Medical Writing in Jersey City, New Jersey
Director, Medical Writing
Jersey City, New Jersey, United States at http://agn.referrals.selectminds.com/jobs/631/other-jobs-matching/location-only
Sep 23, 2016Post 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 pharmaceuticals and biologic products for patients around the world. Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular 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. Our success is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
Join one of the world’s fastest growing pharmaceutical companies!
At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.
The role of the Director, Medical Writing is to manage Medical Writing staff and lead medical writing projects pertaining to clinical drug development in assigned therapeutic area(s) of Global Branded R&D (including, as appropriate, drugs, biologics, and devices). In this leadership position, the Director, Medical Writing is responsible to hire, train, and develop, staff, and conduct performance evaluations. The incumbent is the primary interface with Clinical Development for assigned projects.
The incumbent directs the planning and preparation of high-quality clinical documents (eg, protocols, clinical study reports, briefing books, integrated summaries, IBs) in compliance with regulatory requirements, SOPs, business objectives and company style/format. The Director forecasts resource requirements across one or multiple therapeutic areas and is responsible to manage the budget, including performing budget updates, ensuring appropriate assignment of resources and approving invoices. The Director participates as an active leader for process improvements initiatives and works in collaboration with management of cross-functional areas within Global Branded R&D.
As the Medical Writing Lead for assigned therapeutic areas, the Director is focused on clinical Medical Writing activities and deliverables across all projects, including quality control review and submission-readiness.
In this role, the Director will be responsible for leading the planning and maintaining the clinical Medical Writing plan and for the development and maintenance of the budget requirements for clinical Medical Writing deliverables across assigned therapeutic areas. The Medical Writing Lead will manage 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 Writers or managers (direct reports and contract writers) in assigned therapeutic area(s) [TAs].
Serve as Medical Writing Lead for designated TA(s) and work 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
May be responsible to assemble and update the outsourcing budget for resourcing of Medical Writing deliverables across all global branded R&D medical writing TAs, with input from the MW Lead for individual TAs
May assume responsibility for contracting, accruals, and approval of invoices of contract medical writing across multiple TAs at the request of the Sr. Director, Medical Writing. Works with support staff to manage budget updates and accruals.
Recruit and provide input into the hire of new Medical Writing staff. Train new staff and ensure staff adheres to Company systems and standards.
At min. 10 years of medical writing experience required in clinical drug development in various therapeutic areas
Min. 2 years of supervisory experience of direct reports preferred
Experience as a lead writer of clinical study documents and global regulatory submissions and manager of medical writing projects
RPh or RN is a plus
Experience with resource planning and budget management is a plus
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 systems (eg, Documentum®)
Proficient skills in Microsoft Word, Microsoft Excel, Microsoft Outlook, Adobe Acrobat
Skills with Microsoft PowerPoint, Microsoft Project, Microsoft Visio are a plus
Must possess excellent skill/ability in the following:
• Oral and written communication
• Planning and organization
• Decision making, demonstrating good judgment, and problem solving
• Interpersonal relationships, coaching/mentoring, building teams. motivating staff, and influencing at a distance
• Recruiting and developing staff
• Taking initiative and demonstrating accountability
• Directing groups
Master’s Degree, other advanced degree, or equivalent experience required; PhD preferred