job title: senior medical writer(novartis)

About the Role:

To write, review and manage the preparation of high quality clinical documents for CPO’s and global organization. Provide authoritative documentation related consultancy to other line functions.

Key Responsibilities:

• To author, review and independently manage high quality clinical documents: Clinical Study Reports (CSR) including narratives, Protocol, Informed Consent Form (ICF).

• To write CTD modules and other safety documents (DSURs, RMPs) independently

• Liaise with medical/clinical experts, statisticians, investigators in concept development when protocol is being developed and work in a collaborative fashion for global/CPOs

• Contribute to planning of data analyses and presentation to be used in CSRs

• Ensure compliance of documentation to internal company standards and external regulatory guidelines.

• Supervise outsourcing to external medical writers, if required.

• Training and mentoring of associates as required.

• Contribute to cross-functional communication to optimize feedback and input towards high quality documents. Maintain audit, SOP and training compliance.

Commitment to Diversity & Inclusion: :

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Essential Requirements:

• Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/medicine/pharmacy is desirable.

• 3 years of regulatory medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus in-depth knowledge of medical writing processes.

• Good communication skills (written, verbal, presentations)

• Good operational knowledge of clinical trial reporting.

• Good knowledge of biostatistics principles.

• Strong ability to prioritize and manage multiple demands and projects.

• Knowledge of and experience in global regulatory environment and processes (key regulatory bodies, key documents, approval processes, safety reporting requirements).

• Good experience in managing global, cross-functional teams or simple global projects.

Desirable Requirements:

• Demonstrated ability to establish effective working relationship in a matrix and multicultural environment.

• Demonstrated presentation and diplomacy skills.

• Strong customer-oriented mindset.