Medical Writer I
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Position Title: Medical Writer
Describe the primary goals, objectives or functions or outputs of this position.
Responsible for providing regulatory document support to the clinical teams, ensuring successful preparation of high quality submission-ready documents and effective implementation of the clinical writing process. Provides expertise in the medical writing for multiple compounds and/or projects within a therapeutic area or potentially across a therapeutic area. Interfaces with external groups (e.g. PK, Toxicology, eSubmissions, Regulatory, Statistical Support, Data Management, Publishing) to ensure accurate and timely completion/delivery of information and review of regulatory submissions. Participates in process improvement activities.
- Implements all activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated regulatory documents (US and ex-US). Develops a strong knowledge of US and international regulations, requirements and guidance associated with document preparation and submissions.
- Serves as the Medical Writing representative on project teams. Communicates deliverables needed, writing process, and timelines to team members. Ensures all electronic document deliverables are processed and compiled in alignment with timelines.
- Understands sources of information. Seeks out information to ensure complete documentation of all inputs. Converts relevant data and information into a form that meets regulatory document requirements. Interprets and explains data generated from a variety of sources, including internal and external studies, research documentation, charts, graphs, and tables.
- Verifies that results are consistent with protocols. Explains data in manner consistent with the target audience and regulatory requirements. Challenges conclusions when necessary.
- Confirms completeness of information to be presented. Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies by following established divisional guidelines, templates, and SOPs.
- Arranges and conducts review meetings with the team. Acts as interface to resolve issues and questions arising during the writing process.
- Performs literature searches as needed for drafting document content.
- Acts as eDocs Peer Advisor/Subject Matter Expert for assigned clinical teams.
- Works with manager throughout the RQA document audit process and works with team to draft responses as necessary.
- Participates in process improvement activities.
- Bachelor of Science required, with relevant writing experience, or Bachelor's degree in English or communications, with relevant science experience.
- May have 1+ years relevant industry experience in medical writing or in a related area such as quality, regulatory, clinical research, or product support/R&D.
1-2 years experience as a medical writer in the health care industry preferred. 1-3 years experience in experimental design and clinical/preclinical data interpretation preferred.
- •Developing knowledge of international regulations, requirements and guidance associated with document preparation and submissions.
- •Developing knowledge with CTD content templates. Developing knowledge of current electronic document management systems and information technology.
- •Excellent written and oral communication skills.
- •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. Recognizes potential scheduling and resource conflicts for project and provides recommendations to resolve.
- •Experience in working with collaborative, cross-functional teams, including project management experience. Acts as interface to resolve issues and questions arising during the writing process. Identifies issues impacting team alignment across responsible functional areas and implements resolutions to resolve team discord.
- Microsoft Office Experience