Senior Medical Writer
About the Role
Company Overview
GSK is one of the leading companies which are involved in biopharmaceuticals on an international level. GSK’s objective is to bring new medicines and vaccines into the lives of people around the world and try to make their lives better. GSK is able to meet the medical requirements of patients worldwide through science and technology and skilled people from all over the world.
Job Overview
The Senior Medical Writer is integral to the development and dissemination of high-quality documents in the process of developing drugs. The job will entail independent execution of writing tasks together with collaboration with cross-functional groups to ensure that the documents are completed and delivered on time.
The position requires a good knowledge base on how clinical trials should be designed and interpreted. It is the responsibility of the senior medical writer to coordinate the development of these documents, right from the conceptual stage to completion, in accordance with international quality standards.
Key Responsibilities
Develop, write, and finalize a variety of clinical and regulatory documents based on the global templates and guidance documents.
Prepare important documents like clinical study protocol, clinical study report (CSR), Investigator brochure, and regulatory submission dossier (like CTD modules).
Respond to the questions raised by regulatory agencies and work on the documentation of the submissions.
Provide accuracy, clarity, and scientific credibility in all the documents written with proper interpretation of the clinical and statistical data.
Perform several writing tasks simultaneously, meeting timelines and standards.
Work with multi-disciplinary teams like clinical leads, statisticians, regulatory professionals, and other writers.
Be actively involved in the document planning process, review, and discussions to achieve coordination among all the parties involved.
Find problems with data analysis and documentation organization and offer appropriate solutions.
Guarantee consistency, adherence, and quality of all deliverables according to the internal standards and regulatory requirements.
Establish good relationships between all teams for successful cooperation and communication.
Qualifications and Experience
Bachelor’s or advanced degree in:
Life sciences
Pharmacy
Medicine, or
Related discipline
3-5 years of work experience in medical or regulatory writing in the field of pharmaceuticals, biotechnology, or Contract Research Organization.
Knowledge about the drug development process and clinical trial and submission requirements.
Capacity to understand and convert clinical data and scientific information into well-organized documents.
Awareness about ICH and GCP guidelines.
Skills and Competencies
Possession of excellent writing and oral communication abilities in English with great attention to detail.
Excellent analytical capabilities with the ability to synthesize information gathered from various sources.
Good project management and organizational abilities with capacity for multitasking.
Capacity to perform tasks individually and collaboratively as part of a team.
Proficiency in the use of normal document management software and computer applications.
Highly responsible and professional.
Salary, Career Growth and Benefits
The salary for this position is 10-12 LPA. In addition to competitive compensation packages, there are also wellness activities for its employees.
GSK creates a workplace that is encouraging and open to all its employees. Employees benefit from an environment of constant learning and development. Workers get an insight into global healthcare projects and scientific innovations. There is potential for career advancement with training. You'll also get to work on groundbreaking developments in healthcare.
Role Importance
The Senior Medical Writer plays an important part in the successful completion of clinical and regulatory processes. The job entails ensuring that all the documentation provided is both accurate and compliant with all relevant regulations. The role helps in the advancement of new treatments by facilitating the process of bringing new therapies to market.
How To Apply
If this is the position you seek to apply for, you should apply through the following procedure:
Create your account in Jobslly.
Search for the position Senior Medical Writer / GSK.
Upload your updated resume.
Upload all the related certificates.
Complete the application form.
Ensure your resume highlights relevant education, attention to detail, and any experience in medical writing.
Market Insights & Trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.