Senior Medical Writer

GSK•Mississauga, ON

22d•CA$103,000 - CA$153,000•Hybrid

About The Position

The Senior Medical Writer is expected to work on assignments largely independently or for complex documents, under guidance of a mentor, facilitating delivery of the written assignments through proactive coordination of stakeholders to build content. The senior medical writer understands clinical trials design and interpretation of statistically analysed clinical research data. He/she would be expected to drive and coordinate the process to draft, review and approve written assignments and should be able to meet the quality standards of the global organization. The Senior Medical Writer is responsible for the final deliverable and is expected to work in complex matrix organization.

Requirements

Possesses a good understanding of basic drug development
Demonstrates knowledge of scientific methodology and statistical principles in the design, conduct and description of clinical research.
Demonstrates understanding of how to interpret, describe and document clinical data.
Possesses working knowledge of International Committee for Harmonisation (ICH) / Good Clinical Practice (GCP).
Possesses necessary computer skills and general computer literacy.
Excellent English language skills (verbal and written)

Nice To Haves

PhD or equivalent expertise (e.g., a master’s degree with a minimum of 2 years’ relevant experience)
8 years clinical regulatory writing experience in the pharmaceutical industry
Clinical Study Reports
Clinical Trial Protocols
Investigator's Brochure (IB)
Medical Writing
Scientific Writing

Responsibilities

Completes assignments independently or for more complex documents, under guidance of a mentor
Authors a range of clinical documents, including regulatory documents following defined templates, including but not limited to protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
Ensures high integrity of data interpretation, following negotiation with document team.
Ensures the consistency and quality level of all documents that are issued.
Actively participates in all planning, coordination and review meetings.
Ability to work on 2-3 assignments simultaneously.
Proactively raises and discusses concerns/ issues in an open and timely manner and within the global team, thereby demonstrating the ability of promoting high medical writing standards by pointing out obvious flaws and proposing (and advocating) alternatives.
Works directly with a diversity of roles at different levels within GSK (e.g., Clinical Leads, Asset Leads, Study Delivery Leads (SDL), Biostatisticians, other Medical Writers).
Establishes network of communication and continuously builds collaboration to facilitate smooth partnerships and interfaces between all groups involved in delivery of writing assignments.

Benefits

GSK is dedicated to promoting transparency and fairness throughout our recruitment process.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together.
We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive.
We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines.
We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most.
Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.
Please contact our Recruitment Team at [email protected] to discuss your needs.