Director Medical Communications

Our client is a longstanding and fast-growing full-service Contract Research Organization focused on quality and exceptional service. 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 them apart is their 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.

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!!

100~ Employees, Over 25% growth the last two years!

FULLY REMOTE -- Maybe occasional/strategic travel as needed
COMPENSATION -- $175-225k+ base
Reports to SVP, Med Comm // Highly visible role

Basic Needs
* BS, MS, RN, PharmD, or doctorate in a scientific or medical field
* A minimum of 8+ years’ experience in medical communications (some medical writing experience preferred)
* Coming from CRO, pharmaceutical, biotechnology, or clinical research organization setting
* Oncology - Experience highly preferred!

Role
* Analyzes and interprets scientific and medical data to reach conclusions, in addition to writing and preparing medical and scientific documents.
* Leadership experience to lead writing teams, mentor other writers, and assist with managing resources on large writing projects

KEY RESPONSIBILITIES (but are not limited to the following)

• 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

PREFERRED KNOWLEDGE & SKILL REQUIREMENTS

• Leadership capabilities
• Managing larger writing projects and/or writing teams (mentoring/training other writers)
• Working on NDAs, BLAs, and other submission activities
• Exceptional oral and written communication skills
• Skilled in data analysis
• Thorough understanding of drug development, clinical study design, regulations and scientific principles
• Build and maintain effective partnerships, both internally and with clients
• Manage time and expectations in a small group setting with limited/no administrative support
• Driven to meet client and company needs, producing high-quality documents
• Organizational abilities
• Motivated, self-directed, and able to work autonomously and in team settings to meet aggressive goals
• Available for minimal travel (As strategically needed)
• Excellent computer skills (Microsoft Office Suite) with advanced proficiency in MS Office (Word, Excel, and Outlook) required
• Team player - work collaboratively and multi-disciplinary environment