P2419 - Medical Writer
Vor 2 Tagen
**_Debiopharm_**_ is privately-owned Swiss biopharmaceutical company commitmented to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Debiopharm International SA aims to develop innovative therapies via our unique “development only” business model, acting as a bridge between disruptive discovery products and patient access in international markets. At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases through working on innovative medicines for patients. Join our team at Debiopharm where together, we innovate, we impact, and we grow._
For our Clinical Development organization based at our Headquarters in Lausanne, we are looking for a
**Medical Writer**
As Medical Writer (MW), you develop and review Study documents for Global Clinical Studies mainly for Oncology programs, including the Protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), Investigator's Brochures (IBs) and regulatory documents, ensuring compliance with international requirements.
As part of the role, you also coordinate the process of reviews, the reconciliation of comments, the document finalization and approval.
**Your responsibilities will be but not limited to**:
- Development of clinical and regulatory documents such as Clinical Trial Protocols, ICFs, CSRs, IBs, and other clinical documents; with the aim to deliver accurate documents, suited for the intended audience and easy to read.
- Collaborate closely with internal specialists/colleagues/departments to obtain/provide information, ensure smooth review processes, incorporate editorial comments, and solve queries to present a 'finished' final document within the required deadline.
- Review work of other writers (internal functional area representatives or contractors) for accuracy, quality, focus, and adherence to format and stylistic requirements.
- Drive process improvement and/or cross-functional initiatives (e.g., SOP review, template development).
- Develop the strategy for document preparation and the document review processes: you collaborate closely with the teams to better understand the needs, the planning, and timelines; and facilitate document review meetings and discussions.
- Provide advice in the development and implementation of best practices in medical writing. You may contribute to initiatives aiming to use AI/digital tools to support medical writing.
- Ensure understanding and implementation of international quality standards (e.g., ICH GCP) and internal company procedures.
**Requirements**:
- Master's Degree required, advanced Clinical/Science Degree is preferred (e.g., PhD, etc.). Oncology experience is a plus.
- At least three years of experience supporting the development of Clinical Trial Protocols, Protocol Amendments, ICFs, IBs, and/or CSRs in Pharmaceuticals. Oncology experience is a plus.
- Strong knowledge of guidelines (e.g., ICH, EMA, FDA, etc.) used for the preparation of clinical documents.
- Knowledge of the clinical drug development process, clinical trial design, and biostatistics.
- Strong experience integrating information into clinical and regulatory documents.
- Self-starter, flexible in adapting to changing circumstances or new information, able to adapt quickly in a fast-moving environment.
- Tech-savvy, curiosity for new digital/AI tools and interest to leverage them.
- Ability to prioritize and manage multiple demands and projects within deadline.
- Good command of MS Word.
- Good presentation skills and ability to interpret and present data in a logical manner.
- Attention to detail, accuracy, and logical organization. Expert grammatical and communication skills in English, both written and oral.
**Benefits**
**Debiopharm offers employees**:
- International, highly dynamic environment with a long-term vision
- Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry
- Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry
- Participation in a company where innovation, people and entrepreneurship are the fundamental keys to success
- Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities
- Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm._
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