Senior Medical Writer

📌 Core Information

🔹 Job Title: Senior Medical Writer

🔹 Company: GSK

🔹 Location: Mississauga, Ontario, Canada

🔹 Job Type: On-site

🔹 Category: ✍️ Copywriting & Content Writing

🔹 Date Posted: March 31, 2025

🔹 Experience Level: 2-5 years

🔹 Remote Status: Hybrid

📌 Essential Job Details

🚀 Job Overview

Key aspects of this role include:

• Working independently on assignments, especially complex documents under mentor guidance.
• Authoring a wide range of clinical documents including regulatory submissions.
• Ensuring data integrity and quality in all documentation.
• Coordinating with multiple stakeholders in a complex matrix organization.

ASSUMPTION: The role entails significant responsibility for document integrity and stakeholder coordination, suggesting that the successful candidate will need excellent communication and organizational skills.

📋 Key Responsibilities

✅ Complete assignments independently or collaboratively under mentorship.

✅ Author clinical documents using defined templates.

✅ Ensure high data integrity and quality assurance.

✅ Participate in planning, coordination, and review meetings.

✅ Manage multiple assignments effectively and propose alternatives to overcome document flaws.

✅ Engage with diverse roles within GSK.

✅ Build communication networks and facilitate smooth partnerships.

ASSUMPTION: Emphasis on communication and relationship-building suggests the role involves significant cross-functional collaboration.

🎯 Required Qualifications

Education: PhD or equivalent expertise (Master’s degree with a minimum of 2 years’ relevant experience).

Experience: Up to 5 years of clinical regulatory writing experience in the pharmaceutical industry.

Required Skills:

• Understanding of drug development.
• Knowledge of scientific methodology and statistical analysis.
• Proficiency in interpreting and documenting clinical data.
• Excellent English communication skills.

Preferred Skills:

• Experience with International Committee for Harmonisation (ICH)/Good Clinical Practice (GCP).
• Strong IT skills.

ASSUMPTION: Given the technical nature of the role, candidates are expected to possess strong analytical skills and familiarity with statistical principles.

💰 Compensation & Benefits

Salary Range: Not specified, but competitive according to industry standards.

Benefits:

• Attractive reward package including annual bonuses and recognition awards.
• Hybrid working model where applicable, with support for work-life balance.
• Comprehensive health benefits and private medical packages.
• Opportunities for personal and professional development.

Working Hours: 40 hours per week, with flexible working solutions.

ASSUMPTION: The benefits package suggests GSK values employee well-being and professional growth.

📌 Applicant Insights

🔍 Company Context

Industry: Pharmaceutical Manufacturing

Company Size: 10,001+ employees, indicating a large-scale operation with resources for extensive projects.

Founded: Not specified

Company Description:

• Leading global healthcare company.
• Focus on uniting science, technology, and talent against diseases.
• Emphasizes sustainable practices and employee growth.

Company Specialties:

• Pharmaceutical products.
• Vaccines.

Company Website: http://www.gsk.com

ASSUMPTION: GSK’s large size and focus on innovation suggest robust support systems and advancement opportunities for employees.

📊 Role Analysis

Career Level: Senior level, indicating substantial responsibility and autonomy.

Reporting Structure: Reports to a mentor with diverse internal coordination.

Work Arrangement: Hybrid, offering flexibility between on-site and remote work.

Growth Opportunities:

• Development within the role and company structure.
• Access to global training platforms.
• Career progression through various development programs.

ASSUMPTION: The hybrid work model and focus on development indicate a forward-thinking work culture.

🌍 Location & Work Environment

Office Type: Modern office with creative spaces and amenities.

Office Location(s): Mississauga, Ontario, Canada

Geographic Context:

• Close to the major urban center of Toronto.
• Located in a developing pharmaceutical hub in Canada.
• Offers a blend of urban and suburban lifestyle options.

Work Schedule: Regular 40-hour workweek with flexible hours.

ASSUMPTION: The strategic location in Mississauga suggests good networking opportunities within the pharma industry.

💼 Interview & Application Insights

Typical Process:

• Online application submission.
• Initial screening by HR.
• Technical interviews focusing on regulatory writing skills.

Key Assessment Areas:

• Technical proficiency in clinical and regulatory writing.
• Problem-solving skills.
• Communication and coordination abilities.

Application Tips:

• Highlight experience in regulatory writing and clinical trials.
• Demonstrate strong analytical and problem-solving skills.
• Emphasize any prior experience in large matrix organizations.

ATS Keywords: Clinical Trials Design, Statistical Analysis, Regulatory Writing, Data Interpretation

ASSUMPTION: The application process likely prioritizes candidates with strong communication and documentation skills.

🛠️ Tools & Technologies

• Document management systems.
• Statistical analysis software.
• Team collaboration tools like Microsoft Teams or Slack.

ASSUMPTION: Familiarity with industry-standard documentation and statistical tools is essential for the role.

👔 Cultural Fit Considerations

Company Values:

• Integrity and transparency.
• Respect for people.
• Innovation with a focus on collaboration.

Work Style:

• Proactive and solution-oriented.
• Teamwork and communication are key.
• Adaptability in a fast-paced environment.

Self-Assessment Questions:

• Do you thrive in a collaborative, dynamic work environment?
• Are you skilled in interpreting and communicating complex data effectively?
• Can you manage multiple deadlines and stakeholders simultaneously?

ASSUMPTION: The cultural emphasis on collaboration and innovation indicates an adaptive and forward-thinking work environment.

⚠️ Potential Challenges

• Managing multiple complex projects simultaneously.
• Ensuring consistency and high standards across all documentation.
• Navigating a matrix organization with diverse roles.
• Adapting to evolving regulatory standards and guidelines.

ASSUMPTION: The role requires excellent organizational and prioritization skills to balance multiple projects effectively.

📈 Similar Roles Comparison

• Senior Technical Writer in Pharmaceuticals – Focuses more on technical manuals and less on clinical data.
• Regulatory Affairs Specialist – Primarily responsible for regulations and compliance, not content creation.
• Clinical Research Scientist – Engages more with data collection and analysis than documentation.

ASSUMPTION: Compared to other similar roles, the Senior Medical Writer focuses heavily on documentation quality and compliance.

📝 Sample Projects

• Developing NDA submission documents for a new drug.
• Creating comprehensive clinical study reports for multi-site trials.
• Authoring briefing documents for regulatory authority meetings.

ASSUMPTION: Projects will likely require close collaboration with multi-disciplinary teams and subject matter experts.

❓ Key Questions to Ask During Interview

• What are the characteristics of successful medical writers at GSK?
• How does GSK support professional development in this role?
• Can you describe a challenging project recently completed by the medical writing team?
• How does GSK ensure the quality and consistency of its regulatory documents?
• What role does the medical writing team play in new drug development at GSK?

ASSUMPTION: These questions help gauge GSK's support for career development and its focus on quality and innovation.

📌 Next Steps for Applicants

To apply for this position:

• Submit your application through this link
• Ensure your resume highlights the outlined key skills.
• Prepare to demonstrate your expertise in regulatory writing during interviews.
• Research GSK's latest products and innovations to discuss in the interview.
• Contact the recruitment team if you require any adjustments during the application process.

⚠️ This job description contains AI-assisted information. Details should be verified directly with the employer before making decisions.