Medical Writer I
1 week ago
**Position Overview**:
Our rapidly expanding team is seeking a **Medical Writer** **I **who can work for us on a full-time basis. The **Medical Writer I **is responsible for developing high-quality, scientifically valid clinical and regulatory documents for development of health products (dietary supplements, natural health products, pharmaceutical drugs and biologics) according to internal document standards and within project timelines.
**Primary Responsibilities**:
- Writes and integrates appropriate statistical and clinical data into protocols, investigator brochures, informed consent forms, clinical study reports, responses to regulatory questions and other clinical and regulatory documents
- Helps Medical Writer IIs manage the overall development and approval process for assigned documents within timelines, including document generation, initiation of review process, discussions on proposed revisions, and document completion in collaboration with other study team members
- Critically analyzes complex information and collaborates with clinical and statistical teams on data description, presentation and analysis
- Represents medical writing on project teams and actively participates in interactions including provision of scientific background information as needed
- Develops and maintains in-depth therapeutic and product area knowledge
- Provides quality control review of various regulatory and medical communications documents
- Promotes GXP compliance across the organization
- Other duties as required and as training and experience allow
- Maintains an attitude and philosophy consistent with the Company’s standards
**Core Competencies**:
- Demonstrated ability to produce clear, concise, and effective written and verbal communications describing scientific and clinical data in English
- Some experience in writing, editing, reviewing, and formatting clinical regulatory documents, or similar scientific documents (e.g., grants, manuscripts)
- Some understanding of clinical product development, clinical research, clinical study design, biostatistics, medical terminology, the regulatory environment including Health Canada/FDA/ ICH guidelines, and principles of GXP/ICH/CTD and other global standards
- Ability to work collaboratively and coordinate the efforts of team members to resolve comments and produce a final high-quality document
- Independently motivated with good problem-solving skills allowing analysis, synthesis and compilation of data from a broad range of disciplines
- Well-organized with demonstrated ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to timelines
- Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy
- Fluent in word processing, flow diagrams and spreadsheets
- Ability to critically review own work before sending out for internal/external review by team
- Ability to work in a fast-paced, cohesive, collaborative team-oriented work environment
**Qualifications**:
- BS/BA degree or equivalent experience in a scientific or health related field
- 1-2 years writing experience as a Medical Writer in the health care industry (e.g. medical/ regulatory/publication writing in the pharmaceutical/nutraceutical/biotech/device, medical communications, CRO or similar industries)
**Job Types**: Full-time, Permanent
**Benefits**:
- Dental care
- Extended health care
- Vision care
Schedule:
- 8 hour shift
Supplemental pay types:
- Bonus pay
Work Location: In person
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