Top 6 Sr. technical writer (remote) Jobs in Wilmington, De

Manager, Medical Writer, Quality Control and Clinical and Regulatory Medical Writing (Remote)
Cabaletta Bio —Philadelphia, PA
- Remote
- Microsoft Word
- English
- Master's degree
- Health insurance
- Paid time off
Sr. Technical Writer (REMOTE)
Fairwinds Technologies, L —Middletown, DE
- $94,000 - $105,000 a year
- Full-time
- Remote
- Computer Science
- US work authorization
- Senior level
Quick Apply
3d
Senior Scientific Associate / Senior Medical Writer - Promotional Medical Writing (CST)
Precision AQ —Philadelphia, PA
- $75,000 - $122,500 a year
- Online Application
- Remote
- Bachelor of Science
- Research
- Mid-level
Quick Apply

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Sr. Technical Writer (REMOTE)
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3d
Senior Technical Writer
Contact Government Services, LLC —Philadelphia, PA
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sr. technical writer (remote) jobs near wilmington, de

Manager, Medical Writer, Quality Control and Clinical and Regulatory Medical Writing (Remote)

Cabaletta Bio
Philadelphia, PA

Apply Now

Job Details

Benefits

Stock options
Health insurance
Paid time off

Qualifications

Microsoft Word
Medical writing
Content creation for technical audiences
Biostatistics
Technical documentation
Presentations for conferences or internal meetings
English
ICH guidelines
Team training
Mentoring
Document viewing software
Technical training
Training & development
Technical writing experience within technology
Grammar Experience
Medical terminology

Full Job Description

About the Position

Reporting to the Senior Director, Clinical Medical Writing, the Senior Associate Medical Writer Quality Control Specialist will be a key member of the Regulatory Affairs and Clinical Development organization and interface with cell therapy clinical and regulatory personnel in the production of high-quality documentation that is appropriate for its intended audience (e.g. regulators, journal editors, NIH, clinical trial sites/investigators). The Medica/Regulatory writer works with Quality and Regulatory personnel to ensure compliance with US, EU, and ICH requirements

Responsibilities Include

Assists with writing and generation of clinical documentation (protocols, investigator brochures, informed consents) and regulatory designations (e.g. orphan drug applications, fast track, RMAT) for cell and gene therapy programs
Manages document preparation timelines and communicates with team members to maintain awareness of expectations, enable timely reviews, achieve milestones and document deliverables.
Reviews and edits documents including those authored by others
Ensures documents are finalized for submission including publishing readiness, quality checks and finalization of all supporting literature
Supports clinical trial readiness by working with clinical operations and CROs as needed for generation/review/editing of clinical study documentation including IRB/IBC communications/responses, study manuals, etc.
Maintains consistent high quality and efficiency in the generation of technical documentation to support regulatory filings
Works with clinical and translational teams to convert technical study data and results into reports in support of regulatory submissions.
Provides training and mentoring to subject matter experts on technical writing skills and best practices
Reviews and edits documents including those authored by others both internally and externally
Is a collaborative team player participating in both internal and external project team meetings as needed, and offers proactive solutions and advice to team members
Trains on company document management systems, authors and/or reviews departmental (clinical and regulatory) SOPs as needed
Performs other activities as assigned

Required Qualifications

Bachelors or masters degree in biological sciences; with 6 years’ experience or Ph.D. and 2 years’ experience in a technical writing capacity
Familiarity with the key requirements for regulatory submissions in ICH regions as stipulated in applicable regulations and guidelines for pharmaceuticals/biologics
Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IMPD, INDs, MAAs, NDAs, and BLAs, is preferred
Ability to critically analyze, synthesize, and present complex information in well-constructed documents
Working knowledge of drug/biologics development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology
Confidence to present to management, peers, and scientific or business collaborators
Ability to support multiple projects and to prioritize work independently
Ability to comply with company and/or industry style guides and templates
Ability to guide and train others in the writing of technical documentation
Fluent with written and spoken English with excellent attention to detail relative to consistency, grammar, syntax, and scientific accuracy
Advanced MS Skills in Word, Excel, and Adobe Pro
Strong team orientation and passion for continuous self-development.
Experience in the biotech industry or in a startup industrial setting is preferred.

How to Apply

Please click the link at the bottom of the posting to submit an application.

Benefits

Our most important asset is our people and we offer competitive benefits including health and retirement, PTO, and stock option plans.

Equal Opportunity Employer

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.

Apply Now

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sr. technical writer (remote) jobs in wilmington, de

Manager, Medical Writer, Quality Control and Clinical and Regulatory Medical Writing (Remote)

Sr. Technical Writer (REMOTE)

Senior Scientific Associate / Senior Medical Writer - Promotional Medical Writing (CST)

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