Senior Medical Writer – Oncology

Puesto: Senior Medical Writer – Oncology )
As a Principal Medical Writer, you will collaborate with members of cross-functional teams to prepare (or oversee preparation by contract service providers) high-quality protocols, protocol amendments, investigator brochures, synopses, Clinical Study Reports, regulatory documents such as INDs and BLAs, clinical publications, and related clinical documents within agreed-upon timelines.
Key Essential Functions   Prepares, edits, and finalizes protocols, investigator brochures, synopses, Clinical Study Reports, pre-IND, IND, NDA submissions, other regulatory documents and related scientific documents, such as abstracts, posters, presentations, and manuscripts, integrating inputs from other team members into a cogent fit-for-purpose whole.
Participates in scientific communication planning, including development of strategic medical communication plans
Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
Manages all aspects of outsourced or internal deliverable production and ensures project delivery
Partners with other clinical team members including participation in the review of mock and/or blinded tables, figures, and listings (TLFs), and narrative planning for relevant documents
Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
Collaborates with clinicians, clinical scientists, biostatisticians, and pharmacokineticists to interpret study results and ensure study results and statistica

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