Senior Scientific Writer
- Bangalore, India
Site Name: India - Karnataka - Bengaluru
Posted Date: Sep 26 2019
- Contributes to documents and activities to be included in registration files.
- Authors clinical documents following defined templates.
- 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 Vaccines, thereby demonstrating the ability of promoting high scientific standards by pointing out obvious flaws and proposing (and advocates) alternatives.
- Works directly with diversity of roles at different levels within GSK (e.g., Clinical Research and Development Leader (CRDL), Project Level CRDL, Regional Medical Directors and Advisors, Study Delivery Leads (SDL), Study Data Managers (SDM), Biostatisticians, other Scientific Writers).
- Establishes network of communication and continuously builds collaboration to facilitate smooth partnerships and interfaces between all groups involved in delivery of writing assignments.
- Preferable 2 - 5 years regulatory writing experience in the pharmaceutical industry or medical field is an asset.
- Educational qualifications: PHD/Masters degree or above)
- Possesses a good understanding of basic immunology and area of assigned vaccine project.
- Demonstrates knowledge of scientific methodology in the design, conduct and description of clinical research.
- Demonstrates understanding of how to analyse and describe clinical results.
- Understands the organization of clinical study reports and scientific presentations.
- 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 command over English language (verbal and written)
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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 GlaxoSmithKilne (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 email@example.com, so that we can confirm to you if the job is genuine.
Back to top