Medical Writer
Vor 2 Tagen
Description
Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique “development only” business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.
At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target.
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.
**Main responsibilities**:
Review work of other writers (contractors or internal functional area representatives) 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.
Trigger annual IB reviews and updates.
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.
Ensure understanding and implementation of international quality standards (ICH GCP) and internal company procedures.
Facilitate document review meetings and discussions.
Contribute to the development of project timelines
**Requirements**:
**Your profile**:
Master's Degree required, advanced Clinical/Science Degree is preferred (e.g. PhD, MD, etc.).
At least three years of experience supporting the development of Study Protocols, Protocol Amendments, Briefing Books, IBs, CSRs or ICFs in Pharmaceuticals. Oncology experience is a plus.
Strong experience of writing guidelines (e.g. EMA, FDA, ICH, AMA, etc.) used for the preparation of clinical documents.
Strong working knowledge of the clinical drug development process, clinical trial design and biostatistics.
Strong experience integrating information into clinical and regulatory documents.
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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