Senior/Principle Medical Writer - Remote - Sponsor Dedicated

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel FSP is recruiting for an experienced Senior or Principle Medical Writer to join one of our key sponsors.

In this role you will be responsible for writing and overseeing the completion of a broad range of documents in support of company products and projects.

You will work with the lead and/or program medical writer and independently to develop messages and write, substantively rewrite, and edit documents for clarity and accuracy, ensuring high quality.

This individual will help manage project documents and timelines, as well as ensuring that documents comply with International Committee on Harmonization guidelines, SOPs, Good Clinical Practices, and Good Publication Practices.

Some specifics about this advertised role

• Write and edit clinical regulatory documents for clarity, and accuracy according to defined sponsor standards.
• Work with lead writer and project team to develop document messages and data presentations within submission timelines to meet company objectives.
• Provide writing support for a wide range of documents, including but not limited to investigator’s brochures, clinical study protocols and reports, integrated summaries, literature reviews, and SOPs.
• Ensure that documents comply with International Conference on Harmonisation guidelines, SOPs, and Good Clinical Practices.

Who are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

You’ll be an influential member of the wider team.

What we are looking for in this role

For every role, we look for professionals who have the determination and courage always to put patient well-being first.

That to us is working with heart.

Here are a few requirements specific to this advertised role.

• At least 6 years of writing experience in the pharmaceutical industry
• Ability to write and edit complex material to ensure accuracy and clarity,
• Experience with a variety of regulatory and clinical documents
• Experience in a matrix team environment
• Excellent written and oral communication skills and demonstrated problem-solving abilities
• Ability to handle multiple projects and short timelines
• Ability to work cooperatively with colleagues in a wide range of disciplines
• Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents