Remote Director of Medical Communications

Remote Director of Medical Communications needed for well-established, fast-growing, full service Bay Area CRO

This Jobot Job is hosted by Colin Callahan

Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume.

Salary $160,000 - $200,000 per year

A Bit About Us

Based in the Bay Area with offices in Australia, we are a longstanding and fast-growing full service Contract Research Organization focused on quality and exceptional service. We are a single source provider of an integrated full suite of clinical development services from Phase 1 through Phase 4, including project management, clinical monitoring, site and contract management, vendor management, data management, biostatistics, programming, drug safety, medical monitoring, medical writing, QA inspection readiness, as well as strategic consulting services.

What sets us apart our amazing team and the relationships we have built with our long and growing base of sponsors. We understand that solid partnerships are the foundation of every successful trial and we are passionate about producing the highest quality work in order to keep these partnerships strong and long-lasting.

We have an awesome, tight knit group that has worked together for a very long time. If you are a skilled and experienced Director of Medical Communications who wants to be a part of a special group that will value you and your work, we would love to speak with you right away

Why join us?

• Amazing team with an average of over 20 years of clinical research experience
• Extremely high employee retention rate - our people stay with us for the very long-term
• Strong compensation and excellent benefits
• Huge growth potential - we are growing

Job Details

Reporting to the Senior Vice President of Medical Communications, the person in this position analyzes and interprets scientific and medical data to reach conclusions, in addition to writing and preparing medical and scientific documents. This person also has sufficient leadership experience to lead writing teams, mentor other writers, and assist with managing resources on large writing projects.

Responsibilities

• Manage and direct a variety of project teams involving aspects of medical writing
• Direct, train, and assist other medical writers in the writing and editing of clinical and regulatory documents
• Write clinical documents including protocols, IBs, CSRs, patient narratives
• Write regulatory documents including INDs, eCTD/NDAs (including ISS and ISE summaries), Advisory Committee presentations, and briefing books
• Prepare scientific literature searches, abstracts, posters, and manuscripts
• Analyze and interpret clinical study data
• Lead document review and comment resolution meetings with cross-functional teams
• Participate in cross-functional team strategy discussions, which may include nonclinical, clinical, and regulatory strategies
• Budget preparations and resourcing for medical writing projects
• Budget and project tracking for medical writing projects

Requirements

• Demonstrated leadership capability
• Experience managing larger writing projects and/or writing teams
• Experience working on NDAs, BLAs, and other submission activities
• Experience mentoring/training other writers
• Exceptional oral and written communication skills
• Skilled at data analysis
• Strong understanding of drug development, clinical study design, regulations and scientific principles
• Able to build and maintain effective partnerships, both internally and with clients
• Able to manage time and expectations in a small group setting with limited/no administrative support
• Adapts work style to meet client and company needs
• Strong organizational abilities
• Motivated, self-directed, and able to work autonomously and in team settings to meet aggressive goals
• Dedicated to producing high-quality documents
• Available for minimal travel
• Excellent computer skills (Microsoft Office Suite) with advanced proficiency in MS Office (Word, Excel, and Outlook) required
• Ability to work in a collaborative and multi-disciplinary environment

Education

• BS, MS, RN, PharmD, or doctorate in a scientific or medical field
• A minimum of 10 years’ experience as a medical writer is required
• Experience in a pharmaceutical, biotechnology, or clinical research organization setting is required

Interested in hearing more? Easy Apply now by clicking the "Apply" button.