Remote Principal Medical Writer

Work at Home Job Source (https://www.workathomejobsource.com/) is now in search for a Remote Principal Medical Writer to work in the U.S. only.

JOB TYPE: MUST be a U.S. citizen.

RESPONSIBILITIES:

• Write, review, and edit clinical regulatory documents such as clinical study protocols, CSRs, Investigator’s Brochures, CTD clinical summaries and overviews, and other documents as required for submissions.
• Contribute to writing and editing of Briefing Documents and other regulatory submission documents; responses to regulatory agencies; and safety documents, such as DSURs, Risk Management Plans, and CSR safety narratives.
• Interpret statistical and clinical data with appropriate guidance/direction from teams and management.
• Arrange and conduct review meetings with teams and independently resolve document content issues and questions arising from the writing/review process.
• Work with cross-functional groups, including clinical research, biostatistics and drug safety, to set priorities for document preparation and collaborate on document content.
• Represent Medical Writing on project teams and advise on content and format requirements for various documents.
• Develop timelines and communicate writing process and timelines to team members.
• Interact with internal and external authors (as needed) and key stakeholders to develop high quality documents.
• Provide status/updates of Medical Writing deliverables to management, and create/track timelines.
• Contribute to document templates (e.g., protocols, CSRs) and style guides.
• Comply with established company policies and procedures, and industry and regulatory guidelines.
• Assist in the development of SOPs and Work Instructions for Medical Writing processes.
• Provide additional support to the Medical Writing team and the Clinical and Regulatory team as needed.
• Other duties as assigned.

QUALIFICATIONS/SKILLS:

• BA/BS in one of the life sciences with 8/+ years of scientific or medical writing experience at a biotech/pharmaceutical company.
• MA/MS/PhD degree is preferred.
• Knowledge of regulatory guidelines (e.g., ICH) and Good Clinical Practices (GCP).
• Ability to work both independently and in cross-functional team environments with minimal supervision.
• Ability to work effectively in a fast-paced environment with multiple high-priority projects.
• Project management skills.
• Strong written and verbal communication skills. Ability to engage and disseminate information among appropriate stakeholders for effective document production.
• Attention to detail with an ability to detect errors and inconsistencies in various types of documents.

JOB REQUIREMENTS: Computer, Internet, and a home office set-up.

PAY RANGE: $15.00-$90.00 per hour

TO APPLY FOR A PROFESSIONAL AT HOME AGENT POSITION:

To start your journey as a professional agent, kindly visit https://www.workathomejobsource.com/. Once there, click on the "Join Now" button and navigate to the Professional Work At Home Job Bank registry to become a valued member.

When submitting your resume, please remember to include the agent ID code WAHJSTanyaPhilip as a reference.