A vibrant medical writing department within a global data-focused clinical research organization (CRO) is recruiting for the role of Mid-level Medical Writer to support a US-based large Pharmaceutical Company in addition to picking up projects within-house, based on availability.
The role includes writing clinical study protocols, clinical study reports, investigator's brochures, CTD summary documents and others.
The CRO culture is very supportive, and strong emphasis is put on employee training as well as welfare. The client company has a strong medical writing group and is a leader in its scientific field.
Company headquarters are in Israel and there are offices in South Africa, Australia and the US. The mid-level medical writer position is a full- time, permanent, remote position.
Prospective candidates to be based in Israel, South Africa, continental Europe, UK, East Coast of USA, East Coast of Canada or East Coast of Central America. No relocation package is offered and Bioforum will only consider candidates who already reside in the aforementioned areas and are legally able to work in their country of residence.
Responsibilities:
- Writing non-complex regulatory documents including, but not limited to clinical study protocols, clinical study reports, investigator brochures, in various therapeutic areas, with minimal oversight.
- Writing more-complex documents including clinical summary CTD documents under supervision.
- Supporting an external client who is a large US-based Pharmaceutical Company as a medical writer, writing documents, not limited to clinical study protocols, clinical study reports, informed consent forms. investigator brochures, and others.
- Organizing and leading cross-functional document review meetings, clarifying client’s comments and incorporating feedback, and moderating cross-functional differences of opinion
- Editing and review of documents and other client deliverables
- Review and editing of other Bioforum documents related to Medical Writing projects
Reports to Senior Director, Global Medical Writing, Bioforum group.
Requirements:
- Ph.D. or equivalent in any of the biomedical sciences (eg, life sciences, pharmacy, medicine)
- At least 3 years (3 - 6 years, preferable) of experience in medical writing in the pharmaceutical domain
- Experience in writing regulatory documents (clinical study protocols and reports, informed consent forms, Investigator brochures, etc.)
- Working knowledge of relevant regulatory guidances
- Experience in writing summary CTD documents would be considered a strong asset
- Medical Writing Certification will be considered a strong asset