An Inspiring Environment for your Career
Are you attracted by the idea of solving difficult challenges for leading clients in the life sciences industry? Would you enjoy growing in line with the tasks assigned to you? And do you have the confidence to take responsibility for the results of your work? Do you enjoy working independently as you throw yourself into complex issues, while still appreciating the energizing power of intensive teamwork?
If so, then why not become part of a spirited, ambitious, learning network? Take the next proactive step in your professional career – and welcome on board at MAIN5!
Professional Standards
The corporate culture at MAIN5 is strongly influenced by the professional values and principles that govern our daily work and interactions. One of our key focus areas is on improving the success and efficiency of our leading life science clients in a substantial and durable way. To that end, we are eager to attract, develop, and provide exciting long-term career options for exceptional talents at MAIN5. Continuous development opportunities are therefore an integral component of our customer-oriented and innovative corporate culture.
Creating an Exceptional Place to Work
At MAIN5, the emphasis is on a decentralized way of working, unconstrained by hierarchical structures. From the very first day on the job, MAIN5 gives its specialist consultants the chance to grow in their careers – on a long-term basis. We are eager to attract talented people who see the life sciences sector as their natural home, whether they show potential on the technical or leadership side. As we integrate and develop our decentralized, distributed network of colleagues, partners, and clients, you will be given the support you need by our Managing Partners and Principal Consultants. Your approach is characterized by high levels of integrity and the ability to give constructive criticism, complemented by an analytical mind, secure methodology, and a talent for achieving success with people of all kinds.
MAIN5 GmbH & Co. KGaA is an independent and successful management consulting company headquartered in Frankfurt am Main, Germany. We solve key challenges of our customers sustainably and reliably, each of which is of high relevance in the growing international competition.
Our focus is on the leading companies in the life sciences sector. This is the industry in which we are at home and in which we have sustainable success through the definition, implementation and introduction of forward looking methods, strategies and solutions.
To strengthen our IT Systems & Process division, we are looking for a
Business Consultant – Processes & Systems in Life Science (m/w/d)
Your tasks:
- As a Quality Data Coder, you will translate details from Clinical Development audit reports into standardized quality management codes to enable wide-ranging analysis across all relevant processes of one of the leading global pharmaceutical companies
- You will regularly extract data from audit reports using the QM coding app for upload to the Clinical Data Lake
- You will support the data maintenance process
- You will support data improvement projects
- As a coding reviewer, you will participate in various QM quality events (e.g., discussion of audit
reports/comments, nonconformances, inspection findings) - You will contact auditors / authors of reports to clarify any content ambiguities
Your profile:
- You have successfully completed a degree in the natural sciences or technical field.
- You have a good overview of the core processes in Clinical Development (GcP, GPvP, Regulatory Affairs).
- Very good MS Office skills, especially in Excel
- Good knowledge of the requirements of GxP processes and standards in the pharmaceutical industry In addition to flexibility and ability to work under pressure, you are characterized by a high degree of communication skills
- Your working style is characterized by a "hands on" mentality and you value quality
- Due to the international nature of the company, a very good command of English is required
- A strong sense of responsibility, the ability to work in a team as well as an independent and accurate way of working are your special characteristics
Our offer:
- We offer you individual development, methodical and professional coaching by our experienced
colleagues in a dynamically growing company. - We offer exciting projects and enriching challenges in an interesting market segment with top-class
customers. - You will work in an international environment and belong to a highly motivated and excellent team.
- We offer flexible working hours, home office, state-of-the-art technology for networked collaboration in a virtual organization, performance-based compensation, fairness, openness, freedom for individuality, regular team events, training, and a lot of fun at work.
Your application:
Please send your complete application with cover letter, résumé, and – if appropriate – relevant references and certificates to Gero Neidlinger, E-mail: recruiting@main5.de.
PDF downloadMAIN5 GmbH & Co. KGaA is an independent and successful management consulting company headquartered in Frankfurt am Main, Germany. We solve key challenges of our customers sustainably and reliably, each of which is of high relevance in the growing international competition.
Our focus is on the leading companies in the life sciences sector. This is the industry in which we are at home and in which we have sustainable success through the definition, implementation and introduction of forward looking methods, strategies and solutions.
To strengthen our IT Systems & Process division, we are looking for a
Business Consultant – Clinical R&D (m/f/d)
Your tasks:
- As a Business Consultant, as part of an account team, you will actively work and advise on the analysis and development of new regulatory business processes in Clinical R&D.
- You will organize and conduct workshops with the people involved and actively take on implementation, preparation, and follow-up tasks.
- You will work exclusively for the research-based life sciences industry and get to know customer requirements in the context of IT-supported business processes.
- Through "Training on the Job" you will acquire extensive knowledge of the industry and its specific requirements in the various areas.
- You will take responsibility for your tasks at an early stage and generate independently results, document and present them in direct dialogue with the project team and our customers.
Your profile:
- You have successfully completed a degree in the natural sciences or technology.
- You have already gained initial experience in the areas of Clinical R&D or Quality Management.
- You have experience in the management of clinical trials and data and are familiar with eTMF and CDMS.
- As an experienced consultant, you have already gained experience in leading teams as well as in customer service and project acquisition.
- You enjoy new challenging tasks, in a complex environment, like to travel and have very good communication and presentation skills in English and possibly in German.
Our offer:
- We offer you individual development, methodical and professional coaching by our experienced colleagues in a dynamically growing company.
- We offer exciting projects and enriching challenges in an interesting market segment with top-class customers.
- You will work in an international environment and belong to a highly motivated and excellent team.
- We offer flexible working hours, home office, state-of-the-art technology for networked collaboration in a virtual organization, performance-based compensation, fairness, openness, freedom for individuality, regular team events, training, and a lot of fun at work.
Your application:
Please send your complete application with cover letter, résumé, and – if appropriate – relevant references and certificates to Tore Bergsteiner, E-mail: recruiting@main5.de.
MAIN5 GmbH & Co. KGaA is an independent and successful management consulting company headquartered in Frankfurt am Main, Germany. We solve key challenges of our customers sustainably and reliably, each of which is of high relevance in the growing international competition.
Our focus is on the leading companies in the life sciences sector. This is the industry in which we are at home and in which we have sustainable success through the definition, implementation and introduction of forward looking methods, strategies and solutions.
To strengthen our IT Systems & Process division, we are looking for a
Business Consultant – Regulatory Affairs (m/f/d)
Your tasks:
- As a Business Consultant, as part of an account team, you will actively work and advise on the analysis and development of new regulatory business processes in R&D and Regulatory Affairs.
- You will organize and conduct workshops with the people involved and actively take on implementation, preparation, and follow-up tasks.
- You will work exclusively for the research-based life sciences industry and get to know customer requirements in the context of IT-supported business processes.
- Through "Training on the Job" you will acquire extensive knowledge of the industry and its specific requirements in the various areas.
- You will take responsibility for your tasks at an early stage and generate independently results, document and present them in direct dialogue with the project team and our customers.
Your profile:
- You have successfully completed a degree in the natural sciences or technology.
- You have already gained initial experience in the areas of Regualtory Affairs, R&D or Quality Management.
- You have experience in the management of content and data submissions and are familiar with RIM, IDMP/XEVMPD.
- As an experienced consultant, you have already gained experience in leading teams as well as in customer service and project acquisition.
- You enjoy new challenging tasks, in a complex environment, like to travel and have very good communication and presentation skills in English and possibly in German.
Our offer:
- We offer you individual development, methodical and professional coaching by our experienced colleagues in a dynamically growing company.
- We offer exciting projects and enriching challenges in an interesting market segment with top-class customers.
- You will work in an international environment and belong to a highly motivated and excellent team.
- We offer flexible working hours, home office, state-of-the-art technology for networked collaboration in a virtual organization, performance-based compensation, fairness, openness, freedom for individuality, regular team events, training, and a lot of fun at work.
Your application:
Please send your complete application with cover letter, résumé, and – if appropriate – relevant references and certificates to Tore Bergsteiner, E-mail: recruiting@main5.de.
MAIN5 GmbH & Co. KGaA is an independent and successful management consulting company headquartered in Frankfurt am Main, Germany. We solve key challenges of our customers sustainably and reliably, each of which is of high relevance in the growing international competition.
Our focus is on the leading companies in the life sciences sector. This is the industry in which we are at home and in which we have sustainable success through the definition, implementation and introduction of forward looking methods, strategies and solutions.
To strengthen our IT Systems & Process division, we are looking for a
(Senior) Consultant – Computer Systems Validation (m/f/d)
Your tasks:
- Ideally, you have professional experience in the field of process and system validation in clinical R&D, regulatory affairs and/or quality in the pharmaceutical industry
- They already have convincing project successes in the validation of regulatory processes and corresponding system solutions.
- You will master both the conception and implementation of validation measures with a focus on Research & Development (R&D) and related regulatory-relevant business solutions.
- They moderate, document and present results in direct dialogue with our customers.
- You will take responsibility for your tasks and manage them independently to the agreed results.
Your profile:
- You have successfully completed a degree in the technical or scientific field, e.B biology, chemistry, pharmacy, bioinformatics, computer science or similar with a bachelor's, master’s, or PhD.
- You have gained experience in computer system validation (CSV) in several projects.
- You have experience in the development of validation plans and their implementation and know how to bring about and implement viable solutions in an environment of competing interests.
- Ideally, you have a good knowledge of the processes and systems within the life sciences industry with a focus on R&D, regulatory affairs and/or QA
- You have sound practical experience in the application of relevant regulations and know how to derive practicable measures according to GAMP5 from this.
Our offer:
- We offer you individual development, methodical and professional coaching by our experienced colleagues in a dynamically growing company.
- We offer exciting projects and enriching challenges in an interesting market segment with top-class customers.
- You will work in an international environment and belong to a highly motivated and excellent team.
- We offer flexible working hours, home office, state-of-the-art technology for networked collaboration in a virtual organization, performance-based compensation, fairness, openness, freedom for individuality, regular team events, training, and a lot of fun at work.
Your application:
Please send your complete application with cover letter, résumé, and – if appropriate – relevant references and certificates to Tore Bergsteiner, E-mail: recruiting@main5.de.