Job Description
Site Name: India - Andra Pradesh - Hyderabad
Posted Date: Nov 2+ 2021
Are you looking for a regulatory Publishing Associate role that will enhance your documentation knowledge and allow you to help shape systems strategy? If so, this could be an exciting opportunity to explore.
These Responsibilities Include Some Of The Following
This role will provide YOU the opportunity to lead key activities to progress YOUR career.
• Responsible for the publishing of centrally supported regulatory dossiers for regulatory affairs category teams, either for direct submission to regulatory authorities, or for submission via local regulatory teams.
• Responsible for the publishing of R&D clinical study reports for the medical operations team.
• Participate in publishing activities and resource management of all assigned submissions/reports/documents in compliance with internal and external publishing quality standards. Works in a collaborative effort with regulatory associates from central function and LOC to ensure assigned submission work is accomplished to agreed timings.
• Prioritize publishing work on dossiers and study reports in order to meet agreed regulatory targets. Work may be self-prioritized or may come from a more senior-level person in the group as part of a larger work plan.
• Develops good working relationships with internal and external customers to facilitate effective communication and to ensure that customers adhere to publishing quality expectations and timelines with respect to the submission assembly and publication process.
• Supports regulatory & medical customers to resolve publishing related issues, with support from senior management as required.
• Provides advice and guidance on the production and publishing of regulatory submissions to R&D project teams, and regulatory affairs directly, to agree approaches and timelines for the supply of submission documents and data for submission preparation.
• Contributes (as per assigned goals) to the evolution of publishing capability, including system enhancements, best-practice process improvements and regulatory intelligence.
Why you?
Preferred Qualifications
If you have the following characteristics, it would be a plus:
• Bachelor’s degree
• 1-4 year of publishing experience of medicinal dossiers in electronic format; preferable in eCTD format
• Excellent verbal and written communications skills
• Ability to work carefully under time constraints and prioritize accordingly
• Adaptable to fast-paced environments with changing circumstances, direction, and strategy
• Exposure to work within a regulated environment, ideally in drug development
Why GSK?
Our values and expectations are at the heart of everything we do and form an important part of our culture.
As GSK Focuses On Our Values And Expectations And a Culture Of Innovation, Performance, And Trust, The Successful Candidate Will Demonstrate The Following Capabilities
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.
• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being.
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness.
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
Posted Date: Nov 2+ 2021
Are you looking for a regulatory Publishing Associate role that will enhance your documentation knowledge and allow you to help shape systems strategy? If so, this could be an exciting opportunity to explore.
These Responsibilities Include Some Of The Following
This role will provide YOU the opportunity to lead key activities to progress YOUR career.
• Responsible for the publishing of centrally supported regulatory dossiers for regulatory affairs category teams, either for direct submission to regulatory authorities, or for submission via local regulatory teams.
• Responsible for the publishing of R&D clinical study reports for the medical operations team.
• Participate in publishing activities and resource management of all assigned submissions/reports/documents in compliance with internal and external publishing quality standards. Works in a collaborative effort with regulatory associates from central function and LOC to ensure assigned submission work is accomplished to agreed timings.
• Prioritize publishing work on dossiers and study reports in order to meet agreed regulatory targets. Work may be self-prioritized or may come from a more senior-level person in the group as part of a larger work plan.
• Develops good working relationships with internal and external customers to facilitate effective communication and to ensure that customers adhere to publishing quality expectations and timelines with respect to the submission assembly and publication process.
• Supports regulatory & medical customers to resolve publishing related issues, with support from senior management as required.
• Provides advice and guidance on the production and publishing of regulatory submissions to R&D project teams, and regulatory affairs directly, to agree approaches and timelines for the supply of submission documents and data for submission preparation.
• Contributes (as per assigned goals) to the evolution of publishing capability, including system enhancements, best-practice process improvements and regulatory intelligence.
Why you?
Preferred Qualifications
If you have the following characteristics, it would be a plus:
• Bachelor’s degree
• 1-4 year of publishing experience of medicinal dossiers in electronic format; preferable in eCTD format
• Excellent verbal and written communications skills
• Ability to work carefully under time constraints and prioritize accordingly
• Adaptable to fast-paced environments with changing circumstances, direction, and strategy
• Exposure to work within a regulated environment, ideally in drug development
Why GSK?
Our values and expectations are at the heart of everything we do and form an important part of our culture.
As GSK Focuses On Our Values And Expectations And a Culture Of Innovation, Performance, And Trust, The Successful Candidate Will Demonstrate The Following Capabilities
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.
• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being.
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness.
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
💡 Quick Summary
Seeking a career-building opportunity? The Regulatory Publishing Associate position is now open for candidates interested in the Remote Jobs sector. This role in Hyderabad offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Remote Jobs is a plus.
