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Medical Writer

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GSK

3d ago

  • Job
    Full-time
    Mid Level
  • Research & Development
    Healthcare
  • Mississauga

AI generated summary

  • You should have a PhD, up to 3 years in clinical regulatory writing, knowledge of drug development, ICH/GCP, and excellent English skills.
  • You will author and review clinical documents, ensure data integrity and quality, participate in meetings, manage multiple assignments, and collaborate with diverse teams to maintain writing standards.

Requirements

  • PhD or equivalent expertise
  • Up to 3 years clinical regulatory writing experience in the pharmaceutical industry
  • 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)

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.

FAQs

What is the primary responsibility of a Medical Writer at GSK?

The primary responsibility of a Medical Writer at GSK is to independently author and coordinate the development of a range of clinical documents while ensuring high integrity, consistency, and quality in the writing assignments.

What kind of documents will a Medical Writer be expected to create?

A Medical Writer will be expected to create various clinical documents, including regulatory documents such as protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.

What educational background is required for this position?

A PhD or equivalent expertise is required for the Medical Writer position.

How many years of experience in clinical regulatory writing are preferred for this role?

Up to 3 years of clinical regulatory writing experience in the pharmaceutical industry is preferred for this role.

What are the essential skills required for a Medical Writer at GSK?

Essential skills include a good understanding of drug development, knowledge of scientific methodology and statistical principles, understanding of how to interpret and document clinical data, familiarity with ICH/GCP guidelines, and excellent English language skills (verbal and written).

Will a Medical Writer work independently or as part of a team?

A Medical Writer will work largely independently or on complex documents under the guidance of a mentor while collaborating with various stakeholders at different levels within GSK.

What kind of environments will a Medical Writer need to navigate?

A Medical Writer will need to navigate complex matrix organizations, establishing communication networks and building collaborations to facilitate smooth partnerships in delivering writing assignments.

What is the company’s commitment regarding diversity and inclusion?

GSK is committed to diversity and inclusion, welcoming applications from all qualified individuals and accommodating persons with disabilities throughout the application process.

How does GSK support employee wellbeing and growth?

GSK strives to create an inspiring environment where employees feel welcome, valued, and included, offering opportunities for personal and professional growth and support for wellbeing.

What should candidates do if they require accommodation during the application process?

Candidates requiring accommodation at any stage of the application process should contact GSK at canada-recruitment@gsk.com for more information on accommodation policies.

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

GSK, or GlaxoSmithKline, is a company that operates in the pharmaceutical and healthcare industry. They are involved in researching, developing, manufacturing, and selling a wide range of prescription medicines, vaccines, and consumer healthcare products. GSK's ultimate aim is to improve the quality of human life by providing innovative and effective healthcare solutions to people worldwide. Their commitment lies in focusing on scientific excellence, developing cutting-edge medicines and vaccines, and addressing global health challenges to help people live longer, healthier lives.

Benefits

  • A competitive base salary

  • An annual bonus based on company performance

  • Access to healthcare and wellbeing programmes, pension plan membership, savings programmes, time off and childcare support

  • Employee recognition programmes that reward exceptional achievements