|Top Tier Global Pharmaceutical company is expanding and has a need for three Principal (and Senior Principal) Medical Writers for their regulatory submissions. These are Full-time-employee positions- WORK FROM HOME- with strong compensation including full health, stock, bonus, long term and short term incentives and much more! This publicly traded global company is in a huge growth mode! |
Company plc (NYSE:XXX) is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Company is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world.
Company 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, Company 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 Company 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 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 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
Pr eferred Skills/Qualifications
- 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
Must possess highly developed skill/ability in the following:
- 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 strong management 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
- 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.
- RPh or RN is a plus