Principal Medical Writer

2+ years

Not Disclosed

Bangalore

10 Dec. 19, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Principal Medical Writer
Location: Bengaluru Luxor North Tower, Bangalore
Posted Date: Dec 17, 2024
Experience: 10 - 12 years

About GSK:
GSK is a global biopharma company with a mission to unite science, technology, and talent to get ahead of disease together. By focusing on therapeutic areas such as infectious diseases, HIV, respiratory/immunology, and oncology, we strive to positively impact global health and deliver sustainable shareholder returns. We believe in creating an environment where people can thrive, grow, and feel supported.

Role Overview:
As a Principal Medical Writer, you will serve as an expert contributor, executing complex writing assignments related to clinical trial designs and interpreting statistically analyzed research data. This role requires a deep understanding of clinical regulatory documents and the ability to draft, review, and approve written submissions for marketing applications. You will play a key role in driving the writing process, collaborating with cross-functional teams to ensure the creation of high-quality documents that align with GSK standards and regulatory requirements.

Key Responsibilities:

Write clinical regulatory documents such as protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
Collaborate in matrix teams to produce high-quality clinical documents that reflect the associated data accurately and meet global, regional, and local regulatory standards.
Contribute significantly to the planning and production of clinical dossier documents for global regulatory submissions.
Manage increasingly complex projects and develop effective plans for solutions.
Demonstrate a high level of technical, statistical, and computer skills to interpret complex clinical data.
Assess trends and patterns in text and statistical data, organizing content and messages in clinical reports and summary documents.
Provide input on reporting and analysis plans, ensuring accurate content and effective presentation of data.
Familiarity with automation and tools to expedite document preparation.
Adjust priorities and behaviors to meet changing demands and therapeutic areas.
Communicate effectively both orally and in writing, ensuring clarity and precision in all deliverables.

Qualifications & Experience:

Education: PhD or relevant working experience in life sciences.
Job-Related Experience:
- Experience in clinical regulatory writing within the pharmaceutical industry.
- Demonstrated leadership and ability to manage cross-functional teams.
- Familiarity with ICH/Good Clinical Practice (GCP) guidelines.
- Experience working in multicultural settings and with remote teams.
- Ability to interpret and document clinical data.
- Strong English language skills (verbal and written).

Why GSK?
At GSK, we offer a dynamic, inclusive environment where our people thrive. With a focus on delivering high-quality results and making an impact, we encourage continuous learning, collaboration, and personal growth. If you’re driven to innovate and positively influence healthcare, join us at this exciting time as we work together to get ahead of disease.

Important Notice:
GSK does not accept referrals from employment businesses/agencies. Any unauthorized referrals will not be liable for fees. Please be aware of fraudulent job ads or emails requesting payments for recruitment. GSK does not charge any fee for recruitment processes.

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Principal Medical Writer

Job Description

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