Associate Director, Medical Writing

Vertex Pharmaceuticals, Inc Boston , MA 02298

Posted 10 months ago

Job Description:

The Associate Director manages the overall operations of a team or major project and implements this through effective leadership. The Associate Director provides guidance and leadership for document development for regulatory filings and coordinates the clinical sections of more complex regulatory submissions, including organization, content, and resource requirements. The Associate Director applies advanced technical expertise and develops solutions to complex problems, fosters interdisciplinary understanding, and integrates Medical Writing department activities with those of other departments. This will be a full time role located in Boston, MA.

Key Responsibilities:

  • Collaborate with key stakeholders to ensure understanding of program strategy and the nature of medical writing services required to deliver on program objectives

  • Identify new technologies and initiatives related to the preparation of clinical documents, provide well-informed recommendations, and facilitate integration into department processes

  • Proactively anticipate risks, solve complex problems, and seek out and implement process improvements

  • Provide input to strategies and tactics for the Medical Writing department

  • Provide coaching and performance management

#LI-SO1

Minimum Qualifications

  • PhD (or equivalent degree) and 5+ years of relevant work experience
icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Principal Medical Writing Scientist

Vertex Pharmaceuticals, Inc

Posted 7 days ago

VIEW JOBS 1/21/2020 12:00:00 AM 2020-04-20T00:00 Job Description The Vertex Medical Writing department is a collaborative team responsible for supporting development programs throughout the product lifecycle. Medical Writers are key members of study teams and submission teams. The Principal Medical Writing Scientist is recognized as a scientific contributor and subject matter expert for clinical regulatory documentation. The Principal Medical Writing Scientist will interact with other medical writers, quality control reviewers, and cross-functional teams. KEY RESPONSIBILITIES: * Independently prepare clinical regulatory documents, including protocols, study reports, investigator's brochures, and sections of regulatory submissions * Participate in developing key messages for complex clinical regulatory documents * Provide medical writing input for study designs and statistical analysis plans * May be the lead writer for multiple clinical development programs or therapeutic areas * Provide expert review of documents * Proactively identify process and template improvements. * Provide expert-level input to cross-functional teams that work on standard operating procedures, process improvements, and integration of new tools and technologies * May train, mentor, and supervise staff in the Medical Writing department * Perform other duties as assigned TECHNICAL AND COMMUNICATIVE SKILLS: * Outstanding written communication skills * Extensive experience writing and editing clinical regulatory documents * Ability to analyze, interpret, and summarize highly complex data * Advanced understanding of drug development, clinical research, and regulatory requirements * Ability to form productive working relationships, and work through conflicts * Ability to prioritize and manage multiple complex projects Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com. Vertex Pharmaceuticals, Inc Boston MA

Associate Director, Medical Writing

Vertex Pharmaceuticals, Inc