Senior Medical Writer
Senior Medical Writer
Posted on :
05-02-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Job Title: Senior Medical Writer
Job Location: Bengaluru Karnataka India
Job Location Type: Onsite
Job Contract Type: Fulltime
Job Seniority Level:
Site Name: Bengaluru Luxor North Tower
Posted Date: Jan 30 2025
Years of Experience: 6 9 years
Skill Set / Exposure: Clinical and Regulatory document writing CSR Briefing Document Module (m2.5 m2.7.1 & m2.7.2).
Work Location: Bengaluru
Job Purpose:
At GSK we are dedicated to fostering an inclusive and diverse work environment. We believe that diversity in our workforce drives innovation and growth and we are committed to providing equal opportunities for all employees and applicants. We strive to create an atmosphere where all individual’s unique perspectives and experiences are valued and respected. All qualified applicants will receive equal consideration for employment without regard to their sex or gender caste pregnancy gender identity/expression physical and/or mental disability or any other protected characteristic as per applicable law.
As an employer committed to Diversity and Inclusion we encourage you to reach out if you need any adjustments during the recruitment process.
Please contact our Recruitment Team at to discuss your needs.
Why GSK
Uniting science technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies investing in four core therapeutic areas (infectious diseases HIV respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome valued and included. Where they can keep growing and look after their wellbeing. So if you share our ambition join us at this exciting moment in our journey to get Ahead Together.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way.
GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable.
If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com” you should disregard the same and inform us by emailing so that we can confirm to you if the job is genuine.
Posted Date: Jan 30 2025
Years of Experience: 6 9 years
Skill Set / Exposure: Clinical and Regulatory document writing CSR Briefing Document Module (m2.5 m2.7.1 & m2.7.2).
Work Location: Bengaluru
Job Purpose:
- 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 analyzed 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.
- 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 23 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.
- PhD or equivalent expertise (e.g. a master’s degree with a minimum of 2 years’ relevant experience)
- Job Related Experience
- Up to 5 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)
At GSK we are dedicated to fostering an inclusive and diverse work environment. We believe that diversity in our workforce drives innovation and growth and we are committed to providing equal opportunities for all employees and applicants. We strive to create an atmosphere where all individual’s unique perspectives and experiences are valued and respected. All qualified applicants will receive equal consideration for employment without regard to their sex or gender caste pregnancy gender identity/expression physical and/or mental disability or any other protected characteristic as per applicable law.
As an employer committed to Diversity and Inclusion we encourage you to reach out if you need any adjustments during the recruitment process.
Please contact our Recruitment Team at to discuss your needs.
Why GSK
Uniting science technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies investing in four core therapeutic areas (infectious diseases HIV respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome valued and included. Where they can keep growing and look after their wellbeing. So if you share our ambition join us at this exciting moment in our journey to get Ahead Together.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way.
GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable.
If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com” you should disregard the same and inform us by emailing so that we can confirm to you if the job is genuine.
/jobs/view/b10e80ea890db6c5fd40c54a92bc329e
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
