Allergan Associate Director, Medical Writing in Jersey City, New Jersey
Associate Director, Medical Writing
Jersey City, New Jersey, United States at http://agn.referrals.selectminds.com/jobs/607/other-jobs-matching/location-only
Sep 20, 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 Associate Director, Medical Writing is to lead and manage medical writing projects and manage Medical Writing staff in an assigned therapeutic area (TA) of Global Branded R&D (including, as appropriate, drugs, biologics, and devices). In this leadership position, the Associate Director, Medical Writing provides input into the hiring of staff and conducts performance evaluations of direct reports. The Associate Director, Medical Writing, undertakes writing assignments of key clinical study reports, briefing documents, or other priority clinical documents, and performs other writing tasks as appropriate. 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 Associate Director forecasts resource requirements for the assigned TA and is responsible to manage the budget. The incumbent performs budget updates and ensures the availability of adequate resources. The Associate 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 an assigned TA, the Associate Director is focused on clinical Medical Writing activities and deliverables across all projects, including quality control review and submission-readiness.
In this role, the Associate Director has responsibility 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. 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 an assigned therapeutic area [TA].
Serve as Medical Writing Lead for the designated TA 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 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.
Provide input into the hire of new Medical Writing staff. Train new staff and ensure staff adheres to Company systems and standards.
Lead the planning and management of the completion of clinical documents in the assigned TA.
Work in collaboration with management of all stakeholder departments to ensure timely delivery of quality clinical/regulatory documentation.
May perform as lead writer for key clinical study reports, briefing documents, or other priority clinical documents
Perform the Medical Writing review of selected documents from staff, contractors, or CROs, with focus on organization of content, clarity of text and tables, overall consistency, and appropriate use of English language/grammar.
Min. 8 years of medical writing experience required in clinical drug development in various therapeutic areas
Min. 2 years of experience as a lead writer of clinical study documents
Min. 2 years of supervisory experience managing projects or contracted writing; experience with supervision of direct reports preferred
Contribute to scientific/technical and medical writing reviews of documents (eg, Statistical Analysis Plan) for Biometrics, as needed.
Update protocol, clinical study report, and global regulatory submission document templates, as needed.
Author and update standard operating procedures other guidance, as needed.
Master’s Degree, other advanced degree, or equivalent experience required; PhD preferred.