Remote Medical Writer Part-Time – FEFA, LLC – Remote Part Time

FEFA, LLC is currently seeking a Part-Time Remote Medical Writer to assist with ensuring that the content, format, and structure comply with regulatory guidelines.

Compensation is based on several factors including but not limited to education, work experience, certifications, etc.

JOB DUTIES:

• Write, review, edit, and/or advise during the development of documents such as IND (Investigative New Drug) annual reports, protocols, Investigator’s Brochures, chemistry, manufacturing, and controls [CMC] information amendments, final study reports, Read-Ahead Packages for FDA meetings, meeting minutes, responses to FDA Requests for Information, and summary sections of INDs, MFs, IDEs, Biological License Application (BLAs), and New Drug Application (NDAs) in Common Technical Document (CTD) format.
• Interpret information into clear and concise scientific writing and apply applicable FDA regulations for the writing and publishing of regulatory submissions.
• Write, review, and edit multi-volume documents requiring advanced word processing and formatting, indexing, generation of a table of contents, and manual pagination according to FDA regulations.
• Write, review, and edit, electronic Common Technical Document (eCTD) submissions using knowledge of regulations and industry best practices for publishing.
• Ability to work collaboratively and coordinate the efforts of team members to resolve comments and complete deliverables.
• Ability to manage/prioritize multiple projects under general supervision, working in a fast-paced environment.
• Flexible and able to adapt to changing deadlines and priorities.

QUALIFICATIONS:

• Requires a Ph.D./PharmD in a medically relevant scientific discipline or a master’s degree with 4 years of relevant work experience.
• Minimum of 7 years in the pharmaceutical industry, and 3-5 years of medical writing experience. OOORRR At least 5-8 years of experience in medical or scientific writing in the pharmaceutical or biotech industry.
• Able to perform independently
• In-depth knowledge of the drug development, and approval processes, along with FDA and GCP principles.
• Proficiency in the use of Microsoft Office applications and experience working in electronic document management systems.
• Track record of developing high-quality clinical development and scientific documents
• Must be familiar with pharmaceutical terminology
• Understanding of chemical writing
• Strong written, verbal, and interpersonal communication skills
• Understanding of regulatory requirements and approval processes
• Ability to research information and sources to produce content
• Understanding of data management

FEFA, LLC is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

Job Types: Part-time, Contract

Schedule:

• Self-determined schedule

Experience:

• GCP: 5 years (Required)
• GLP: 5 years (Required)
• IND & NDA: 5 years (Required)

Work Location: Remote

Application response rate: 88%

Hiring 1 candidate for this role

Urgently hiring

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