Medical Writer III, Medical Writing

Role Overview

• Writing or coordinating clinical and regulatory documents such as, but not limited to, CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents.
• Leading cross-functional (eg, with clinical team) document planning and review meetings.
• Interacting with cross-functional colleagues on document content and acting as a champion of medical writing processes and best practices.
• Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.
• Will function as a lead writer on most compounds (or submissions, indications, or disease areas) under supervision.
• Will be primary point of contact for medical writing activities for the cross-functional team (eg, clinical).
• Coach or mentor of more junior staff on document planning, processes, and content.
• Provides peer review as needed.
• Active participant in or lead of process working groups.

Requirements

• A university/college degree in a scientific discipline is required.
• An advanced degree (eg, Masters, PhD, MD) preferred.
• At least 6 years of relevant pharmaceutical/scientific; at least 4 years of relevant medical writing experience is required.
• Excellent oral and written communication skills are pivotal to engage in cross-functional discussions.
• English fluency required.
• Attention to detail.
• Able to function in a team environment.
• Strong project/time management skills.
• Strong project/process leadership skills.
• Able to resolve complex problems under supervision.
• Demonstrate learning agility.
• Able to build solid and productive relationships with cross-functional team members.

Benefits

• medical
• dental
• vision
• life insurance
• short
• and long-term disability
• business accident insurance
• group legal insurance
• consolidated retirement plan (pension)
• savings plan (401(k))
• Vacation
• up to 120 hours per calendar year
• Sick time
• up to 40 hours per calendar year; for employees who reside in the State of Washington
• up to 56 hours per calendar year
• Holiday pay, including Floating Holidays
• up to 13 days per calendar year
• Work, Personal and Family Time
• up to 40 hours per calendar year