Job Title: Senior Medical Writer 1
Job ID: REQ-10037403
Location: Hyderabad, India
Company: Novartis Healthcare Private Limited
About the Role:
The Senior Medical Writer 2 will be responsible for writing, reviewing, and managing the preparation of high-quality clinical documents for Clinical and Pharmaceutical Operations (CPOs) and the global organization. The role involves providing expert documentation-related consultancy to other line functions.
Key Responsibilities:
Document Preparation:
Author, review, and manage clinical documents such as Clinical Study Reports (CSRs), Protocols, Informed Consent Forms (ICFs), CTD modules, and safety documents (e.g., DSURs, RMPs).
Liaise with medical/clinical experts, statisticians, and investigators during concept development and protocol creation.
Contribute to planning data analyses and presentations for CSRs.
Compliance & Quality:
Ensure documentation compliance with internal company standards and external regulatory guidelines.
Act as a project medical writer for various programs and ensure proper resource allocation.
Supervise external medical writers if required and mentor other writers in the team.
Collaboration & Communication:
Support cross-functional communication to optimize feedback and produce high-quality documents.
Track clinical trial milestones and resource needs for assigned projects.
Training & Mentoring:
Provide training and mentorship to junior associates and new medical writers.
Essential Requirements:
Education:
Minimum: University degree in life sciences (or equivalent).
Advanced degree (e.g., PhD, MD, or Master's in life sciences/medicine/pharmacy) is desirable.
Experience:
At least 4 years of regulatory medical writing experience or similar pharma industry experience.
Strong knowledge of clinical trial reporting and biostatistics principles.
Familiarity with global regulatory environments, approval processes, safety reporting requirements, and submission documents.
Skills:
Excellent communication (written, verbal, presentations) skills.
Ability to manage multiple projects and prioritize effectively.
Strong customer-oriented mindset.
Desirable Requirements:
Demonstrated ability to work in a matrix and multicultural environment.
Experience managing global, cross-functional teams or simple global projects.
Why Novartis?
Innovative Science: Join Novartis to be part of a team committed to breakthroughs that improve and extend people's lives.
Diversity & Inclusion: Novartis values creating an inclusive and diverse work environment where everyone can contribute to achieving company goals.
Benefits & Rewards: Explore comprehensive benefits and career growth opportunities through the Novartis Life Handbook.
How to Apply
To apply for this position, visit the Novartis Career Portal.
Additional Information
Accessibility: If you need a reasonable accommodation due to a medical condition or disability, contact diversityandincl.india@novartis.com.
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