Medical Writer

Debiopharm, a privately-owned Swiss biopharmaceutical company, is seeking a highly skilled Medical Writer to join its Clinical Development organization based in Lausanne. As a Medical Writer, you will play a crucial role in developing and reviewing Study documents for Global Clinical Studies, primarily for Oncology programs.

Key Responsibilities:

• Develop and review clinical and regulatory documents, including Clinical Trial Protocols, Informed Consent Forms, Clinical Study Reports, Investigator's Brochures, and regulatory documents, ensuring compliance with international requirements.
• Collaborate closely with internal specialists, colleagues, and departments to obtain and 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 for accuracy, quality, focus, and adherence to format and stylistic requirements.
• Drive process improvement and/or cross-functional initiatives, such as SOP review and template development.
• Develop the strategy for document preparation and the document review processes, collaborating closely with teams to better understand needs, planning, and timelines, and facilitating document review meetings and discussions.
• Provide advice on the development and implementation of best practices in medical writing, contributing to initiatives aiming to use AI/digital tools to support medical writing.
• Ensure understanding and implementation of international quality standards, such as ICH GCP, and internal company procedures.

Requirements:

• Master's Degree required, advanced Clinical/Science Degree 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 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.

The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. The Human Resources Department at Debiopharm requests external staffing agencies or recruiters not to contact Debiopharm employees or members of the Board of Directors directly in an attempt to present candidates.

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.

Debiopharm will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.