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Principal Medical Writer

Role overview

Summary

This role is for a Principal Medical Writer at Parexel, focusing on developing high-quality clinical and regulatory documents that support drug development programs. You will lead projects, mentor colleagues, and collaborate with cross-functional teams to enhance clinical research efforts.

Qualifications

  • Bachelor's degree in Life Sciences, Health Sciences, or a related discipline, or equivalent qualifications.
  • Strong understanding of clinical research, drug development, and applicable regulatory guidelines.
  • Extensive experience preparing clinical and regulatory documentation, particularly CSRs, IBs, and ICFs.
  • Demonstrated experience managing complex medical writing projects.
  • Fluency in written and spoken English.

Responsibilities

  • Research, develop, write, and edit high-quality clinical and regulatory documents.
  • Lead complex medical writing projects, ensuring scientific accuracy, regulatory compliance, and timely delivery.
  • Serve as a lead medical writer, submission coordinator, and primary client contact, as appropriate.
  • Share your expertise through mentoring, training, and knowledge sharing.

Key facts

Hard skills

Other skills

  • Writing
  • Editing
  • Microsoft Word
  • Microsoft Excel
  • Mentorship
  • Problem Solving
  • Negotiation
  • Communication
  • Adaptability
  • Collaboration

About the company

Parexel logo

Parexel

  • Clinical Research (CRO)
  • XLarge
  • 10,001+
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

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Job description

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.

Principal Medical Writer


Remote Opportunity | Canada


Bring Your Expertise. Lead with Purpose. Make an Impact.


At Parexel, we believe that behind every clinical trial is an opportunity to improve patients' lives.


As one of the world's leading providers of medical writing services, we bring together talented professionals who are passionate about advancing clinical research and accelerating the development of innovative therapies.


We're looking for an experienced Principal Medical Writer to join our global Medical Writing team in a fully remote, Canada-based role.


If you're passionate about scientific communication, enjoy leading complex projects, and thrive in a collaborative, global environment, this could be your next career opportunity!


Why Join Parexel?


At Parexel, your expertise makes a difference.

You'll have the opportunity to:

·         Make a meaningful impact: Contribute to clinical research that helps bring innovative treatments to patients worldwide.

·         Lead with expertise: Take ownership of complex medical writing projects and play a key role in regulatory documentation and submissions.

·         Collaborate globally: Partner with talented medical writers, cross-functional teams, and clients across the life sciences industry.

·         Influence and innovate: Share your knowledge, mentor colleagues, and contribute to continuous improvement.

·         Enjoy flexibility: Work remotely from Canada while contributing to meaningful global clinical development initiatives.


The Opportunity


As a Principal Medical Writer, you'll play a critical role in developing high-quality clinical and regulatory documents that support drug development programs.


Beyond writing, you'll have opportunities to lead projects, build strong client relationships, mentor colleagues, and help shape best practices across our Medical Writing organization.


What You'll Do


Lead Clinical and Regulatory Writing

·         Research, develop, write, and edit high-quality clinical and regulatory documents.

·         Lead complex medical writing projects, ensuring scientific accuracy, regulatory compliance, and timely delivery.

·         Prepare key clinical documents, including Clinical Study Reports (CSRs), Investigator's Brochures (IBs), and Informed Consent Forms (ICFs).


Drive Project Leadership and Collaboration

·         Serve as a lead medical writer, submission coordinator, and primary client contact, as appropriate.

·         Coordinate contributions from multiple writers and cross-functional stakeholders.

·         Manage project priorities, timelines, and deliverables while maintaining high-quality standards.


Build Relationships and Influence

·         Develop trusted relationships with clients and internal partners.

·         Collaborate with stakeholders to align expectations, resources, and project objectives.

·         Provide medical writing expertise to support proposals and new business opportunities.


Mentor and Innovate

·         Share your expertise through mentoring, training, and knowledge sharing.

·         Identify opportunities to improve medical writing processes, efficiency, and quality.

·         Contribute to a culture of collaboration, continuous learning, and innovation.


What You'll Bring


We're looking for an experienced medical writing professional who combines scientific expertise with strong project leadership and communication skills.


Experience and Expertise

·         Bachelor's degree in Life Sciences, Health Sciences, or a related discipline, or equivalent qualifications.

·         Strong understanding of clinical research, drug development, and applicable regulatory guidelines.

·         Extensive experience preparing clinical and regulatory documentation, particularly CSRs, IBs, and ICFs.

·         Demonstrated experience managing complex medical writing projects.

·         Knowledge of resource planning and productivity management.

·         Advanced proficiency in Microsoft Word and familiarity with document management systems, SharePoint, Excel, and related technologies.

·         Fluency in written and spoken English.


Skills That Set You Apart

·         Leadership: Ability to guide projects, collaborate across teams, and support the development of others.

·         Communication: Exceptional written, verbal, interpersonal, and negotiation skills.

·         Adaptability: Ability to navigate changing priorities, embrace new challenges, and quickly learn new processes and technologies.

·         Collaboration: Comfortable working in a global, matrixed environment with diverse teams and stakeholders.

·         Problem-Solving: Sound judgment, proactive thinking, and a solutions-oriented approach.

·         Client Focus: Ability to build trusted relationships, understand client needs, and deliver high-quality results.

·         Organization: Strong attention to detail and the ability to balance multiple projects and competing priorities.


About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry.


With more than 22,000 employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and help make research a care option for anyone, anywhere.


Our people are united by a shared purpose: improving patients' lives by accelerating the development of new therapies.


We embrace bold thinking, collaboration, and continuous improvement, empowering our teams to make a meaningful difference in clinical research.


Ready to Make Your Next Move?


Your expertise can help shape the future of clinical research.

If you're an experienced medical writer looking for an opportunity to lead meaningful projects, collaborate with talented professionals, and make an impact on patients' lives, we'd love to hear from you.


Join Parexel and help advance clinical research, With Heart®.


Apply today!

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