Remote opportunity at
MMSPrincipal Medical Writer (Remote - Canada)
MMS is seeking a Principal Medical Writer to join its remote team in Canada on a full-time basis. This role suits professionals with extensive regulatory writing…
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About This Role
MMS is seeking a Principal Medical Writer to join its remote team in Canada on a full-time basis. This role suits professionals with extensive regulatory writing experience who want to contribute to clinical research projects within an award-winning clinical research organization. MMS provides scientific services to the pharmaceutical, biotech, and medical device sectors, specializing in complex trial data and regulatory submissions. In this position, the Principal Medical Writer independently evaluates…
Job Description
MMS is seeking a Principal Medical Writer to join its remote team in Canada on a full-time basis. This role suits professionals with extensive regulatory writing experience who want to contribute to clinical research projects within an award-winning clinical research organization. MMS provides scientific services to the pharmaceutical, biotech, and medical device sectors, specializing in complex trial data and regulatory submissions.
In this position, the Principal Medical Writer independently evaluates medical literature, authors complex clinical and regulatory documents, and leads writing assignments under minimal supervision. The role involves direct interaction with clients, managing project timelines, and mentoring other medical writers on the project team. Candidates should possess strong organizational abilities, expertise in clinical data interpretation, and proficiency in standard office software tools.
Responsibilities
- Critically evaluate and interpret medical literature for study design, scientific rigor, and statistical significance
- Author and edit clinical development documents including protocols, investigator brochures, clinical study reports, and integrated summaries
- Deliver writing assignments efficiently while maintaining workflow schedules and deadlines
- Provide customer service to internal and external stakeholders
- Communicate and coordinate project facets directly and independently with clients
- Contribute to or manage the production of interpretive guides
- Consult proactively with team members and department representatives to guide assignments
- Mentor other project team members and medical writers involved in the writing process
Requirements
- At least 6 years of previous regulatory writing experience
- Bachelor’s, Master’s, or PhD degree in a scientific, medical, clinical, or related discipline
- Substantial prior experience as a lead author for clinical study protocols
- Experience leading and managing teams while authoring regulatory documents under aggressive timelines
- Expertise in MS Word, Excel, PowerPoint, and related word processing tools
- Experience serving as a project lead or managing a project team
Qualifications
- Master’s or PhD degree in a scientific, medical, clinical, or related field
- Experience with regulatory submissions involving clinical study reports presented to regulatory authorities
- Understanding of clinical data
- Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines
- Experience with orphan drug designations and PSP/PIPs
Core Skills
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
Where is this job located?
This position is remote with a location designation of Canada.
What is the employment type?
The posting specifies a full-time employment type.
What education is required for this role?
A Bachelor's, Master's, or PhD degree in a scientific, medical, clinical, or related field is required, with a Master's or PhD being preferred.
Is the salary specified in the posting?
The job posting does not specify a salary.
When can applicants expect to hear back after submitting an application?
Applicants should consider their application unsuccessful if MMS does not reach out within 14 days of submission.
Sample Interview Questions
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