Job Offers

 


Medical Writer - Senior

Munich, Germany

 

This position covers medical writing activities across all phases of development for small molecules, biologicals, cell based and modern targeted/personalized therapies. Experience in any of these areas is a prerequisite.

 

Tasks & Responsibilities:

 

  • Authoring high-quality regulatory documents
  • Such as IB, CTD summary documents (2.6, 2.7) and overviews (2.4, 2.5)
  • Orphan Drug applications, RMPs, and PIPs
  • Compilation of any documentation required for approval and conduct of clinical studies. Documentation to support agency meetings (briefing books, presentations)

 

Requirements:

 

  • Advanced degree in life sciences, medicine or veterinary medicine
  • Broad experience in medical writing (>5 years) on wide range of regulatory documents
  • Understanding of FDA and ICH regulations and guidelines
  • Ability to work independent, analyse and summarise data (clinical, non-clinical, quality)
  • Ability to manage multiple tasks simultaneously under time constraints
  • Excellent communication skills in English and a second language, preferably German
  • Strong knowledge of Microsoft Office and graphical software

 

We offer:

A professional and friendly working environment located in Munich. Working together with a dedicated small and effective team, we provide an outstanding and more than competitive salary, with a very attractive bonus system tailored to your expertise and our business success.

 

Contact:

If you are interested please send your application documents to Dr. Stefan Blesse, blesse@granzer.biz

 

Preclinical Consultant - Senior

Munich, Germany

 

This function covers all non-clinical topics from early development, i.e. concerning transition from research to development including nonclinical requirements for FIM studies, selection of and collaboration with CROs for conduct of non-clinical studies, and non-clinical requirements including dossier preparation for MAA or BLA/NDA filing.

 

Tasks & Responsibilities:

 
  • Provide advice to clients on non-clinical aspects of drug development and regulatory requirements in collaboration with CMC and clinical experts in the Granzer team
  • Ensure that the content of non-clinical documents is appropriate, meets regulatory expectations and enables approval of regulatory submissions
  • Prepare non-clinical development plan
  • Perform gap analyses of development packages provided by clients
  • Support due diligence processes
  • Support clients in meetings with regulatory agencies and moderate such meetings
  • Prepare IBs for CTA
  • Prepare responses to deficiency letters in collaboration with CMC and clinical experts in the Granzer team
  • Prepare briefing packages for meetings with regulatory agencies (national regulatory agencies, EMA and FDA)
  • Continuously check scientific and regulatory guidance

 

Requirements:

 

  • Degree in medicine/veterinary medicine, pharmacy or biology/biochemistry/chemistry
  • More than ten years of experience in the pharmaceutical industry in a position in research, non-clinical development or regulatory affairs
  • Knowledge of  in non-clinical and regulatory requirements for all stages of drug development
  • Experience in the preparation of regulatory documentation related to CTA, MAA, IND, BLA/NDA
  • Excellent communication and negotiation skills in English
  • Highly motivated team player with strong interpersonal abilities
  • Sound knowledge of Microsoft Office applications
  • Willingness to travel moderately (meetings with clients, regulatory agencies or CROs

 

We offer:

A professional and friendly working environment located in Munich. Working together with a dedicated small and effective team, we provide an outstanding and more than competitive salary, with a very attractive bonus system tailored to your expertise and our business success.

 

Contact:

If you are interested please send your application documents to Dr. Stefan Blesse, blesse@granzer.biz

 

CMC Consultant

Munich, Germany

 

The Consultant CMC is the quality expert in the Granzer team, providing knowledge on broad range of drug substances (from small molecules to synthetic oligonucleotides to biologicals) and drug products (from solid orals to sterile solutions to nanoparticulate formulations). This function will cover all quality related topics from pre-clinical development to approved commercial products.

 

Tasks & Responsibilities:

 
 
  • Provide advice to clients on quality aspects of drug development and regulatory requirements, in close collaboration with cross-functional experts from the team
  • Ensure that the content of CMC work-packages and documentation are phase appropriate, meet regulatory expectations and enable approval of regulatory submissions
  • Preparation of quality sections for MAA and BLA/NDA as well as for IMPD and IND
  • Perform gap analyses of client-provided packages. Identify critical CMC development issues and develop strategies for their resolution
  • Support due diligence processes
  • Prepare briefing packages for agency meetings (e.g. scientific advice, oral explanation, EoP2) and conduct such meetings together with the client
  • Management of operational and strategical aspects with CDMOs
  • Coordination of filing activities within the cross-functional Granzer team and with contributing parties
  • Continued observance of regulatory guidance and regulations

 

Requirements:

 

  • Ph.D. or master’s degree in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology or comparable
  • At least five years in a scientific/technical CMC development or CMC – regulatory affairs function
  • Experience with regulatory filings (IND/IMPD, BLA/NDA/MAA).
  • Excellent communication and negotiation skills in English. German language skills are a plus
  • Experience with CMC and regulatory requirements for all development stages, from pre-clinical to Phase III or commercial
  • Highly motivated team player with strong interpersonal abilities
  • Sound knowledge of Microsoft Office applications
  • Willingness to travel moderately (Meetings with clients, agencies or CMOs)

 

We offer:

A professional and friendly working environment located in Munich. Working together with a dedicated small and effective team, we provide an outstanding and more than competitive salary, with a very attractive bonus system tailored to your expertise and our business success.

 

Contact:

If you are interested please send your application documents to Dr. Stefan Blesse, blesse@granzer.biz

 

CMC Technical Writer

Munich, Germany

 

The Consultant “CMC Technical Writer” supports the quality experts in the Granzer team by writing core quality sections for chemical, biological, cell-based and gene therapy products that are presented in various dosage forms.

 

Tasks & Responsibilities:

 

  • Review of GMP source documents such as batch records or validation reports
  • Authoring and review and of high-quality reports, such as comparability reports
  • Authoring and review of documents for CTD Modules 1, 2.3 and 3 for IMPDs/INDs and MAAs/BLAs/NDAs
  • Authoring of documentation to support regulatory agency meetings in the US and EU (briefing books, presentations)

 

Requirements:

 

  • Ph.D. or master’s degree in Pharmacy, Chemistry, Biochemistry, Biology, Biotechnology or comparable
  • At least 3 years’ experience in technical CMC writing, thereof at least 2 years’ authoring experience for INDs, IMPDs, BLAs, NDAs or MAAs
  • Knowledge of technical/regulatory requirements for at least one of the product classes listed above
  • Excellent writing and communication skills in English. German language skills are a plus
  • Sound knowledge of Microsoft Office applications

 

We offer:

A professional and friendly working environment located in Munich. Working together with a dedicated small and effective team. We provide an outstanding and more than competitive salary, with a very attractive bonus system tailored to your expertise and our business success.

 

Contact:

If you are interested please send your application documents to Dr. Stefan Blesse, blesse@granzer.biz

 

Consultant Drug-Device

Munich, Germany

 

The Consultant “Medical Device” supports the device parts of drug-device combination products, In Vitro diagnostics and companion diagnostics in a drug development environment.

 

Tasks & Responsibilities:

 

  • Provide advice to clients on technical, quality, clinical aspects of drug-device combination product development in close collaboration with cross-functional experts from the team.
  • Ensure that content of medical device work-packages and documentation are appropriate and enable CE certification and perform gap analyses for regulatory compliance.
  • Support Notified Body submissions (including NBOp as per MDR Art. 117, clinical investigation, 510(k))
  • Preparation of device-related module-3 sections for MAA and BLA/NDA submissions of drug-device combination products regulated as medicinal products
  • Prepare briefing packages for meetings with Notified Bodies and agencies and conduct such meetings together with the client
  • Management of operational and strategical aspects with CMOs

 

Requirements:

 

  • Ph.D. or master’s degree and at least five years experience in the field including experience in drug development
  • Experience with regulatory filings (technical documentation for CE-certification & STED/application for clinical investigations/pre-RFD/RFP/IDE/De Novo/510(k)/PMA)
  • In depth understanding of medical devices (MDR, IVD, IVDR; 21 CFR Part 820) and QA (ISO 13485)
  • Experience with medical devices and regulatory requirements for all device life-cycle stages and with relevant processes including risk management and usability engineering
  • Team player with strong interpersonal abilities and excellent communication skills in English.

 

We offer:

A professional and friendly working environment located in Munich. Working together with a dedicated small and effective team. We provide an outstanding and more than competitive salary, with a very attractive bonus system tailored to your expertise and our business success.

 

Contact:

If you are interested please send your application documents to Dr. Stefan Blesse, blesse@granzer.biz

 

eCTD Submission Manager

Munich, Germany

 

This position covers the preparation of submissions in the eCTD format in different countries for all types of regulatory activities. It is furthermore concerned with consulting our clients in topics like e-Submission filing strategy, specific software, and document preparation.

 

Tasks & Responsibilities:

 

  • Preparation of submissions in the eCTD format according to the requirements of the relevant authorities (EMA, FDA, National Authorities) for all types of regulatory activities (e.g. MAAs, INDs, NDAs, BLAs, PSUR, amendments, variations, renewals)
  • Re-work and formatting of documents for eCTD-readiness
  • Support maintenance of docuBridge and other e-Submission specific software
  • Support project management of e-Submission projects, including communication with clients and colleagues
  • Consulting for clients concerning submission strategy, electronic submissions and document eCTD-readiness
  • Work in global projects teams

 

Requirements:

 

  • At least 2 years of professional experience in preparation of eCTD dossiers for EU and/or FDA submissions
  • Profound knowledge of technical and content requirements of e-Submissions
  • Sound knowledge of docuBridge software or other eCTD software
  • Very good knowledge of MS Office Package, Adobe Acrobat and DMS

 

We offer:

A professional and friendly working environment located in Munich. Working together with a dedicated small and effective team. We provide an outstanding and more than competitive salary, with a very attractive bonus system tailored to your expertise and our business success.

 

Contact:

If you are interested please send your application documents to Dr. Stefan Blesse, blesse@granzer.biz

 

Regulatory Project Manager

Munich, Germany

 

This position covers project management of regulatory activities from early development, i.e. pre-clinical scientific advice to Project Management of dossier preparation for MAA or BLA/NDA filing.

 

Tasks & Responsibilities:

 

  • Manage EU and FDA Marketing Authorisation Application procedures including:
    1. preparation of Module 1 documents
    2. assignment and management of team resources
    3. co-ordination of Mod 2 & 3
    4. tracking Modules 4 & 5
    5. preparation and track project plans
    6. interaction with Regulatory Agencies on behalf of clients before, during and after approval
    7. management the MAA procedure on behalf of clients
  • Provide regulatory advice to clients
  • Prepare and manage project plans
  • Request Scientific Advice meetings on behalf of clients including preparation of supportive documentation

 

Requirements:

 

  • Master of PhD. in life sciences, medicine or veterinary medicine
  • At least 5 years Project Management and Regulatory Affairs experience, understanding of FDA and ICH regulations and guidelines
  • Competent with Project Management tools and software
  • Excellent communication skills, strategic thinker, solution orientated
  • Ability to work independently and manage multiple tasks simultaneously under time constraints. Flexible with excellent prioritisation skills

 

We offer:

A professional and friendly working environment located in Munich. Working together with a dedicated small and effective team, we provide an outstanding and more than competitive salary, with a very attractive bonus system tailored to your expertise and our business success.

 

Contact:

If you are interested please send your application documents to Dr. Stefan Blesse, blesse@granzer.biz