Medical Writer (f/m)
bioskin is a full-service CRO specialized in dermatology, working in an international environment. We are looking for an experienced Medical Writer to join our team at bioskin in Hamburg as soon as possible. The Medical Writer's essential function is to generate clear, comprehensive, carefully focused and precise documents at bioskin in cooperation with all involved departments. Documents are to be standards-compliant, quickly and easily read and understood by scientific, medical and regulatory professionals. 
 
Focus of tasks:
  • Clinical Study Reports (CSRs) according to ICH-E3 for single and multicenter trials
  • Preparation of appendices for CSRs
  • Linking and bookmarking processes
  • CSRs in Common Technical Document (CTD) or electronic Common Technical Document (eCTD) for application dossier
  • Research reports for non-drug studies, as well as abbreviated reports
  • Study protocols, subject information leaflets
  • Scientific publications (journal articles, abstracts, posters)
  • Editing and review of documents assuring that documents comply with regulatory, journal, or other guidelines in terms of content, format and structure
  • Investigational Medicinal Product Dossier
  • Investigator's Brochure
  • Regulatory documentation (IND, briefing packages, etc.)

Profile:

  • Degree in a scientific or medical discipline
  • At least 2 years of experience in medical writing within the area of clinical trials/clinical research
  • Well-structured and organized, target-oriented personality, team player
  • Very good writing skills and medical knowledge
  • Very well versed in English (written and spoken)
  • Comfortable with statistics, translating statistical findings in a way that makes sense toward readership and audiences, clarification of complex ideas in simple language, and target messages
  • Logical and accurate with data and results interpretation and representation
  • Working knowledge of ICH-GCP guidelines
  • Candidates with experience in dermatology will be preferred

Contacts by headhunters, recruiting or staffing agencies are not accepted!

Please send your complete application including your anticipated salary to

bioskin GmbH • Burchardstraße 17 • 20095 Hamburg • Germany
Bettina Möhlenbrock • bewerbung@bioskinCRO.com
Please send applications by e-mail as pdf file.
Clinical Trial Manager (f/m)
We are looking for a Clinical Trial Manager with long-standing experience to join our team at bioskin in Hamburg. The Clinical Trial Manager's essential function is to organize and manage clinical studies at bioskin, coordinating all involved departments at bioskin as well as external vendors, and being the window person for the sponsor.

Focus of tasks:
  • Planning and coordinating of clinical trials at bioskin
  • Clinical trial setup
  • Generation of essential documents (trial protocols, subject information, regulatory documents)
  • Clinical Trial Application to ethics committees and authorities
  • Management of involved parties
  • TMF maintenance
  • Budget responsibility

Profile:

  • Degree in a scientific or medical discipline
  • At least 3 years of experience in the area of clinical trial management or clinical research, ideally multicenter and multinational trial experience
  • Strong organziational and communication skills
  • Well-structured and organized, target-oriented personality, team player
  • Very good English skills
  • Candidates with experiences in dermatology will be preferred

Contacts by headhunters, recruiting or staffing agencies are not accepted!

Please send your application including your anticipated salary to

bioskin GmbH • Burchardstraße 17 • 20095 Hamburg • Germany •
Bettina Möhlenbrock • bewerbung@bioskinCRO.com
Please send applications by e-mail as pdf file.
Clinical Trial Management Assistant (f/m)
We are looking for a Clinical Trial Management Assistant to join our team at bioskin in Hamburg. The Clinical Trial Management's essential function is to support the organization and management of clinical trials at bioskin, correspond with internal and external Partners and vendors and support the trial team in all administrative tasks in the context of clinical trials. 

Focus of tasks:
  • Support the trial team in all aspects of the organization and management of clincial trials according to ICH-GCP, applicable regulations and SOPs
  • Support the Trial team in generating and updating trial related documents and manuals
  • Provide support in compilation and submission of packages for clinical trial applications to authorities and ethics committees
  • Set up, maintain and review trial master files including supporting quality control of documents
  • Accurately monitor, update and maintain Trial status and overview lists
  • Support the organization and coordication of internal and external meetings
  • Prepare and review meeting minutes

Profile:

  • Scientific Degree, Medical documentation officer certification or equivalent Medical, scientific or pharmaceutical education
  • Experience in the area of clinical trial management or clinical research, ideally multicenter and multinational trial experience
  • Strong organziational and communication skills; team spirit
  • Ability to work in a structured manner, experience in dealing with external parties, good time management
  • Results-oriented approach, flexible and proactive attitude towards changing needs; willingness to work on different projects simultaneously
  • Very good English skills, both written and spoken
  • Knowledge of the current national and international laws and guidelines regarding the conduct of clinical trials

Contacts by headhunters, recruiting or staffing agencies are not accepted!

Please send your application including your anticipated salary to

bioskin GmbH • Burchardstraße 17 • 20095 Hamburg • Germany •
Bettina Möhlenbrock • bewerbung@bioskinCRO.com
Please send applications by e-mail as pdf file.
Dermatologist (f/m)
bioskin is a full-service CRO specialized in dermatology, working in an international environment. We are looking for a dermatologist to join our clinical team in Hamburg in an either part or full time position. 
 
Focus of tasks:
  • Provides medical input during development of clinical trial protocols 
  • Investigator in clinical trials, working according to clinical trial protocol, ICH-GCP and local regulations
  • Attends to patients within the scope of clinical trials
  • Performs physical exams, dermatological evaluation of skin disease severity, scoring of skin tolerability, sonographical and biophysical measurements 
  • Evaluates lab and ECG reports
  • Assesses any adverse events of investigative medicinal products
  • Participates in study initiation and monitoring visits as well as sponsor audit visits 
  • Contact for clinical team and sponsor regarding medical issues
  • Performs medical monitoring over subject safety data

Profile:

  • Licensed physician and board certified dermatologist
  • Experience in conducting clinical research
  • Knowledge of ICH-GCP as well as applicable local regulations (AMG, MPG)
  • Versed in MS Office
  • Dependable, thorough, well-structured and organized, team player
  • Fluent German and very good English skills (written and spoken)

Contacts by headhunters, recruiting or staffing agencies are not accepted!

Please send your complete application including your anticipated salary to

bioskin GmbH • Burchardstraße 17 • 20095 Hamburg • Germany
Bettina Möhlenbrock • bewerbung@bioskinCRO.com
Please send applications by e-mail as pdf file.

Unsolicited applications

If we do not have an available job posted which matches your needs, you are always welcome to take the initiative and send us an unsolicited application.

Please send your unsolicited application to:
Hamburg headquarters address:
bioskin® GmbH
Burchardstrasse 17 · 20095 Hamburg, Germany
Phone: +49-40-606897-0 · Fax: +49-40-606897-30

bewerbung@bioskinCRO.com