Senior Medical Writer

GSK•Mississauga, ON

2d•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 organizations.

Requirements

Up to 5 years clinical regulatory writing experience in the pharmaceutical industry.
At least 4 years of clinical or safety medical writing experience in the pharmaceutical industry.
Proven experience preparing clinical or safety documents (for example, clinical study reports).
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

Experience with aggregate safety reports and pharmacovigilance documents (for example, DSUR, PBRER, PADER).
Experience authoring regulatory submission modules and clinical overviews.
Advanced degree such as PhD, PharmD or MD, or equivalent experience.
Working knowledge of international regulatory guidance (for example, ICH, GCP, GVP).
Proven ability to lead small projects and deliver multiple documents simultaneously.
Experience mentoring junior writers and improving medical writing processes.

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.