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Associate Director, Medical Writing (Remote)

Employer
AbbVie
Location
United States
Start date
May 9, 2022

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Discipline
Clinical, Medical Writing
Required Education
Bachelors Degree
Position Type
Full time
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Job Details

  • Accountable for meeting the main objectives of clinical writing projects within established timelines, budgets; with an appropriate quality level for driving writing projects to timely completion and resolving conflicts, removing barriers and generating innovative ways to ensure teams achieve project goals.
  • Responsible for effective communication among team members and holding team members accountable to agreed-upon project dates.
  • Negotiate with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.) and manage the development of direct reports, including creating performance assessments, goals, and growth plans.
  • Assist in selection and supervision of agencies, freelance consultants, or other vendors while also, continually train/be compliant with all current industry requirements and provide leadership in the overall regulatory document strategy, working in collaboration with the Regulatory team.
  • Provide expertise in project management of multiple compounds and/or projects and interface with external groups (e. g, PK, Toxicology, e-Submissions, Regulatory, Statistical Support, Data Management, Publishing) to ensure accurate and timely completion/delivery of information and review of regulatory submissions.
  • Determine clinical writing resource needs by managing both internal and outsourced personnel and also external contracted medical writing resources ensuring department understands/complies with appropriate conventions, proper grammar and usage, and correct format requirements per ICH and other governing bodies by following established divisional guidelines, templates, and SOPs.
  • Supports scientific and marketing objectives in development; through coordination, preparation, and approval of scientific documents within the Global Project Team.
  • Provides oversight and project management of clinical writing projects within budget and in accordance with clinical and regulatory timelines by working closely with Global Project Teams and functional areas to develop project objectives and strategies and corresponding timelines and milestones.
  • Effectively utilize project management tools and techniques to drive multiple projects; responsible for overall project management for several projects simultaneously and build cross-functional relationships and lead team meetings to address specific projects.
  • Execute effective delegation, oversight and mentoring of permanent Abbott medical writers and contract writers working on multiple project teams while working directly with Global Project Heads, Assistant Directors, and Clinical Project Managers to develop/implement timelines to meet desired project completion dates.

Company

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Company info
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
 North Chicago
Illinois
60064
US
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