Aktuelle Jobs im Zusammenhang mit Director of Scientific Writing - Berlin - X4 Communications
-
Freelance Scientific Writing Instructor
vor 3 Wochen
Berlin, Berlin, Deutschland University of Europe for Applied Sciences VollzeitJob Opportunity: Freelance Scientific Writing InstructorThe University of Europe for Applied Sciences (UE) is a leading institution in the field of higher education, dedicated to providing top-quality education to students from around the world. Our programs are delivered in English and/or German language, and with over 100 nationalities represented on...
-
Freelance Scientific Writing Instructor
vor 3 Wochen
Berlin, Berlin, Deutschland University of Europe for Applied Sciences VollzeitJob Opportunity: Freelance Scientific Writing InstructorThe University of Europe for Applied Sciences (UE) is a leading institution in the field of higher education, dedicated to providing top-quality education to students from around the world. Our programs are delivered in English and/or German language, and with over 100 nationalities represented on...
-
Freelance Scientific Writing Instructor
vor 3 Wochen
Berlin, Berlin, Deutschland University of Europe for Applied Sciences VollzeitAbout the RoleWe are seeking a highly skilled Freelance Scientific Writing Instructor to join our team at the University of Europe for Applied Sciences (UE). As a Freelance Scientific Writing Instructor, you will be responsible for teaching pre-bachelor students the skills to write scientific papers in APA format and exploring various scientific writing...
-
Freelance Scientific Writing Instructor
vor 3 Wochen
Berlin, Berlin, Deutschland University of Europe for Applied Sciences VollzeitAbout the RoleWe are seeking a highly skilled Freelance Scientific Writing Instructor to join our team at the University of Europe for Applied Sciences (UE). As a Freelance Scientific Writing Instructor, you will be responsible for teaching pre-bachelor students the skills to write scientific papers in APA format and exploring various scientific writing...
-
Freelance Scientific Writing Instructor
vor 2 Wochen
Berlin, Berlin, Deutschland University of Europe for Applied Sciences VollzeitJob Opportunity: Freelance Scientific Writing InstructorThe University of Europe for Applied Sciences (UE) is a leading institution in the field of higher education, dedicated to providing top-quality education to students from all around the world. Our programmes are delivered in English and/or German language, and with more than 100 nationalities...
-
Freelance Scientific Writing Instructor
vor 2 Wochen
Berlin, Berlin, Deutschland University of Europe for Applied Sciences VollzeitJob Opportunity: Freelance Scientific Writing InstructorThe University of Europe for Applied Sciences (UE) is a leading institution in the field of higher education, dedicated to providing top-quality education to students from all around the world. Our programmes are delivered in English and/or German language, and with more than 100 nationalities...
-
Berlin, Deutschland University of Europe for Applied Sciences VollzeitThe University of Europe for Applied Sciences (UE) is a vibrant and dynamic institution that is dedicated to providing top-quality education to students from all around the world. Our programmes are delivered in English and/or German language, and with more than 100 nationalities represented on campus, we are proud to have one of the most diverse student...
-
Medical Director
vor 4 Monaten
Berlin, Deutschland atai Vollzeit**Contract Duration**: 12 months **Work Hours**: 40 hours/week **Position Type**: Fixed-term contract **Location**:DE / UK The Medical Director/Senior Director is responsible for working cross-functionally to oversee/co-lead the design and development of Phase 1-3 clinical trials. The Clinical Development Director must be highly innovative and take bold...
-
Scientific Director
vor 3 Wochen
Berlin, Berlin, Deutschland Vivantes – Netzwerk für Gesundheit GmbH VollzeitJob Title: Scientific DirectorJob DescriptionConduct and evaluate specialized technologies and methods, including flow cytometry, to generate accurate results.Develop and implement quality management concepts and strategies to ensure compliance with laboratory standards.Manage administrative tasks, such as proficiency testing, result transfers, and...
-
Scientific Director
vor 4 Wochen
Berlin, Berlin, Deutschland Vivantes – Netzwerk für Gesundheit GmbH VollzeitJob Title: Scientific DirectorJob DescriptionConduct and evaluate specialized technologies and methods, including flow cytometry, to generate accurate results.Develop and implement quality management concepts and strategies to ensure compliance with laboratory standards.Manage administrative tasks, such as proficiency testing, result transfers, and...
-
Director of Quality and Regulatory Compliance
vor 2 Wochen
Berlin, Berlin, Deutschland EPM Scientific VollzeitQuality and Regulatory Affairs ExpertEPM Scientific is seeking a highly skilled Quality and Regulatory Affairs expert to join our team. As a key member of our organization, you will play a critical role in ensuring the highest standards of quality and regulatory compliance in the development and delivery of medical devices.Key Responsibilities:Develop,...
-
Director of Quality and Regulatory Compliance
vor 2 Wochen
Berlin, Berlin, Deutschland EPM Scientific VollzeitQuality and Regulatory Affairs ExpertEPM Scientific is seeking a highly skilled Quality and Regulatory Affairs expert to join our team. As a key member of our organization, you will play a critical role in ensuring the highest standards of quality and regulatory compliance in the development and delivery of medical devices.Key Responsibilities:Develop,...
-
Director of Quality and Regulatory Compliance
vor 2 Wochen
Berlin, Berlin, Deutschland EPM Scientific VollzeitQuality and Regulatory Affairs ExpertEPM Scientific is seeking a highly skilled Quality and Regulatory Affairs expert to join our team. As a key member of our organization, you will play a critical role in ensuring the highest standards of quality and regulatory compliance in our medical technology products.Key Responsibilities:Develop, revise, and maintain...
-
Director of Quality and Regulatory Compliance
vor 2 Wochen
Berlin, Berlin, Deutschland EPM Scientific VollzeitQuality and Regulatory Affairs ExpertEPM Scientific is seeking a highly skilled Quality and Regulatory Affairs expert to join our team. As a key member of our organization, you will play a critical role in ensuring the highest standards of quality and regulatory compliance in our medical technology products.Key Responsibilities:Develop, revise, and maintain...
-
Director of Quality and Regulatory Compliance
vor 2 Wochen
Berlin, Berlin, Deutschland EPM Scientific VollzeitQuality and Regulatory Affairs ExpertEPM Scientific is seeking a highly skilled Quality and Regulatory Affairs expert to join our team. As a key member of our organization, you will play a critical role in ensuring the highest standards of quality and regulatory compliance in our medical technology products.Key Responsibilities:Develop, revise, and maintain...
-
Director of Quality and Regulatory Compliance
vor 2 Wochen
Berlin, Berlin, Deutschland EPM Scientific VollzeitQuality and Regulatory Affairs ExpertEPM Scientific is seeking a highly skilled Quality and Regulatory Affairs expert to join our team. As a key member of our organization, you will play a critical role in ensuring the highest standards of quality and regulatory compliance in our medical technology products.Key Responsibilities:Develop, revise, and maintain...
-
Director of Quality and Regulatory Compliance
vor 2 Wochen
Berlin, Berlin, Deutschland EPM Scientific VollzeitQuality and Regulatory Affairs SpecialistEPM Scientific is seeking a highly skilled Quality and Regulatory Affairs Specialist to join our team. As a key member of our organization, you will be responsible for ensuring the highest standards of quality and regulatory compliance in our medical device development process.Key Responsibilities:Develop and maintain...
-
Director of Quality and Regulatory Compliance
vor 2 Wochen
Berlin, Berlin, Deutschland EPM Scientific VollzeitQuality and Regulatory Affairs SpecialistEPM Scientific is seeking a highly skilled Quality and Regulatory Affairs Specialist to join our team. As a key member of our organization, you will be responsible for ensuring the highest standards of quality and regulatory compliance in our medical device development process.Key Responsibilities:Develop and maintain...
-
Director of European Strategies
vor 4 Monaten
Berlin, Deutschland Institute for Agriculture and Trade Policy VollzeitThe Institute for Agriculture and Trade Policy (IATP) is looking for a full-time Director of European Strategies in our Berlin, Germany office. **Our Mission** IATP works locally and globally at the intersection of policy and practice to ensure fair and sustainable food, farm, and trade systems. **Who are you?** You are committed to systemic solutions...
-
Director (M/w/d) Scientific Communication & Medical
vor 4 Monaten
Berlin, Deutschland Pfizer VollzeitWeltweit arbeiten die Mitarbeiter:innen von Pfizer gemeinsam daran, die Gesundheit eines jeden Einzelnen überall zu verbessern. Während wir Arzneimittel und Medizin-Produkte entwickeln und unser Geschäft global ausweiten, halten wir jederzeit Ausschau nach neuen Talenten. Derzeit suchen wir Sie in Berlin als: Director (m/w/d) Scientific Communication &...
Director of Scientific Writing
vor 4 Monaten
Director of Scientific/Medical Writing
A German biotechnology company is looking for a German based Director of Scientific Writing to join the team who has over 8+ years experience within the Pharma or Biotech space. Whilst you will oversee a team they are looking for someone who is also happy to get hands on
Main Responsibilities:
Team Leadership:
- Create and maintain a cohesive, collaborative, and innovative team of scientific/medical writers (you will be have 6 direct reports).
- Act as a role model by performing scientific/medical writing tasks for documents of varying complexity, including marketing approval modules for novel oncology and infectious disease therapies.
Document Preparation:
- Independently perform scientific/medical writing tasks for complex documents.
- Coordinate the preparation, review, and approval of documents.
- Write, edit, and format a wide range of regulatory documents required for clinical development and post-approval life cycle management, such as clinical study protocols, clinical study reports, investigator’s brochures, eCTD summaries, clinical overviews, briefing books, and response documents.
Process Development:
- Create and implement standards and processes in the absence of suitable ones to meet team objectives.
- Coordinate and manage teams of writers and subject matter experts preparing dossiers for marketing approval and life cycle management of approved products.
Regulatory Interaction:
- Leverage extensive experience in interacting with regulatory authorities to ensure timely and successful responses to authority questions and requests.
- Ensure the optimal presentation of complex information to make dossiers persuasive and convincing.
Expertise and Leadership:
- Develop and implement tools, guidelines, SOPs, and templates relevant to the role.
- Define company strategies and standards for regulatory documents supporting clinical development, marketing approval, and post-approval life cycle management.
- Line manage a team of up to 6 scientific/medical writers, including recruitment, supervision, mentoring, and development.
- Support, train, and guide subject matter experts on good writing practices and the structure and formatting requirements for scientific/regulatory documents.
You will excel in this role if you have:
- A relevant life science university degree (ideally M.D., Pharm.D., or Ph.D.) with a background in immunology and oncology.
- Over 8 years of experience in drug development, preferably in oncology, immunology, or vaccines.
- More than 8 years of experience as a scientific or medical writer in the pharmaceutical/biotech industry or vendor setting.
- Native-level proficiency in written and spoken English; good German skills are advantageous.
- Prior line management experience
- Advanced knowledge of regulations/guidance on the structure, format, and content of regulatory documents (e.g., ICH E3, E6, E9), technical specifications (e.g., ICH M4), the drug development process, and the needs of relevant stakeholders.
- Advanced knowledge of statistics, study design, data reporting, and relevant experimental models.
They have multiple locations across Germany, so if you are located in Germany and interested in the above we definitely want to hear from you
