Medical Writer & Document Quality Specialist at Lexicon Pharmaceuticals Inc

The Woodlands, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

01 Oct, 26

Salary

0.0

Posted On

03 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Medical Writing, Quality Control, Regulatory Writing, Document Development, Clinical Trial Documentation, Editing, Project Management, Technical Writing, MS Word, MS Excel, MS PowerPoint, Veeva Vault, StartingPoint, Interpersonal Communication, Attention To Detail, Time Management

Industry

Pharmaceutical Manufacturing

Description

Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through our unique approach to gene science based on Nobel Prize-winning technology, we are moving forward rapidly to bring innovative therapies to market. At Lexicon, our passion and dedication is driven by the patients for whom we work. Lexicon employees are inspired by the idea that their work can improve patients' lives and we know that our employees are essential to the success of our mission. Every day they bring their passion, talents and dedication to an engaging environment where they are rewarded with opportunities to realize their potential. We are dedicated to making Lexicon a great place to work by providing employees with the benefits, services, and programs as part of our total rewards package. Join our journey and be a part of our multitalented team and make a difference in patients’ lives! We are currently recruiting for a detail-oriented, team-focused Medical Writer with a focus in document quality control (QC). In this role, you will support the Lexicon across multiple functional areas including Clinical Operations, Medical Affairs, Regulatory Affairs, External Affairs, and CMC teams in document development, review, QC, and finalization of clinical trial documents, publications, presentations, and other regulatory documents. You will collaborate with multiple functional areas and outside vendors, such as clinical research organizations, to synthesize scientific and regulatory specifications into clean, consistent documents that align with Lexicon style guide, SOPs, and templates. You will conduct quality checks to verify factual information from document to source and ensure source documentation is available. We have offices in The Woodlands, Texas and Bridgewater Township, New Jersey. A remote working arrangement may be considered for the right candidate. Responsibilities include, but are not limited to: * 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. Qualifications: * 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 For additional information about Lexicon and its programs, please visit www.lexpharma.com [www.lexpharma.com]. Lexicon is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran. Lexicon Pharmaceuticals, Inc. is a drug-free workplace. Candidates are required to pass a drug test, background check, driving check (if applicable) and verification of credentials before beginning employment.

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Responsibilities

The role involves writing, reviewing, and performing quality control on clinical trial documents, publications, and regulatory submissions across multiple functional areas. The specialist will collaborate with internal teams and external vendors to ensure documents align with style guides, SOPs, and regulatory requirements.