Medical Writer Jobs

Position: Medical Writer

Location: Edmonton, Alberta

Term:Full-time, Permanent

Annual Salary Range: $80,000.00-$130,000.00 per year

Applied Pharmaceutical Innovation (API) brings life-saving research to the real world by helping life science innovators bridge the gap between academic research and commercial product development. We are driven, compassionate, and laser focused on making a dramatic positive impact with everything we undertake.

When you join API, you are part of a rapidly growing team that is creating collaborative opportunities to commercialize Canadian life sciences discoveries, increasing the amount of commercial research and development in the country, and supporting Alberta as a key pillar in Canada’s life sciences sector.

PLEASE NOTE: Applications submitted without a cover letter will not be reviewed.

The Position

We are seeking a skilled and experienced Medical Writer to join our team. As a Medical Writer, you will be responsible for creating high-quality, accurate, and engaging medical & scientific content. Your expertise will contribute to the development of various medical documents, including protocols, Investigator’s Brochures, clinical trial reports, regulatory submissions, scientific publications, marketing materials, and educational resources. The ideal candidate should possess a strong scientific background, exceptional writing skills, and the ability to communicate complex medical information in a clear and concise manner.

Key Responsibilities, include but are not limited to:

Accountability #1: Clinical Research/Academic Writing Support

• Provide appropriate and accurate interpretation of study results based on the provided background materials (e.g., study protocol, statistical analysis plan, Investigator’s Brochure, literature references) and statistical analysis output.
• Stay updated with the latest advancements in the medical field, emerging trends, and regulatory requirements to ensure the accuracy and relevance of the content produced.
• Write, edit, and proofread clinical study protocols, CSRs (full, abbreviated, or synoptic), statistical reports, integrated efficacy or safety summaries, patient narratives, briefing documents, clinical trial reports, manuscripts, abstracts, posters, slide decks, regulatory documents, and other medical documents in compliance with relevant guidelines and standards.
• Lead the content planning and production of written research findings (abstracts, manuscripts, systematic reviews, presentations, etc.) or regulatory documents (protocols, investigator brochures, clinical study reports, etc.) that aligns with established standards and guidelines.
• Collaborate with cross-functional teams, including medical experts, researchers, marketers, and regulatory affairs professionals, to gather necessary information and ensure the accuracy and clarity of medical content.
• Adapt complex scientific concepts and data into clear and concise language appropriate for the intended audience.
• Conduct comprehensive literature reviews and analyze scientific data to ensure the credibility and accuracy of the medical content produced.
• Maintain and organize reference materials, databases, and resources related to medical writing to support efficient and accurate content development.
• Develop and produce well-researched, accurate, and scientifically sound medical content for a wide range of purposes and audiences.

Accountability #2: Business Development Support

• Upon request, assist in the development of sales, and business development packages.
• Will be required to translate complex scientific information, theories, practicesand/or findings into clear, concise, and accurate language that can beunderstood by potential clients, sponsors and/or the general public.
• Provide editing services for conference,industry papers, and presentations.

Accountability #3: Publication Support

• Act as primary contact and liaison with Scientists/Investigators, Sponsors to select publication content, address content change requests, complete written revisions and/or resolve competing content requirements.

Accountability #4: Editorial Support

• Perform effective editing on assigned medical writing products to refine them, as much as possible and when time permits, before releasing them for internal and external review.
• Incorporate reviewers’ comments/input into the draft documents and deliver the revised documents for additional review cycle(s). Follow up on the quality control (QC) findings until they are properly addressed. Finalize documents for delivery to sponsors according to the established timelines.
• Upon request, support study teams with review, editing or proof-reading of external grant submissions, study documents or templates, such as charters, informed consent forms, or study plans (safety, statistical analysis, etc.).
• Perform peer review and QC for clinical documents developed by other Medical Writers, applying therapeutic area experience and scientific knowledge in the review and including QC checks for protocol-related information, accuracy of in-text numbers and source references, and consistency of document styles and formats.

Qualifications

Education

• Bachelor's degree in a scientific discipline (e.g., life sciences, pharmacy, medicine) is required. Advanced degree (MSc and/or Ph.D.) is preferred.

Professional Experience

• 5+ years of relevant experience in the field of medical/scientific writing.
• Proven experience working as a Medical Writer, preferably in a pharmaceutical, biotechnology, or contract research organization (CRO) setting.

Personal Competencies

• Experience in multiple therapeutic areas and Phase I through IV clinical trials an asset.
• Ability to work both independently and collaboratively within cross-functional teams.
• Strong understanding of medical terminology, clinical research concepts, and regulatory guidelines (e.g., ICH-GCP/ICH-E3 guidelines , Health Canada, FDA, EMA).
• Detail-oriented with exceptional organizational and time management skills to prioritize and meet deadlines while maintaining high-quality work.
• Familiarity with clinical trial design, data analysis, and statistical concepts is a plus.
• Strong analytical and critical-thinking skills to interpret and synthesize complex scientific data into meaningful content.
• Proficient in using scientific literature databases, citation management tools, and Microsoft Office suite.
• Excellent written and verbal communication skills, with the ability to effectively communicate complex medical information to diverse audiences.
• Fluent in written and spoken English.
• Familiarity with common style guides and publication guidelines (e.g., AMA, APA, CONSORT/SPIRIT) is highly desirable.

Additional Required Documents to Support Application

Cover letter & a writing portfolio are both required.

Examples of Writing Samples to include in your portfolio:

· Research-based documents and scientific papers

· Educational materials on new diseases

· Promotional materials on new drugs or scientific applications

· Safety narratives

· Content for websites focused on healthcare, life sciences, etc.

· Journal abstracts and manuscripts

Perks and Benefits at API

Comprehensive Health Coverage: At API, we prioritize the well-being of our employees. We offer a comprehensive health coverage plan. Our premiums are 100% covered, ensuring that you and your dependents receive the necessary healthcare support.

Professional Development Opportunities: We foster a culture of continuous learning and growth. API provides access to various professional development opportunities, including training programs, workshops, conferences, and certifications. We encourage employees to enhance their skills, broaden their knowledge, and stay updated with the latest advancements in the life sciences industry.

Collaborative and Inclusive Environment: At API, we believe in the power of collaboration and diversity. We foster an inclusive work environment that values and respects individuals from all backgrounds. We promote teamwork, open communication, and a supportive atmosphere where everyone's contributions are valued.

Generous Paid Time Off: We understand the importance of taking time off to recharge and maintain a healthy work-life balance. API offers a generous paid time off (PTO) policy that includes vacation days, medical/personal days, and holidays. We encourage our employees to prioritize their well-being and enjoy quality time away from work.

Green Transit Allowance: Employees based out of an office are eligible to enrol in our green transit program, which promotes the use of environmentally friendly modes of transportation. By participating in the program, you commit to making green transit your primary mode of transportation for at least 75% of your commute to and from work. Green transit includes walking, biking, carpooling, and public transportation.

How to Apply

Interested applicants must submit a resume and cover letter expressing their interest in the position and why they believe they are a strong candidate.

We appreciate the interest of all applicants but will only contact those selected for interviews.

Please send your cover letter and resume to Human Resources email: [email protected]