Scientific Writer Jobs in Seattle, WA at Lumen Bioscience

Title: Scientific Writer

Company: Lumen Bioscience

Location: Seattle, WA

Job Description

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

Essential Duties and Responsibilities

The major tasks for this position are as follows:

Develop, author and publish the following documents in collaboration with the clinical development team and the pre-clinical R&D team:
Investigational New Drug (IND) applications and annual reports
clinical protocols, clinical study reports, investigator brochures, informed consents, clinical trial disclosures
reporting materials required under Lumen’s grant funding arrangements
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
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
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 instructions
Develop and implement document templates, style standards, reference library, reviewer guidelines, and standard operating procedures to ensure consistent and high-quality deliverables
Working closely with the study team to ensure that results and messages in clinical documents accurately reflect the data
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

This job description is not designed to cover or contain a comprehensive listing of duties, activities, or responsibilities that are required of the employee. Other duties responsibilities, and activities may change or be assigned at any time with or without notice.

Desired Qualifications and Requirements

Education and 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
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 enteric 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
Strong attention to detail and organizational skills
High integrity and ethics
Commitment to quality and timely delivery of results

Physical Requirements
Sit for extended periods of time (2 or more hours)
Application Instructions

Please submit a resume and cover letter to [email protected] with the job title in the subject line.

This position is available immediately. Applications will be reviewed upon receipt. Only successful applicants will be contacted.

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About Lumen Bioscience