Scientific Writer, R&D

Summary:

As a key member of Lumen’s pre-clinical development team, our Scientific Writer will be responsible for developing and authoring scientific, pre-clinical and regulatory documents and pre-clinical communications in support of Lumen’s drug development programs. As Lumen’s sole Scientific Writer, the successful candidate will also be a key leader in further developing Lumen’s scientific writing processes and infrastructure.

Essential Duties and Responsibilities:

• Develop, author and publish the following documents in collaboration with the pre-clinical R&D and clinical team:
  • Pre-clinical study reports
  • Reporting materials required under Lumen’s contractual agreements
  • Investigational New Drug (IND) applications and annual reports
  • Clinical protocols, clinical study reports, investigator brochures, informed consents, clinical trial disclosures
  • External communications, including peer-reviewed papers on pre-clinical and clinical results
  • Periodically, assisting with the drafting and review of grant applications
  • Depending on skills and aptitude, public reporting documents under federal securities laws
• Work closely with study teams to gain a comprehensive understanding of the data supporting document development to ensure that written work product is scientifically accurate, concise, and fully conforms to the relevant instructionsWorking closely with the study team to ensure that results and messages in clinical documents accurately reflect the data
• Participate in the strategic publication planning process and implementation of publication plans, including working with author groups to develop and author manuscripts, abstracts, and presentations for scientific congresses
• Teach other senior contributors in the organization about clear and persuasive writing, and tools for generating high-quality prose
• Develop and implement document templates, style standards, reference library, reviewer guidelines, and standard operating procedures to ensure consistent and high-quality deliverables
• Depending on experience and aptitude:
  • Developing and co-authoring statistical analysis plans (the prose component) in a manner that is intelligible to non-specialist audiences
  • Partnering with study biostatisticians in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents

Qualifications and Requirements:

• Education & Experience:
  • Bachelor’s degree in relevant scientific discipline; master’s degree or doctorate preferred
  • Minimum of 5 (MS/PhD) to 8 (BA/BS) years of experience in the biopharmaceutical research field
• Skills & Attributes
  • Expert-level knowledge of Microsoft Word, PowerPoint, and Adobe Acrobat.
  • Additional desirable education and experience:
    • Prior IND/NDA/BLA/MAA submission experience
    • Knowledge of FDA regulations, ICH guidelines, and Good Clinical Practices
    • Consideration for candidates with direct experience with gastrointestinal diseases
  • An active interest in the underlying science of the biology as needed to gain comprehensive understanding of the design, objectives, and results of the studies to enable accurate and effortless communication to our target audiences
  • Must have the ability to lead and prioritize multiple projects in a fast-paced environment with strong attention to detail and organizational skills
  • Commitment to quality and timely delivery of results

Physical Requirements:

• Sit for extended periods of time (2 or more hours)
• Occasionally lift or carry up to 20 kg