Novartis · 14 hours ago

Senior Scientific/Regulatory Writer

Remote Position (USA)

Full-time

Remote

Mid, Senior Level

$124K/yr - $186K/yr

2+ years exp

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Responsibilities

To author and review high quality clinical and safety documents: non-registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Risk Management Plans (RMP).

Lead for outsourced Narrative projects. Coordinate other outsourced activities in RWS.

Core member of Clinical Trial Team (CTT) / participate in Safety Management Team(SMT).

Actively participate in planning of data analyses and presentation used in CSRs.

Act as documentation consultant in CTTs and SMTs to ensure compliance of documentation to internal company standards and external regulatory guidelines.

May act as Program Writer ensuring adequate medical writing resources are available for assigned program and consistency between documents.

Act as liaison between CTTs and publishing teams to ensure timely delivery of final documents for publishing.

Support the development of RWS through participating in RWS workstreams and other related activities.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Medical WritingRegulatory ComplianceClinical ResearchClinical TrialsGlobal Regulatory Knowledge

Required

Minimum university life science degree or equivalent is required.

≥ 2 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus strong knowledge of the medical writing processes.

Good knowledge of and some experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements).

Knowledge of process for and some experience in global registering of drugs (simple submissions).

Excellent communication skills (written, verbal, presentations).