Director / Senior Director Medical Writer

Job Title : Director / Senior Director Medical Writer

Location : CST or EST candidates willing to work EST

Type : Direct Hire

Compensation : $165000 - $200000 annually

Contractor Work Model : Remote

As a Director or Senior Director, Medical Writer you will be responsible for document creation across clinical development and medical affairs. It is expected this will include the successful preparation of high quality, submission-ready regulatory documents, reports and protocols through implementation of the regulatory medical writing process in collaboration with cross-functional study teams. Your collaboration with the medical affairs team on publication strategy and execution, in alignment with applicable guidelines, will allow exemplary external representation of client and its products

Qualifications Bachelor’s degree required / Master’s or PhD preferred, preferably in a related scientific discipline

Minimum of 6+ years of pharmaceutical regulatory medical writing and 3+ years of scientific / academic writing experience, and ability to provide samples of both pharmaceutical and scientific writing experience.

Recent BLA experience from beginning to end; as well as prior managmetn experience

Outstanding interpersonal, written and oral communication skills, an ability to work in collaboration with a cross-functional study team, able to establish rapport with all functional leaders, experts and colleagues

Ability to multitask while driving towards critical deadlines on all projects

Superior attention to detail; ability to identify and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy in US- and UK-based English

Superior computer skills; experienced with MS Office (Word, Excel, PowerPoint, Outlook) and database applications. Preferably familiar with current electronic authoring, document management, and electronic regulatory submissions

System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref : #568-Clinical