Company Name: GlaxoSmithKline Pharmaceuticals Limited
Designation: Senior Medical Writer
Experience: 2 – 5 years
Job Description: Are you energized by a medical writing role that allows you to leverage your scientific knowledge while driving compliance in support of the business If so, this Scientific and Medical Writing Manager role could be an ideal opportunity to explore.
As a Scientific & Medical Writing Manager, you will ensure the medical accuracy of translations and inclusion mandatory information per global guidance. In addition, you will certify that the material complies with applicable local codes, relevant policies and SOPs, and that final material is appropriate for use with the intended target audience.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Contributes to documents and activities to be included in registration files.
- Authors clinical regulatory documents following defined templates.
- 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 at GSK Pharma, thereby demonstrating the ability of promoting high medical writing standards by pointing out obvious flaws and proposing (and advocating) alternatives.
- Works directly with diversity of roles at different levels within GSK (e.g., Asset Leads, Study Delivery 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.
We are looking for an experience individual and if you have these skills, we would like to speak to you.
- Post-graduate degree in life sciences or equivalent expertise
- Preferable 2 – 5 years clinical regulatory writing experience in the pharmaceutical industry
- Possesses a good understanding of basic drug development.
- Demonstrates knowledge of scientific methodology in the design, conduct and description of clinical research.
- Ability to author clinical regulatory documents following defined templates.
- Demonstrates understanding of how to interpret and describe clinical data.
- Understands the organization of clinical study reports and other documentation.
- Possesses working knowledge of International Committee for Harmonisation (ICH) / Good Clinical Practice (GCP).
- Possesses good working knowledge of statistical principles used in clinical research
- Possesses necessary computer skills and general computer literacy.
- Excellent English language skills (verbal and written)
Salary: Not Disclosed
Website Link: https://gsk.wd5.myworkdayjobs.com/GSKCareers/job/Senior-Medical-Writer_300748