Associate Director, Medical Writing

LEXICON PHARMACEUTICALS; Bridgewater Township (NJ); Remote; USD 175,000 - 195,000; Full time

Job summary

Lexicon Pharmaceuticals, Inc. is seeking a collaborative, agile Senior Medical Writer to support the R&D and Quality/Regulatory groups, producing accurate, concise, compliant documents and acting as a subject-matter expert on writing processes and style guides.

The role is based in Bridgewater, NJ, The Woodlands, TX, or remote. Responsibilities include coordinating cross-functional teams, integrating data into reports and journal submissions, leading reviews of protocols and study reports, and

Qualifications

• Bachelor’s Degree in a scientific/healthcare field in which writing is a major component is required
• AMWA membership and ELS certification is a plus
• Minimum of five (5) years of medical writing experience in a CRO, medical communications company, pharmaceutical company or other medical/scientific setting
• Knowledge of the drug development and approval processes in the U.S. is required
• Prior experience authoring publications, protocols, CSRs, Non-clinical reports and related documents; IND and NDA modules and summaries and other regulatory documents
• Experience with oversight of external Medical Writers and deliverables is required
• Skilled and adept with Microsoft Word, Microsoft SharePoint, Endnote, Adobe Acrobat

Responsibilities

• Guiding and coordinating cross-functional collaborations with key company stakeholders to develop research, quality and regulatory documents
• Helping to integrate chemistry, manufacturing, non-clinical and clinical trial information and data into concise and compelling reports and summaries (conference presentations, abstracts, posters, and slides) and journal manuscript submissions
• Leading writing, editing, and cross functional review of clinical protocols, amendments, and clinical study reports, ensuring accuracy, clarity, completeness, and compliance with established formatting, content and style guidelines
• May serve in an oversight role in the assembly and/or QC of final study reports
• Overseeing external contractors including CROs in the authoring of Lexicon documents, including preparing concise and unambiguous requirements statements or SOWs
• Ensuring process consistency with Lexicon SOPs and applicable Lexicon standards for completeness, degree of detail, quality (including data accuracy) and style/formatting according to pre-agreed timelines
• Assisting in the development and maintenance of procedures and supporting documentation for the creation, review, and approval of documentation of Lexicon research activities, including, but not limited to, SOPs, templates, Word toolbars, work practices, best practices training guides and aids for Lexicon authors and reviewers
• Serving as the Protocol Review Committee (PRC) Coordinator, to ensure that all PRC-related materials are efficiently collected, reviewed, finalized, and retained according to Lexicon SOPs
• Serving as the Clinical Data Review Committee (CDRC) Coordinator
• Ensuring that all final versions of documents are filed in secure network locations, and, where needed, version controlled with correct access permissions and security
• Serving as a subject matter expert on processes and tools for organizing, writing, editing and reviewing research, development, quality and regulatory documents
• Maintaining, updating and providing training on the Lexicon Style Guide for authors and the Lexicon Reviewer Guide for reviewers
• Estimated Allocation of Effort: Authoring of documents: 40%, Reviewing of documents: 40%, Training: 10%, Other: 10%

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Associate Director, Medical Writing

Clinical Operations Full-Time Regular Associate Director Bridgewater, NJ, Bridgewater Township, NJ, US

Salary Range: $175,000.00 To $195,000.00 Annually

Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transforms 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 and ultimately impact the lives of patients. 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!

Lexicon Pharmaceuticals is currently recruiting for a collaborative, agile, results focused Senior Medical Writer to join our team in either in Bridgewater, New Jersey, The Woodlands, Texas, or remotely.

Job Summary:

The Senior Medical Writer will support the Research and Development Organization and the Quality and Regulatory Organization by facilitating the production of accurate, concise, accessible, and compliant documents for Lexicon research, development and regulatory activities. They will serve as a company subject matter expert on processes and tools for organizing, writing, editing and reviewing research, development, quality and regulatory documents.

Responsibilities include, but are not limited to:

• Guiding and coordinating cross-functional collaborations with key company stakeholders to develop research, quality and regulatory documents
• Helping to integrate chemistry, manufacturing, non-clinical and clinical trial information and data into concise and compelling reports and summaries (conference presentations, abstracts, posters, and slides) and journal manuscript submissions
• Leading writing, editing, and cross functional review of clinical protocols, amendments, and clinical study reports, ensuring accuracy, clarity, completeness, and compliance with established formatting, content and style guidelines
• May serve in an oversight role in the assembly and/or QC of final study reports
• Overseeing external contractors including CROs in the authoring of Lexicon documents, including preparing concise and unambiguous requirements statements or SOWs
• Ensuring process consistency with Lexicon SOPs and applicable Lexicon standards for completeness, degree of detail, quality (including data accuracy) and style/formatting according to pre-agreed timelines
• Assisting in the development and maintenance of procedures and supporting documentation for the creation, review, and approval of documentation of Lexicon research activities, including, but not limited to, SOPs, templates, Word toolbars, work practices, best practices training guides and aids for Lexicon authors and reviewers
• Serving as the Protocol Review Committee (PRC) Coordinator, to ensure that all PRC-related materials are efficiently collected, reviewed, finalized, and retained according to Lexicon SOPs
• Serving as the Clinical Data Review Committee (CDRC) Coordinator
• Ensuring that all final versions of documents are filed in secure network locations, and, where needed, version controlled with correct access permissions and security
• Serving as a subject matter expert on processes and tools for organizing, writing, editing and reviewing research, development, quality and regulatory documents
• Maintaining, updating and providing training on the Lexicon Style Guide for authors and the Lexicon Reviewer Guide for reviewers
• Estimated Allocation of Effort:
• Authoring of documents: 40%
• Reviewing of documents: 40%
• Training: 10%
• Other: 10%

Required Experience:

• Bachelor’s Degree in a scientific/healthcare field in which writing is a major component is required
• AMWA membership and ELS certification is a plus
• Minimum of five (5) years of medical writing experience in a CRO, medical communications company, pharmaceutical company or other medical/scientific setting
• Knowledge of the drug development and approval processes in the U.S. is required
• Prior experience authoring publications, protocols, CSRs, Non-clinical reports and related documents; IND and NDA modules and summaries and other regulatory documents
• Experience with oversight of external Medical Writers and deliverables is required
• Skilled and adept with Microsoft Word, Microsoft SharePoint, Endnote, Adobe Acrobat

For additional information about Lexicon and its programs, please visit 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 and verification of credentials before beginning employment.