Medical Writer - Katalyst Healthcares & Life Sciences

• Serves as medical writing lead on assigned projects. Works closely with in-function and cross-functional team(s) on project strategies. Implements all activities related to the preparation of writing projects
• Coordinates the review, approval, and other appropriate functions involved in the production of writing projects.
• Arranges and conducts review meetings with the team.
• Ensures required documentation is obtained.
• Converts relevant data and information into a form that meets project requirements.
• Explains data in manner consistent with the target audience(s) requirements.
• Effectively communicates deliverables needed, writing process, and timelines to team members.
• Holds team members accountable to agreed-upon project dates and with an appropriate quality level.
• Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands.
• Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or elevation as appropriate.
• Understands, assimilates, and interprets sources of information with appropriate guidance/direction from development teams. Interprets and explains data generated from a variety of sources.
• Verifies that results are consistent with protocols.
• Challenges conclusions when necessary. Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements, as needed for each writing project following applicable divisional guidelines, templates, and SOPs.
• Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to writing project.
• Works with journal/congress throughout the writing process, addresses questions/feedback, as appropriate, and works with team to draft responses as necessary.
• Knowledgeable of US and international regulations, requirements and guidance associated with preparation of writing projects. Learns and applies knowledge of therapeutic area and product to writing projects. Must continually train/be compliant with all current industry requirements as they relate to assigned projects , including submission/approval standards.
• Serves as a representative on project teams.
• Acts as Subject Matter Expert regarding computer-based technologies utilized by the respective departments.
• May mentor and provide guidance to more junior medical writers and/or external vendor/agencies. Implements tactical process improvements.

Requirements:

• Bachelor of Science required, with relevant writing experience, or Bachelor's degree in English or communications, with relevant science experience. Advanced degree preferred.
• American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical.
• 3 years relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, publications, clinical research, or product support/R&D.
• 3 years experience in experimental design and clinical/preclinical data interpretation preferred.
• Knowledgeable of US and international regulations, requirements and guidance associated with preparation of assigned writing projects.
• Knowledge and experience working with templates and relevant systems
• Excellent written and oral communication skills. Experience in working with collaborative, cross-functional teams, including project management experience.
• Ability to assimilate and interpret scientific content and translate information for appropriate audience.
• Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.
• Expert in word processing, flow diagrams, and spreadsheets. Excellent working knowledge of software programs in Windows environment.
• PhD preferred in science field or other advanced degree with scientific writing experience
• Excellent written and oral communication skills
• Word processing, flow diagram/figure development, graph creation expertise
• Fluent in Microsoft Word, Excel, Powerpoint