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Open nowFirst seen 4 days ago

Principal Med Writer

Lifelancer3,738 open roles

Where
Remote
Work mode
Remote
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Your applicationOpen nowPrincipal Med WriterLifelancer · Remote

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The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 57.8%60 days
This job: first seen 4 days ago

The posting

Job Title: Principal Med Writer

Job Location: Remote, India

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. As the lead writer, reviews documents for the team and provides training and guidance to junior team members. Provides advice on document development strategy, regulations and industry best practices. Demonstrates subject matter and therapeutic area expertise. Acts as backup program manager. Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.

Researches, writes, and edits clinical study reports and study protocols, and summarizes data from clinical studies.

Researches, writes, and edits clinical study reports and study protocols, and summarizes data from clinical studies.

- Serves as primary author who writes and provides input on complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.

- Provides senior level review of routine and complex documents. Provides training and mentorship for other writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.

- Ensures compliance with quality processes and requirements for assigned documents. As the subject matter expert, develops and reviews best practices, methods and techniques for achieving optimal results, including various client-specific processes, and leads process improvement initiatives. May also develop, review and manage performance metrics for assigned projects.

- May serve as backup program manager. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications, and assisting business development with client presentations and proposal text review and attending bid defense meetings and capabilities presentations.

- Represents the department at project launch meetings, review meetings, and project team meetings.

This job is curated by Lifelancer.

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

Please apply via Lifelancer platform to get connected to the application page and to find similar roles.

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