Senior Medical Writer

Clinical DevelopmentLausanne, Vaud, SwitzerlandFull time

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Description

Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and bacterial infections in order to improving 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. Bridging the gap between disruptive discovery products and real-world patient reach, we 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.

Here: apply.workable.com/debiopharm-group-sa/

Debiopharm International S.A. identifies high-potential compounds for in-licensing, conducts clinical development and then selects large pharmaceutical commercialization partners to maximize patient access across the globe.

For our Clinical Development organization based at our Headquarters in Lausanne, we are looking for a

Senior Medical Writer (100%)

As Senior 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:

• Author and review clinical and regulatory documents such as Study Protocols, ICFs, CSRs, IBs, Pediatric Investigation Plans, Briefing Books, Requests of Product Specific Waivers, applications for Orphan Drug Designations, and responses to Health Authorities; the documents should be accurate, suited for the intended audience and easy to read


• 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 & 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

• Master's Degree required, advanced Clinical/Science Degree is preferred (e.g. PhD, MD, etc.).


• 7 years experience supporting the development of Study Protocols, Protocol Amendments, Briefing Books, IBs, CSRs or ICFs in Pharmaceuticals


• 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


• Fluency in English and solid writing/editorial skills


• 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


• Self-starter, flexible in adapting to changing circumstances or new information, able to adapt quickly in a fast-moving environment.


• Attention to detail, accuracy, and logical organization. Expert grammatical and communication skills, both written and oral

Benefits

• An international and highly dynamic environment, with a long term vision.


• The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry and be exposed to many areas within clinical development and the pharmaceutical industry.


• The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.

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.

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