We are seeking an experienced Regulatory Data and Content Professional (Senior Medical Writer) to lead the development and execution of regulatory content strategies for global submissions. This role is responsible for driving high-quality regulatory documentation across the product lifecycle, ensuring compliance with applicable regulations and internal standards, and collaborating with cross-functional teams to support successful interactions with global health authorities.
Location: Mississauga, Ontario, Canada
Lead the development and execution of regulatory content strategies for submissions to global regulatory authorities.
Manage and coordinate the preparation of clinical dossiers and safety documentation for pharmaceutical products and/or medical devices.
Develop content plans and timelines, ensuring alignment with overall project schedules.
Review regulatory documents for scientific accuracy, clarity, consistency, organization, and compliance with regulatory requirements.
Drive key messaging and content integration across submission documents.
Collaborate with cross-functional stakeholders to resolve content-related issues and ensure timely delivery of submission materials.
Contribute to continuous improvement initiatives, content standards, and implementation of new technologies and automation tools.
Maintain inspection and audit readiness for regulatory documentation processes.
Stay current with evolving regulatory guidelines, scientific developments, and therapeutic area knowledge.
Mentor and support less experienced content strategists and medical writers when applicable.
Bachelor’s degree or higher in Life Sciences or a related scientific discipline.
Minimum 5 years of experience in the pharmaceutical or biotechnology industry in regulatory writing, medical writing, or regulatory content management.
Demonstrated experience independently delivering complex regulatory documentation projects and leading cross-functional teams.
Strong knowledge of global drug and/or medical device development processes and regulations, including ICH, GCP, GxP, ISO, and MDR/IVDR guidelines.
Expertise in clinical and/or safety regulatory documentation throughout the product lifecycle, from early development through post-marketing activities.
Proven ability to analyze and synthesize complex non-clinical and clinical data from multiple disciplines.
Experience supporting or leading global regulatory filings is strongly preferred.
Excellent communication, stakeholder management, and conflict-resolution skills in matrixed global environments.
Strong project planning and organizational skills with high attention to detail.
Proficiency with Google Workspace (G Suite), Microsoft Office Suite, Adobe Acrobat, and Veeva Vault.
Fluent in English (written and spoken).
Experience with regulatory submissions for both pharmaceuticals and medical devices.
Familiarity with GVP principles and safety reporting requirements.
Experience with structured content authoring, content reuse strategies, and next-generation regulatory technologies.
- Prior mentoring or people-lead experience within a regulatory writing or content strategy function.
Expected Compensation Range:
90K. The final compensation offered will be determined based on the candidate’s level of experience, skills, and qualifications, in compliance with applicable pay transparency requirements.
Canadian Experience Requirement:
No Canadian work experience is required for this position. Candidates are encouraged to apply regardless of previous Canadian experience.
Artificial Intelligence (AI) Disclosure:
No Artificial Intelligence (AI) tools are used in the screening, assessment, or selection of candidates for this position. All stages of the recruitment process are conducted by human recruiters and hiring managers.
Statement Regarding Job Vacancy:
This position is a Job creation, created to support ongoing project needs.
Recruitment Process & Feedback Timeline:
Candidates will receive feedback on their application within a maximum of 45 days from the date of application or from their most recent interview stage.
Why choose us
- An international community bringing together more than 110 different nationalities
- An environment where trust is central: 70% of our leaders started their careers at the entry level
- A strong training system with our internal Academy and more than 250 modules available
- A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)
Amaris Consulting promotes equal opportunities. We are committed to bringing together people from diverse backgrounds and creating an inclusive work environment. In this regard, we welcome applications from all qualified individuals, regardless of sex, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.
At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!
