About the Company
Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO,andmulti-therapeutic integral functional and CRO services through Catalyst Flex. The company's customer‑centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies.
Position Overview
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

📌 Principal Medical Writer (España)
🏢 Catalyst Clinical Research
📍 España