📌 Core Information
🔹 Job Title: Medical Regulatory Writer
🔹 Company: Healx
🔹 Location: Cambridge, Ontario, Canada
🔹 Job Type: Full-time
🔹 Category: Biotechnology Research
🔹 Date Posted: 2025-04-03
🔹 Experience Level: 2-5 years
🔹 Remote Status: Hybrid (Office-based with flexible remote work)
🚀 Job Overview
Key aspects of this role include:
- Creating high-quality, accurate, and compliant documentation for regulatory submissions
- Translating complex scientific and clinical data into clear, accessible narratives for diverse audiences
- Collaborating with cross-functional teams to ensure critical information is communicated effectively
- Contributing to strategic decision-making and helping bring new treatments to rare disease patients
ASSUMPTION: This role requires a strong understanding of the drug development process, from early clinical trials through to post-marketing surveillance, and the ability to work effectively with various teams and stakeholders.
📋 Key Responsibilities
✅ Authoring clinical documents, including protocols, amendments, and briefing documents
✅ Preparing regulatory and clinical documents such as IND annual reports/DSURs, Investigator’s Brochures, informed consent forms, and clinical study reports (CSRs), ensuring compliance with GCP, ICH, and other regulatory guidelines
✅ Collate, review and interpret clinical data (adverse events, efficacy, PK/PD)
✅ Supporting development of study planning, including SAPs and safety management plan
✅ Collaborating with the project team to evaluate clinical data and contribute to the design of clinical development strategies and study concepts
✅ Co-author company materials, including press releases, website content and social media
✅ Supporting internal reviews for scientific journal submissions and shaping the publication strategy
✅ Writing abstracts, presentations, manuscripts, and grant applications to support scientific and business objectives
✅ Enhance internal workflows by contributing to the development of best practices, Standard Operating Procedures (SOPs), and document templates
✅ Coordinate document reviews, managing multiple deliverables across various stages of development
✅ Prepare submission materials for various stakeholders, including health authorities, review boards, and ethics committees
ASSUMPTION: This role requires strong attention to detail, excellent written communication skills, and the ability to manage multiple projects and deadlines.
🎯 Required Qualifications
Education: Bachelor's degree in life sciences, pharmacy, healthcare, or a related discipline
Experience: Medical writing or clinical science experience within a clinical research setting, with a focus on oncology or rare diseases preferred
Required Skills:
- Proven ability to write a range of clinical trial documents, including protocols, informed consent forms, regulatory submissions (IND sections, CSRs, Investigator’s Brochures) and scientific publications/presentations
- Strong written communication skills
- Ability to work effectively with cross-functional teams
- Knowledge of GCP, ICH, and other regulatory guidelines
Preferred Skills:
- A PhD in life sciences, pharmacy, or a related field
- Strong written communication skills outside of the clinical realm
ASSUMPTION: Candidates with relevant experience in medical writing, clinical research, or a related field, along with a strong academic background, are well-suited for this role.
💰 Compensation & Benefits
Salary Range: CAD 70,000 - 100,000 per year (Estimated based on industry standards for a Medical Writer with 2-5 years of experience in the Biotechnology Research industry in Cambridge, Ontario)
Benefits:
- Competitive salary
- Share options
- 7% employer pension contributions
- Life insurance (4x base salary)
- Private medical insurance
- 25 days annual leave (plus bank holidays) with the option to purchase additional days
- Wellbeing support via Spill and Employee Assistance Programme
- Flexible and remote working options, home office set-up allowance, periodic in-person team days
- Enhanced family leave policies
- Personal learning and development budgets
- One paid day off per year to volunteer for a cause aligned with the company's mission
Working Hours: Full-time (40 hours per week) with flexible remote work options
ASSUMPTION: The salary range provided is an estimate based on industry standards and may vary depending on the candidate's experience and qualifications.
📌 Applicant Insights
🔍 Company Context
Industry: Biotechnology Research
Company Size: 51-200 employees (Mid-sized company offering a collaborative and dynamic work environment)
Founded: 2014 (Established company with a proven track record in rare disease drug discovery and development)
Company Description:
- Healx is a mission-driven technology company pioneering the next generation of drug discovery to bring novel, effective treatments to rare disease patients around the world
- The company combines frontier AI technology with deep drug discovery and development expertise to accelerate the pace, increase the scale, and improve the chance of success of rare disease treatment development
- Healx is committed to caring for rare disease patients, growing as individuals, winning as a team, innovating and delivering on its mission
Company Specialties:
- AI-powered drug discovery
- Rare disease treatment development
- Collaborative and patient-inspired approach to drug development
Company Website: http://www.healx.ai
ASSUMPTION: Healx is a well-established company in the biotechnology research industry, with a strong focus on rare disease drug discovery and development. The company's mission-driven approach and commitment to caring for rare disease patients make it an attractive employer for candidates passionate about making a difference in the lives of patients.
📊 Role Analysis
Career Level: Mid-level (Requires 2-5 years of experience in medical writing or a related field)
Reporting Structure: This role reports to the Clinical Team and works closely with cross-functional teams, including clinicians, scientists, and regulatory affairs professionals
Work Arrangement: Hybrid (Office-based with flexible remote work options, periodic in-person team days for collaboration and celebration)
Growth Opportunities:
- Advancement to Senior Medical Writer or similar roles within the Clinical Team
- Expansion of responsibilities to include mentoring and team leadership
- Potential opportunities to work on high-profile projects and collaborate with external stakeholders
ASSUMPTION: This role offers significant growth opportunities for candidates looking to advance their careers in medical writing and clinical research within the biotechnology research industry.
🌍 Location & Work Environment
Office Type: Hybrid (Office-based with flexible remote work options)
Office Location(s): 66-68 Hills Rd, Charter House, Cambridge, Cambridgeshire CB21LA, GB
Geographic Context:
- Cambridge, Ontario is a vibrant and growing city with a strong biotechnology industry
- The office is located in a modern, collaborative workspace with easy access to public transportation and amenities
- The city offers a high quality of life, with a range of cultural, recreational, and educational opportunities
Work Schedule: Full-time (40 hours per week) with flexible remote work options, periodic in-person team days for collaboration and celebration
ASSUMPTION: The hybrid work environment at Healx offers candidates the best of both worlds, with the opportunity to collaborate and learn from colleagues in an office setting, while also enjoying the flexibility and convenience of remote work.
💼 Interview & Application Insights
Typical Process:
- Online application submission
- Phone or video screening with the HR team
- Technical writing assessment
- In-depth interviews with the Clinical Team and other stakeholders
- Final interview with the hiring manager
Key Assessment Areas:
- Writing and communication skills
- Knowledge of GCP, ICH, and other regulatory guidelines
- Ability to work effectively with cross-functional teams
- Understanding of the drug development process
Application Tips:
- Tailor your resume and cover letter to highlight your relevant medical writing and clinical research experience
- Include examples of your previous work, such as regulatory submissions, clinical study reports, or scientific publications
- Prepare for the technical writing assessment by reviewing the job description and researching the company's mission and values
ATS Keywords: Medical Writing, Clinical Research, Regulatory Submissions, Drug Discovery, Rare Diseases, Biotechnology Research, GCP, ICH, Cross-functional Teams
ASSUMPTION: The application process for this role is competitive, and candidates should be prepared to demonstrate their strong writing and communication skills, as well as their relevant experience and knowledge of the drug development process.
🛠️ Tools & Technologies
- Slack
- GSuite
- Google Meet
- Confluence
- Zoom
- BambooHR
- Xero
- ApprovalMax
- Dext
- Culture Amp
ASSUMPTION: Candidates should be comfortable using a range of collaboration and productivity tools, as well as industry-specific software and platforms.
👔 Cultural Fit Considerations
Company Values:
- Care for Rare - Rare disease patients are at the heart of what we do
- Grow as individuals - We are learners always seeking to enhance our expertise
- Win as a team - We strive to remain inclusive and diverse and we celebrate successes and lessons together
- Innovate and deliver - Our mission requires rapid innovation and calculated risks that won’t compromise our high standards
Work Style:
- Collaborative and dynamic
- Patient-inspired and mission-driven
- Focused on innovation and delivery
Self-Assessment Questions:
- How do you demonstrate care for rare disease patients in your work?
- What steps have you taken to grow as an individual in your previous roles?
- How do you contribute to a collaborative and inclusive team environment?
ASSUMPTION: Candidates should be able to demonstrate a strong fit with Healx's values and work style, with a clear commitment to the company's mission and a passion for making a difference in the lives of rare disease patients.
⚠️ Potential Challenges
- Managing multiple projects and deadlines simultaneously
- Working effectively with cross-functional teams, including clinicians, scientists, and regulatory affairs professionals
- Keeping up-to-date with regulatory guidelines and industry trends
- Adapting to a dynamic and fast-paced work environment
ASSUMPTION: These challenges require strong organizational skills, excellent communication and collaboration abilities, and a proactive approach to continuous learning and development.
📈 Similar Roles Comparison
- Medical Writer vs. Senior Medical Writer: The Medical Writer role focuses on authoring clinical documents and regulatory submissions, while the Senior Medical Writer role involves additional responsibilities such as mentoring, team leadership, and strategic decision-making
- Biotechnology Research vs. Pharmaceutical Industry: The biotechnology research industry is more dynamic and fast-paced, with a greater emphasis on innovation and collaboration, while the pharmaceutical industry is more established and focused on large-scale production and distribution
- Clinical Research vs. Medical Affairs: The Medical Writer role is focused on regulatory submissions and clinical trial documentation, while the Medical Affairs role involves external communications, stakeholder engagement, and market access strategies
ASSUMPTION: Candidates should consider their career goals, work preferences, and industry-specific context when comparing similar roles and making decisions about their next career move.
📝 Sample Projects
- Developing a comprehensive regulatory submission package for a Phase III clinical trial in a rare disease indication
- Collaborating with a cross-functional team to design and implement a patient-centric clinical trial protocol for a rare disease population
- Writing and submitting a successful grant application to fund a cutting-edge rare disease research project
ASSUMPTION: These sample projects demonstrate the range of responsibilities and required skills for the Medical Writer role at Healx, with a focus on regulatory submissions, clinical trial documentation, and patient-centric approaches to drug discovery and development.
❓ Key Questions to Ask During Interview
- What are the most pressing challenges facing the Medical Writer team currently, and how can this role contribute to addressing them?
- How does Healx support the professional development and growth of its Medical Writer team members?
- What is the company's approach to work-life balance and employee well-being, particularly for remote and hybrid workers?
- How does Healx engage with and learn from rare disease patient communities to inform its drug discovery and development efforts?
- What opportunities are there for collaboration and knowledge-sharing with other teams and departments within the company?
ASSUMPTION: These questions demonstrate a candidate's interest in the role, the company, and its mission, as well as their commitment to professional growth and development.
📌 Next Steps for Applicants
To apply for this position:
- Submit your application through this link
- Tailor your resume and cover letter to highlight your relevant medical writing and clinical research experience, as well as your alignment with Healx's values and mission
- Prepare for the technical writing assessment by reviewing the job description and researching the company's mission and values
- If selected for an in-depth interview, be prepared to discuss your relevant experience and provide examples of your previous work
- Follow up with the HR team within one week of your interview to express your appreciation for the opportunity and reiterate your interest in the role
⚠️ This job description contains AI-assisted information. Details should be verified directly with the employer before making decisions.
