Medical Writer & Document Quality Specialist
About The Position
Lexicon is a biopharmaceutical company focused on pioneering medicines that transform patients’ lives through innovative gene science. The company is seeking a detail-oriented, team-focused Medical Writer with expertise in document quality control (QC). This role will support various Lexicon teams, including Clinical Operations, Medical Affairs, Regulatory Affairs, External Affairs, and CMC, in the development, review, QC, and finalization of clinical trial documents, publications, presentations, and other regulatory documents. The Medical Writer will collaborate with internal teams and external vendors to ensure documents are scientifically accurate, consistent with Lexicon's style guide, SOPs, and templates, and meet regulatory specifications. Quality checks will be performed to verify information against source documents.
Requirements
- Bachelor’s degree in healthcare or writing-related field required
- 5+ years technical or regulatory writing and/or QC experience; 2+ acceptable if in medical or regulatory writing
- Excellent QC skills.
- Excellent writing and editing skills.
- Excellent attention to detail—style, consistency, grammar, syntax, scientific accuracy
- Excellent interpersonal and oral communication skills.
- Ability to communicate with professionals from a variety of backgrounds
- Strong knowledge of MS Word, Excel, PowerPoint, and Outlook
- Ability to prioritize multiple projects
- Project/time management and organizational skills, as well as the ability to work independently
- Flexibility in meeting challenging deadlines and changing requirements while working on multiple projects
- Comprehensive Microsoft Office, especially Word but also PowerPoint and Excel skills, as well as internet skills
- Knowledge of current requirements and guidelines applicable to submission documents
Responsibilities
- Collaborating with functional areas to write, review, and QC documents including clinical study reports, protocols, Investigator Brochures, publications, presentations, and other clinical/regulatory documents for clarity, brevity, and consistency with the overall development program and source documents.
- Driving the document development process for the functional review team, including using medical writing templates and document management software (eg, StartingPoint and Veeva Vault).
- Synthesizing clinical data, information, references, and other sources with input from SMEs program team members to prepare and present data and document messaging consistent with regulatory requirements, guidelines, and program strategy.
- Reviewing and QCing documents
- Creating and managing document timelines
- Attending project-related meetings
- Assisting team members with document locations
- Developing and maintaining a Lexicon Style Guide
- Collaborating with vendors, which may include vendor oversight
- Identifying and appropriately communicating or escalating risks associated with document delivery or other writing-related issues.
- Completing project-specific and company training, as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
