A vibrant medical writing department within a global data-focused clinical research organization (CRO) is recruiting for the role of Senior Medical Writer.
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 and well-being. The client company has a strong medical writing group and is a leader in its scientific field.
CRO headquarters are in Israel and there are offices in South Africa, Australia and the US.
The senior medical writer position is a full- time, permanent, remote position. Prospective candidates to be based in Israel, 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:
Bioforum Responsibilities
- Draft regulatory documents, including clinical study protocols, reports, and investigator brochures, across various therapeutic areas with minimal supervision.
- Prepare complex documents, such as clinical summary CTD documents, under guidance.
- Support Bioforum’s medical writing projects by reviewing and editing internal documents.
- Ensure compliance with internal training, guidelines, templates, and SOPs for therapeutic area-specific documents.
Client-Specific Responsibilities
- Collaborate with a US-based pharmaceutical client to produce clinical documents, including study protocols, reports, informed consent forms, and investigator brochures.
- Participate in process improvement initiatives and working groups within the medical writing team and global development.
- Oversee junior and outsourced medical writers by reviewing their work and mentoring as needed.
- Review CSR-related materials, such as statistical analysis plans and TFLs, to confirm appropriate inclusion.
- Create plain language documents where required, explaining complex medical or scientific concepts for lay or patient audiences.
- Facilitate and lead cross-functional document review meetings, clarify client feedback, and integrate comments effectively.
- Review and edit documents and deliverables to ensure quality and accuracy.
- Represent the client’s medical writing department in meetings and discussions.
- Develop and articulate document strategies and timelines.
- Resolve content-related discussions efficiently and succinctly synthesize outcomes into clear, accurate text.
Reports to Senior Director, Global Medical Writing, Bioforum group.
Requirements:
- Academic degree in any of the biomedical sciences (eg, life sciences, pharmacy, medicine). A graduate degree will be considered as advantage.
- At least 5 years (5-8 years, preferable) of experience in medical writing in the pharmaceutical domain
- Proven experience in authoring regulatory documents (clinical study protocols and reports, informed consent forms, Investigator brochures, etc.) in the pharmaceutical industry
- Working knowledge of relevant regulatory guidance documents including ICH E3, ICH E6, ICH M4E
- Experience in writing summary CTD documents would be considered a strong asset
- Strong organizational, interpersonal and communication skills
- Strong knowledge of MS WORD, Adobe Acrobat, PowerPoint, and electronic document management systems
- Ability to manage multiple projects
- A Medical Writing Certification will be considered a strong asset