Principal Medical Writer

Parexel; United States; Remote; USD 63.000 - 91.000; Vollzeit

Benefits dieser Stelle

Fully remote from Canada

Global projects and collaboration

Flexible work arrangements

Zusammenfassung

Parexel, a leading global clinical development partner, is seeking a Principal Medical Writer for a fully remote, Canada-based role. You will lead complex regulatory and clinical writing projects, coordinate cross-functional teams, and mentor colleagues to ensure high-quality deliverables across diverse programs.

Join a collaborative, impact-driven team that supports drug development worldwide. Excellent communication, project management, and regulatory writing expertise are essential for

Qualifikationen

• Bachelor’s degree in Life Sciences or related field.
• Strong understanding of clinical research, drug development, and applicable regulatory guidelines.
• Extensive experience preparing CSRs, IBs, and ICFs.
• Demonstrated experience managing complex medical writing projects.
• Knowledge of resource planning and productivity management.
• Proficiency in Microsoft Word; familiarity with SharePoint and Excel.
• Fluency in written and spoken English.

Aufgaben

• Lead clinical and regulatory writing with high scientific accuracy and regulatory compliance.
• Drive project leadership by coordinating multiple writers and cross-functional teams.
• Build trusted relationships with clients and internal partners to align expectations and deliverables.
• Mentor colleagues, share best practices, and drive continuous improvement in processes.

Kenntnisse

Bachelor's degree

Medical writing

Regulatory writing

Project leadership

English fluency

Ausbildung

Bachelor’s degree in Life Sciences or related

Tools

Microsoft Word

SharePoint

Excel

Jobbeschreibung

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.

• 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.