Associate Director Medical Writing Asset Lead Oncology

6-14 years

Not Disclosed

Bangalore India

10 Feb. 13, 2025

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

Location: Bengaluru, India
Site: Bengaluru Luxor North Tower
Posted Date: Feb 6, 2025
Job ID: 414477
Years of Experience: 6-14 years

About the Position:

As an Associate Director Medical Writing Asset Lead, you will play a pivotal role in shaping operational strategy and accelerating product approvals, particularly in clinical pharmacology. This highly visible role involves implementing the medical writing strategy across one or more therapeutic area assets, delivering high-quality, fit-for-purpose clinical documents, and contributing to organizational process improvements.

Key Responsibilities:

Leadership and Expertise:

Medical Writing Lead for one or more medicines/vaccine assets throughout the lifecycle of drug development, focusing on clinical pharmacology.
Provide medical writing strategy for the development of clinical programs and document content.
Lead the matrix team to deliver high-quality clinical documents such as clinical study protocols, clinical study reports, briefing documents, Common Technical Document (CTD) Summaries, and more.
Collaborate with in-house CROs and independent contractors to ensure the on-time delivery of high-quality documents.
Collaborate closely with Global Regulatory Affairs and other cross-functional groups to understand business needs and clinical data.
Drive high-performance standards and encourage similar standards across the matrix team.
Ensure Medical Writing strategy is aligned with portfolio strategy, prioritization, and accelerated timelines.

Matrix Teamwork and Function:

Establish quality, efficiency, and effective teamwork across all clinical document teams.
Contribute significantly to complex clinical submission documents and document strategy.
Foster collaboration with stakeholders to ensure the efficient delivery of documents.
Provide resourcing information to the Medical Writing Therapeutic Area Head to ensure optimal resource utilization.

Relationship, Influence, and Communication:

Lead and influence teams within a matrix environment.
Build and maintain networks at various levels (project, departmental, inter-departmental).
Ensure timely dissemination of information to maintain transparency and shared learnings.
Advocate for medical writers, team members, and senior stakeholders to effectively contribute to document development.
Encourage open and honest communication, decision-making, and risk-taking within the team and across cross-functional platforms.

Planning, Organization, and Team Coordination:

Develop and implement study and document resourcing strategies to meet project objectives and deliverables.
Plan and adjust strategies to ensure the efficient delivery of documents, even when project timings change.

Process Improvement and Compliance:

Engage in process improvement and training initiatives to enhance document quality and compliance.
Identify risks to strategic, ethical, or compliance objectives and implement mitigation strategies.
Ensure quality writing practices and effective communication within study teams.

Additional Responsibilities:

Monitor efficiency, quality, and scientific integrity of writing.
Drive submission planning and delivery through agile and efficient processes.
Manage resource allocation to optimize delivery timelines.

Basic Qualifications:

PhD, PharmD, MPH, MSc, or other post-graduate degree.
6+ years of experience in clinical pharmacology and clinical regulatory writing in the pharmaceutical industry.
Proven track record in writing clinical documents (e.g., CTD, CSR, protocols, etc.).
6+ years of experience in project management, planning, communication, and matrix leadership.
Familiarity with International Council for Harmonization (ICH) and Good Clinical Practice (GCP) Guidelines.

Preferred Qualifications:

Experience in modeling and simulation, immunogenicity, biomarkers, and virology.
Highly effective communication skills and the ability to present complex ideas to senior stakeholders.
Proven ability in creative problem resolution and quality decision-making.
Experience analyzing scientific and operational information and implementing effective solutions.
Experience in Risk Management and Management Monitoring.
Demonstrated ability to prioritize tasks and meet deadlines in a dynamic environment.

Inclusion & Diversity at GSK:

At GSK, we are committed to fostering an inclusive and diverse work environment. We value the unique perspectives and experiences of our employees and strive to create an atmosphere where everyone feels welcome, valued, and respected.

Why GSK?

GSK is a global biopharma company united by a shared purpose – to get ahead of disease together, improving the health of billions of people worldwide.
We focus on vaccines, specialty, and general medicines, with a particular emphasis on oncology, infectious diseases, respiratory, and HIV.
We are committed to creating an environment where people can thrive and contribute to the success of our organization.

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