Medical Writer
Vor 2 Tagen
**_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._
-
Medical Writer
vor 23 Stunden
Lausanne, Schweiz LHH VollzeitLHH Recruitment Solutions is a specialized talent recruitment agency. With deep industry expertise and a commitment to excellence, LHH is a trusted partner in Switzerland for many years. Our client is an innovative MedTech company in Lausanne. **Responsibilities**: - Write and edit a wide range of medical and scientific content - clinical study reports,...
-
Medical Writer
Vor 2 Tagen
Lausanne, Schweiz Debiopharm VollzeitDescription 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...
-
P2419 - Medical Writer
vor 23 Stunden
Lausanne, Schweiz Debiopharm VollzeitDescription 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...
-
P2419 - Medical Writer
vor 23 Stunden
Lausanne, Schweiz Debiopharm Vollzeit**_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...
-
Lausanne, Schweiz Debiopharm VollzeitDescription 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...
-
P2419 - Medical Writer
vor 1 Tag
Lausanne, Schweiz Debiopharm VollzeitDebiopharm 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...
-
P2419 - Medical Writer, Lausanne
Vor 2 Tagen
Lausanne, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Debiopharm is a privately-owned Swiss biopharmaceutical company committed 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...
-
Lausanne, Schweiz Volumina Medical VollzeitAssociate – Pharma/Medical Devices • Full time, 100% Based in Lausanne (Biopôle Epalinges and EPFL) – travel time: up to 30% 1-year contract, possibly renewable for a total of 2.5 years Volumina Medical is a start-up, spin-off of the Swiss Federal Institute of Technology (EPFL), active in the field of medical devices. The company develops...
-
Chief of Staff
Vor 3 Tagen
Lausanne, Schweiz GTX medical VollzeitAt ONWARD we're looking for a Chief of Staff to join our team. Full-time - Lausanne **About the job**: This is a unique opportunity for an individual with senior leadership aspirations to get exposure to a broad array of business issues and deliver value to the organization across our spectrum of activities. The Chief of Staff will support the Chief...
-
Graduate Assistant in Bacterial Genetics
Vor 5 Tagen
Lausanne, Schweiz Université de Lausanne Vollzeit**Introduction**: The University of Lausanne is a higher teaching and research institution located right by the Geneva lake overlooking the Alps in Switzerland. It is composed of seven faculties, including a Faculty of Biology and Medicine training biologists/medical doctors and performing internationally recognized research projects in the fields of...
-
Lausanne, Schweiz Unilabs Switzerland VollzeitIntroductionUnilabs is the largest provider of medical laboratory diagnostics for prescribers and hospitals in Switzerland and employs around 800 people.Your TasksPromote and embody the company vision and policies while maintaining the genetic laboratory’s licensure and accreditations. Manage and enhance the Quality Management System (QMS) in compliance...
-
Pharmaceutical Communication Intern
Vor 2 Tagen
Lausanne, Schweiz Debiopharm VollzeitDescription 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...
-
Lausanne, Schweiz Unilabs Group Services VollzeitUnilabs is the largest provider of medical laboratory diagnostics for prescribers and hospitals in Switzerland and employs around 800 people.Your TasksPromote and embody the company vision and policies while maintaining the genetic laboratory’s licensure and accreditations. Manage and enhance the Quality Management System (QMS) in compliance with ISO...
-
Associate Scientist, Nonclinical Dmpk
vor 2 Wochen
Lausanne, Schweiz Debiopharm VollzeitDescription Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and bacterial infections 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...
-
Clinical Scientist
Vor 2 Tagen
Lausanne, Schweiz Galderma VollzeitWith a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology. We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all,...
