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Senior Medical Writer

Hybride
Niveau senior
CONTRACTOR

About the role

Job Title: Content Strategist – Regulatory Affairs Location: Mississauga, ON (Hybrid – 3 days onsite) Duration: Contract

About the Role We are seeking an experienced Content Strategist to support regulatory submissions for pharmaceutical products. The successful candidate will lead content strategy, coordinate cross-functional document development, and ensure high-quality regulatory documentation for global health authorities.

Key Responsibilities Lead content strategy for regulatory submissions and clinical documentation. Coordinate cross-functional teams to develop and review regulatory documents. Develop timelines and manage document authoring through submission. Ensure compliance with GxP, GCP, ICH, GVP, ISO, and applicable regulatory requirements. Review documents for scientific accuracy, consistency, and quality. Drive continuous process improvements and support global regulatory initiatives.

Required Qualifications Bachelor's degree in Life Sciences or a related field. 5+ years of pharmaceutical or biotechnology regulatory experience. Strong experience with clinical, safety, or device regulatory documentation. Knowledge of global drug/device development and regulatory guidelines (GxP, GCP, ICH, GVP, ISO, MDR/IVDR). Experience leading cross-functional teams and managing regulatory content projects. Excellent written and verbal communication skills. Experience with Microsoft Office, Google Workspace, Adobe Acrobat, and Veeva Vault.

Preferred Qualifications Experience supporting global regulatory submissions. Medical writing or regulatory content strategy experience. Ability to mentor junior team members.

Work Arrangement Hybrid role requiring 3 days per week onsite in Mississauga, Ontario.

Apply today if you have strong pharmaceutical regulatory documentation experience and are passionate about supporting global regulatory submissions.

About Pharmaceutical Company

Pharmaceutical Manufacturing
1,001-5,000 employees

None

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