Medical Writer

Responsibilities :

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