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Principal Medical Writer 1

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Merck Group

10d ago

  • Job
    Full-time
    Senior Level
  • Science
    Healthcare
  • Bangalore

AI generated summary

  • You need a relevant degree, 5-8 years in regulatory medical writing, strong project management skills, regulatory knowledge, and excellent English communication. Commitment to ethics and improvement is essential.
  • You will lead Medical Writing for marketed products, prepare clinical documents, coordinate external writers, ensure regulatory compliance, and contribute to best practices and process improvements.

Requirements

  • Bachelor’s degree in a scientific or writing discipline required; Master’s degree or Ph.D. preferred.
  • 5 to 8 years of regulatory medical writing experience, with a focus on post-marketing (non-) interventional studies.
  • Demonstrated ability to lead medical writing activities, including overseeing vendor resources and coordinating teams within a matrix organization.
  • Strong project management skills with proven ability to handle up to 50% project management responsibilities, ensuring efficient timeline and resource management.
  • Extensive knowledge of regulatory requirements and industry standards in medical writing, combined with proficiency in Microsoft Office and electronic document management systems.
  • Excellent verbal and written communication skills in English, essential for clear and effective collaboration and documentation.
  • Demonstrates a strong commitment to innovation, integrity, and excellence, along with a dedication to continuous improvement and adherence to ethical practices.

Responsibilities

  • - Play a pivotal role in leading the Medical Writing efforts for Marketed Products and Lifecycle Management, both globally and at regional/local levels.
  • - Independently prepare or oversee the preparation of clinical and regulatory documents such as Protocols, Clinical Study Reports, Investigator Brochures, or Clinical Summary documents.
  • - Support submissions for market approval/line extensions under minimal supervision.
  • - Oversee and coordinate other (external) writers assisting on documents under your responsibility.
  • - Ensure strict adherence to business objectives, company standards, as well as the organization of content, clarity of text and tables, overall consistency, and appropriate use of English language/grammar.
  • - Represent the department as a subject-matter expert on clinical study teams.
  • - Lead document-related meetings and review study-related documents.
  • - Ensure that all documents are produced according to agreed timelines, adhere to relevant SOPs, and meet the requirements of regulatory authorities and the company.
  • - Play a proactive role in contributing to the development and implementation of Medical Writing best practices and process improvements.

FAQs

What is the role of a Principal Medical Writer?

The Principal Medical Writer is responsible for leading Medical Writing efforts for Marketed Products and Lifecycle Management, preparing and overseeing clinical and regulatory documents, supporting submissions for market approval, and ensuring adherence to standards and timelines.

What qualifications are required for this position?

A Bachelor’s degree in a scientific or writing discipline is required, with a Master’s degree or Ph.D. preferred. Additionally, 5 to 8 years of regulatory medical writing experience is necessary.

Is project management experience necessary for this role?

Yes, strong project management skills are essential, with a proven ability to handle project management responsibilities effectively.

What type of documents will I be responsible for?

You will prepare or oversee documents such as Protocols, Clinical Study Reports, Investigator Brochures, and Clinical Summary documents.

Do I need to have knowledge of regulatory requirements?

Yes, extensive knowledge of regulatory requirements and industry standards in medical writing is required.

Will I be leading a team?

Yes, as a Principal Medical Writer, you will lead medical writing activities, oversee vendor resources, and coordinate teams within a matrix organization.

What skills are important for this position?

Excellent verbal and written communication skills in English, strong project management abilities, and a commitment to innovation and excellence are important for this position.

What opportunities does the company provide for personal development?

The company offers great opportunities for personal development and career advancement across the globe, promoting a diverse, inclusive, and flexible working culture.

Is experience with electronic document management systems required?

Yes, proficiency in Microsoft Office and electronic document management systems is part of the necessary qualifications for this role.

What is the company’s approach towards diversity and inclusion?

The company celebrates all dimensions of diversity and believes it drives excellence and innovation, creating access and opportunities for everyone to develop and grow.

Merck Group

We are Merck, a vibrant science and technology company. Science is at the heart of everything we do.

Manufacturing & Electronics
Industry
10,001+
Employees
1668
Founded Year

Mission & Purpose

This channel is not intended for U.S. and Canadian visitors. Merck operates in the U.S. and Canada as EMD Serono in Healthcare, MilliporeSigma in Life Science and EMD Electronics in Electronics. An unaffiliated and unrelated company, Merck & Co., Inc., Kenilworth, NJ, US holds the rights in the trademark MERCK in the U.S. and Canada. _______________________________ We are Merck, a leading global science and technology company headquartered in Germany. We are curious explorers, courageous pioneers, and ingenious inventors. Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Life Science, Healthcare, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and the planet. We believe in the positive power of science and technology. It has determined our actions since 1668 and inspires us to continue researching for a future worth living. As a family-owned company with over 350 years of experience, we stand for sustainability, responsibility, and innovative strength. We take pride in being a diverse and inclusive company that values and fosters the talents and abilities of our employees. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. Work your Magic and join Merck