Job Title: Medical Writer

Part Time: 20 hrs/week

Location: Seattle, WA - onsite

Expected Areas of Competence:

• Ability to develop a range of written materials such as detailed instructions for high level principles-based documents
• Demonstrated ability to write complex processes in a logical order using simplified language, creation of visual process flow diagrams, and information mapping techniques
• Strong GCP and ICH knowledge, including local/regional guidelines which are applicable to clinical research and the regulatory landscape
• Ability to effectively manage projects, escalate issues as necessary and meet key milestones
• Ability to lead and facilitate writing team meetings, that contribute to attaining team goals and resolving complex issues
• Ability to evaluate utility of documents and assemble content to ensure clarity for users (including those who are not native English speakers)
• Collaboratively work with Regulatory and Clinical colleagues to ensure any process changes resulting from the issuance of new or revised GCP/ICH Guidelines, regulations, and other guidelines applicable to clinical research are documented appropriately, in an appropriate format
• Work with autonomy and is able to able to negotiate and influence others without direct authority

Qualifications:

• Bachelor's degree with a minimum of 5-10 years' experience in global drug development
• Demonstrated knowledge of Good Clinical Practice (GCP) ICH
• Guidelines and applicable FDA regulations

Project Management

• Demonstrated ability to successfully manage competing deadlines and balance priorities while meeting or exceeding expectations
• Demonstrated ability to maintain a high level of productivity, accountability and energy
• Demonstrated success in managing project team effectiveness, through facilitation and presentation skills to a globally diverse audience

Document Development and Review:

• High level of writing competency, specifically in the appropriate use of grammar, syntax and organization of ideas on paper
• Provides close attention to detail and excellent follow up
• Ability to take very detailed information and distill it down to focus on key messages

Flexible thinker with a growth mindset

• Proactively use judgment and creativity to manage risk and uncertainty, and to anticipate the need for and implement contingency plans
• Affinity towards fully utilizing technology