Job Description

Years of Experience: 10-15 years
Skill Set / Exposure: Clinical and Regulatory document writing, Protocol, ICF and Modules (m2 & m5).
Work Location: Bengaluru (Hybrid Mode)
:

• The Medical Writing Manager is an individual expert contributor capable of independently executing complex writing assignments involving a thorough understanding of clinical trials designs and interpretation of statistically analyzed research data.
• He/she would be expected to drive and coordinate the process to draft, review and approve written assignments including marketing application submission documents.
• This role has extensive clinical document expertise and will lead in the implementation of best practices and continuous improvement.
• He/she has the ability to plan and prioritize without supervision.

Key Responsibilities:

• Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role.
• Proven track record in writing 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.
• Work in a matrix team to ensure delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data, and are in line with GSK standards and global, regional and/or local regulatory requirements.
• Experienced as a significant contributor in planning and production of clinical dossier documents for regulatory submissions worldwide.
• Demonstrated effectiveness in management of projects of increasing scope and complexity.
• Understanding of the interdependencies of various contributing functions (e.g., clinical pharmacology, biomarkers, health outcome).
• Ability to quickly assess complex situations, apply scientific, operational, and submission development knowledge and implement effective plans for solutions.
• High-level technical, statistical, and computer skills, and the ability to interpret complex clinical data.
• Assess trends and patterns in text and statistical data, and effectively organizes content and messages in clinical reports and summary documents.
• Review reporting and analysis plans and provides critical input on the content and display of tables.
• Familiarity with approaches to expedite document preparation such as review tools and automation.
• Can mentor junior writers.
• Demonstrated ability and willingness to adjust behaviors and priorities based on a changing environment (e.g., ability to support documents in different therapeutic areas).
• Effectiveness in both oral and written communications.

Knowledge/Education Required:

• PhD or equivalent expertise (e.g., a masters degree with relevant experience)
• The role will require a good understanding of complex regulatory writing processes including data interpretation & skills to communicate information to target audiences.
• The post graduate qualification should reflect experience of independently conducting scientific research, data interpretation and ability to write for a scientific audience.

Experience Required:

• Preferably at least 5 years relevant clinical regulatory writing experience in the pharmaceutical industry.

List below any licenses, certificates, registrations, or any relevant job skill or abilities not covered in Educational Background or Job-Related Experience sections above that are required for the job:

• Possesses a good understanding of drug development.
• Demonstrates knowledge of scientific methodology and statistical principles in the design, conduct and description of clinical research.
• Clear demonstration of 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).

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, its 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.
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