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Consultant / Senior Consultant – Regulatory - remote (m/w/d)

Remote: 
Full Remote
Contract: 
Freelance
Experience: 
Senior (5-10 years)
Work from: 
Germany

Offer summary

Qualifications:

Bachelor's degree in related field or higher., Up to 5 years of experience in Pharmaceutical Industry., Basic understanding of regulatory processes and data., Competence in data management and analytics..

Key responsabilities:

  • Work on RIMS system implementations.
  • Collaborate with consultants and clients on projects.
MAIN5 logo
MAIN5 Scaleup http://www.main5.de/
51 - 200 Employees
About MAIN5
At MAIN5, we redefine consulting with a dynamic and forward-thinking approach, positioning ourselves as leaders in the ever-evolving landscape of the Life Sience Industry. With over 60 dedicated professionals, we are committed to driving innovation and digital transformation for our clients. Our Core Values: Innovation, Expertise, and Excellence Innovation: In a world shaped by rapid advancements, MAIN5 stands at the forefront of industry trends. We embrace innovation as a guiding principle, ensuring our clients stay ahead in the competitive life science sector. Our commitment to cutting-edge technologies is unwavering, making us your strategic partner in navigating the digital age. Expertise: With a team of seasoned professionals, MAIN5 brings unparalleled expertise to the table. Our consultants are adept in Regulatory Affairs, Quality, Safety, Clinical, and other critical areas along the R&D value chain. We provide tailored solutions that align with your unique challenges, leveraging our deep industry knowledge to drive success. Excellence: At MAIN5, excellence is not just a goal; it's our standard. We pride ourselves on delivering tangible and sustainable results for our clients. Our track record showcasing a history of successful projects in Change Management, Business Process Management, System implementations, eLearning, Quality & Compliance that have empowered organizations to thrive in the face of complexity.
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Job description

Your mission
  • Work with other MAIN5 consultants in projects like RIMS system implementations, Health Authority requirements like IDMP, regulatory data management, data quality. 
  • Take responsibility of deliverables in projects, collaborate with other MAIN5 consultants and customers in projects to deliver in line with customer expectations and needs. 
  • Enhance your expertise and personal development by collaborating with MAIN5 experts on project-related work and engaging in internal learning and knowledge-sharing initiatives. 
  • Advocate MAIN5's values and methods of work. 
  • Foster a culture of knowledge sharing and learning from each other. 
  • Join the MAIN5 family to become part of a dynamic community.
Your profile
  • Bachelor’s degree or higher in Biology, Chemistry, Biochemistry, Pharmacy, Biomedical Science, Health Science, Computer Science or related field. Alternatively, applicants with similar educational backgrounds or certifications and a minimum of relevant practical work experience are also welcome to apply.  
  • You are just starting your professional career or have up to 5 years of experience in the Pharmaceutical Industry in the area of Regulatory Operations and Regulatory Information Management. 
  • You are passionate when it comes to driving digital transformation in Life Sciences, enabling data driven regulatory submissions, and automating processes. 
  • You have a basic understanding of regulatory processes and data or are interested to learn these to support business functions on regulatory projects and initiatives to enhance daily operations and comply with Health Authority requirements. 
  • You are affine in data management, including Data Governance and Master Data Management and would like to deepen your expertise in these areas, ideally with first practical experience. 
  • You have an affinity to understand business requirements and technology which enables you to translate between both effectively. 
  • You have strong analytical and problem-solving skills, with attention to detail and the bigger picture. 
  • As a communicative team player, you can work effectively in a collaborative environment
Why us?
  • We offer exciting tasks and projects in an interesting market segment with high-caliber clients & topics
  • You will work in an international environment and be part of a highly motivated and excellent team
  • You will receive an intensive induction and be integrated into your team, which is characterized by its helpfulness and communication at eye level
  • You will benefit from flexible working hours in a home office in a dynamically growing company with above-average earning potential
  • We offer a secure job with long-term prospects for personal development
  • We also offer a wide range of internal and external training opportunities
  • Other benefits include working from home, a pleasant and creative working atmosphere and company events
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About us

MAIN5 GmbH & Co. KGaA is an independent, international and successful management consulting company headquartered in Frankfurt am Main. We provide sustainable and reliable solutions for our clients' key issues in the field of digital transformation, each of which is highly relevant in the face of growing international competition. Our focus is on leading international companies in the life sciences sector. This is the sector in which we are at home and in which we have a track record of sustainable success through the design and implementation of forward-looking methods, strategies and solutions.


Required profile

Experience

Level of experience: Senior (5-10 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

Regulatory AffairsData GovernanceRegulatory ComplianceData ManagementMaster Data ManagementDigital TransformationLife SciencesIdms

Other Skills

  • Problem Solving
  • Analytical Skills
  • Detail Oriented
  • Teamwork
  • Communication
Are you interested?

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