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Our people help shape the future of life sciences

Have a look at our vacancies

Our ambition is to enhance the quality and safety of medicines and help shorten the time to market for drugs and medical devices that improve the quality of life. Working alongside smart and driven colleagues, you can make a lasting impact on our customers, the industry and patient health around the world. Within a consultancy environment, knowledge and experience are important, but we also welcome people who are just embarking on their career. We provide a culture where being result-driven, enthusiasm and being passionate about your job are equally important.

More about Xendo

  • A rapidly developing organisation with ample career opportunities
  • Working on various projects offers the chance to gain substantial experience
  • Xendo invests extensively in training and education
  • Based in 4 countries, our professionals ensure worldwide delivery of services

Meet some of our extraordinary people

Angella Angiji

As a Graduate in Molecular Life Sciences, Angie is fascinated by science in general and its importance and contribution to human health. She has a proven track record in science and strong communication skills, she is also comfortable with new environments, tasks, and working with many different types of individuals; making her an ideal candidate for our Young Talent program. Currently, she is active in our Adverse Event Managment team while increasing her expertise with a Masters in Pharmacovigilance.

Joost Havers

Joost has a background in Mechanical Engineering and has been involved in data management and validation on a personal level as well. Following an internship at Xendo he started as a Quality Engineer in which function he developed several services like asset management and computer systems validation and is now one of our longer-serving employees.

Currently working as managing consultant, he has built up his own team surrounding these services and is successfully executing a wide variety of projects and is also a board member of the local ISPE GAMP-COP.

Liesbeth Hof

With a background in medical biology, Liesbeth worked in big pharma for over 10 years. During these years she was actively involved in the development and execution of global regulatory strategies across therapeutic areas. She truly enjoys working as a consultant as it allows her to bring in her regulatory knowledge and wide range of experiences towards Xendo and towards the clients. It is a pleasure for her to work with the clients, being in direct contact with them and contributing to their product life cycles whether it involves hands on work or strategic advice.

Marc Stegeman

I am Marc Stegeman and I work as a Principal Consultant and Black Belt with Xendo. I very much enjoy my work as a consultant. It brings together all my experience gained as a specialist and manager in QA, regulatory, Lean Six Sigma and manufacturing. Most of this type of work I did in previous jobs, at one company, at one site. Today, this context has been expanded while doing this work at different places, at different customers with different interests and moods, but in one week.

Camilo Molina

Camilo Molina started his career at Merck Sharp & Dohme in Colombia, where he supported the regulatory submissions to the local authority and also managed data of clinical study visits. He also worked in R&D developing new cosmetic formulations. To pursue new challenges and to experience different cultures, he came to Germany and decided to stay. At Xendo he got engaged in new IT solutions within regulatory intelligence and works as a RA Project Manager. Additionally, he is a part of the Xendo eCTD core team helping clients creating sequences.

Xiaoxi Zhuh

Xiaoxi brings her passion of science into the regulatory affairs field and uses her expertise in analytics to help our clients to develop their biological and biosimilar products. With the believe that science is not limited to the lab, she brings in her research experience to scientific advice procedures, IMPD and CMC writing.

During her life, she moved from China to the USA and Germany and Xiaoxis understanding of multi-cultural backgrounds explains her success in leading international projects. During her time at Xendo, Xiaoxi expanded her regulatory knowhow by certified project management skills. She especially enjoys working in our international and open-minded company.

Vacancies

#(Senior) Consultant – Regulatory CMC (Berlin office)

Xendo's German office in Berlin is looking for a new colleague to join the RA CMC team. Specifically, we're looking for someone who enjoys engaging in different projects in the pharmaceutical industry and to assist our clients in fulfilling their business needs. If you have experience in a this (or a similar) field, are open minded, result- and solution-oriented and possess good interpersonal skills, please contact us. 

ABOUT US

Xendo is a leading consultancy and project management organisation in the fields of (bio) pharmaceutical products, medical devices, and healthcare. Thanks to our multi-disciplinary, knowledge-driven approach, Xendo can deliver a broad palette of services to the life sciences industry, applying the right colour to projects we participate in. For over 25 years, we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, established multinational companies and organisations.

Over 240 experienced and highly educated professionals offer their expertise ranging from strategic advice and project management to auditing, operational support, and training; providing a full-colour spectrum. They do so from our headquarters in the Netherlands or offices in Germany and Sweden.

RESPONSIBILITIES

  • Regulatory CMC writing of CTD-Modules 2.3 & 3
  • Providing regulatory advice in regards to pre- and post-marketing issues to clients
  • Preparation and submission of applications for marketing authorisations and variations including handling of deficiency letters for human medicinal products
  • Communication with regulatory authorities
  • Preparation of briefing documents for scientific advice procedures
  • Managing projects and project teams
  • Maintaining and building client relationships

PROFILE

  • You, ideally hold a D. in Chemistry, Biochemistry or Pharmacy.
  • You have proven experience in the pharmaceutical industry in roles such as Product Development, Manufacturing, Quality or Regulatory Affairs.
  • You have an excellent understanding of the pharmaceutical product lifecycle.
  • You have extensive experience in preparing documentation for regulatory authorities.
  • You are able to maintain high quality, accuracy, and consistency in your work and deliver on your commitments.
  • You are willing to undertake business travels to clients and other Xendo sites.
  • You have a positive attitude and are able to work well within a
  • You are able to work independently with less supervision, take initiative and make decisions based on company guidelines.
  • You are able to work on multiple projects, prioritize and meet project deadlines.
  • You are an excellent communicator and have the ability to work with all levels of the company.
  • You can transfer knowledge to others and teach them abilities based on a coherent educational programme.
  • You have excellent German and English skills.

WE OFFER

  • A diversity of interesting projects regarding different products with different clients
  • A flexible, dynamic and pleasant work atmosphere
  • Opportunities for learning and further development
  • Good terms of employment

If you are interested in this position, please send your complete application to Vivian Maumo-Ney: In case of any questions, please do not hesitate to get in touch with us. We are looking forward to your application!

medical science safety

#Managing Consultant QPPV & Medical Safety Science

Are you interested in an independent and responsible position in a growing organisation with the opportunity to develop yourself? Then this might be your chance! Xendo is looking for an experienced pharmacovigilance professional with managerial experience that wants to further build the QPPV & Medical Safety Science team combined with the option to carry out own assignments for clients as well.

COMPANY

Xendo is a consultancy and project management organisation in the (bio)pharmaceutical, medical devices and healthcare fields. Thanks to our multi-disciplinary, knowledge driven approach, Xendo can deliver a broad palette of services to the life sciences industry, applying the right colour to projects that we participate in. For over 25 years, we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, most established multinational companies and organisations.

The pharmacovigilance division became part of Xendo in 2013 and the work is performed on a global level. You are located in our office in Leiden where the majority of the QPPV & Medical Safety Science team is based, with the option to work from home as well.

TEAM

The QPPV & Medical Safety Science Team consists of a team of experts with very broad experience in analyzing and evaluating data and writing of required periodic reports. Next to the fulfillment of QPPV roles fro MAHs, activities in this team have a main focus on report writing (DSURs, PSURs/PBRERs, (development) RMPs), risk and signal management, global literature assessment and providing consultancy or training for clients in the aforementioned areas, both in pre-approval and post-approval phase. The Managing Consultant reports directly to the Director Pharmacovigilance and is part of the PV management team, where you are a key player in the determining the strategy for the PV division and its services.

WHO WE ARE LOOKING FOR

This role is a challenging position for someone with extensive experience in leadership and pharmacovigilance.

YOUR ROLE

The Managing Consultant leads the team of consultants and coordinates the planning of projects and reviews workload for all direct reports. Your line management responsibilities include performance appraisals, training, professional development, hiring and coaching. You will contribute to the growth of Xendo by building relationships with new and existing clients, identifying opportunities with clients and develop, together with your team of Consultants, new services the future. You provide oversight and guidance on organisational goals and company objectives. In addition to line management responsibilities, you also carry out your own assignments.


YOUR PROFILE

  • You hold an academic degree in life science, medical or paramedical field;
  • Extensive knowledge in report writing;
  • You have worked in a wide variety of roles for several companies & experience as EU QPPV;
  • Demonstrated leadership and managerial skills, leads by example;
  • Excellent communication skills (oral and written) in English;
  • Analytical skills, proactive, decisive, listening skills, flexible and negotiation skills;
  • Enthusiastic & self-starter.

INFORMATION

Please contact Paul Zantingh, Talent Acquisition Manager at +31 71 524 40 00 or by e-mail for additional information about job specifics.

OUR OFFER

  • A dynamic and varied position in a fast-growing and professional organisation;
  • Good terms of employment;
  • Consultancy, Project Management, and Interim Management for a variety of clients;
  • Diverse projects that span a wide range of topics and phases of facility management in life science;
  • An extensive development programme for hard and soft skills.

## SENIOR PROCESS AND MECHANICAL ENGINEER

The Engineering & Technical Support Division is strengthening its process engineering team with a process and mechanical engineer. If you are an experienced professional with a proven track record in process equipment and/or mechanical engineering, then this might be your chance!

Company

Xendo is an engineering, consultancy and project management organisation in the (bio)pharmaceutical, medical devices and healthcare fields, meaning that your clients are operating in the life science sector. Thanks to our multi-disciplinary, knowledge-driven approach, Xendo can deliver a broad palette of services to the life sciences industry, applying the right colour to projects that we participate in. For over 25 years, we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, most established multinational companies and organisations.

Team

(Bio) Process Engineering, reporting to the Managing Consultant.

Who we are looking for

We want people who value continuous learning and who always look for ways to improve further. It is important to us that you can inspire and motivate others by giving regular and constructive feedback for both your own performance and on the performance of others. We promote a working environment based on cooperation and respect and encourage an atmosphere that fosters creativity and innovation. This role is a challenging position for someone with both technical skills and demonstrated consulting skills. We enable you to develop these skills while delivering solutions to the challenges of our clients.

The successful candidate for this position will be able to take a project from the conceptual stage through to completion, taking into account budgeting and operational considerations.

The position

Based on your (bio)process engineering experience you develop conceptual process designs for manufacturing facilities for biopharmaceutical products. You can size and specify both upstream and downstream process equipment to enable the safe and GMP-compliant production of virus vaccines, monoclonal antibodies, therapeutic proteins etc.

You support the procurement of the process systems from a technical perspective and supervise the construction of the equipment, both at vendor premises as well as the manufacturing site. You manage, support, or execute commissioning and qualification of the systems. These activities generally take place in a Xendo team either at the Xendo office or at the client’s facilities.

Your Profile

  • Bachelor/Master’s degree in process/mechanical engineering;
  • Engineering Qualification in Process Technology or Mechanical Engineering – essential;
  • Good communication skills and interpersonal skills;
  • Client-oriented, dedicated, flexible, proven project management skills with helicopter view and able to quickly switch between different assignments;
  • Good analytical-, listening-, and negotiation skills;
  • Proactive, decisive;
  • Independent, structured, and result-driven attitude;
  • Ambitious and enthusiastic relation builder with a quality-driven mindset;
  • Strong organization and problem-solving skills;
  • Excellent proficiency in the English language;
  • Proficient in using MS Office tools;
  • Relevant work experience, experience in pharma/ biotech industry is an advantage;
  • Experience with equipment engineering is an advantage;
  • Driving licence

Information

Please contact Paul Zantingh, Talent Acquisition Manager at +31 71 524 40 00 or by e-mail for additional information on job specifics.

Our offer

  • A dynamic and varied position in a fast-growing and professional company;
  • Good terms of employment;
  • Consultancy, Project and Interim Management at multiple clients;
  • A wide range of projects spanning different phases in facility life science
  • An extended development programme on hard and soft skills.

Applying

If you are interested in this position, we encourage you to send your motivation and CV to us:

Xendo B.V.
Att.: HR department
P.O. box 255
2300 AG Leiden or email to:

#Managing Consultant Quality Assurance

Will you seize the opportunity to work with and lead an established team that has a proven track record in the area of quality assurance? Are you looking for an intellectually challenging job with a lot of responsibility, independence and career possibilities in the field of quality assurance? Then this might be your chance!

The division Compliance & Validation is searching for a Managing Consultant.  If you are a leader and have a passion for serving others, then we would like to hear from you.

Company

Xendo is a consultancy and project management organisation in the (bio)pharmaceutical, medical devices and healthcare fields. Thanks to our multi-disciplinary, knowledge driven approach, Xendo can deliver a broad palette of services to the life sciences industry, applying the right colour to projects that we participate in. For over 25 years, we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, most established multinational companies and organisations.

Team

Quality Assurance, reporting to the Director Compliance & Validation

Who we are looking for


Those who make the difference – in the way they act, collaborate and lead. As a Managing Consultant you will have the opportunity to share your extended knowledge in the field of quality assurance with Xendo’s clients and to closely collaborate with colleagues across divisions. Addressing new challenges and finding innovative solutions is your prerogative.

The position

The Managing Consultant leads the Quality Assurance team, coordinates the planning of projects, and reviews workload for all direct reports (Young Talents and (Associate, Senior) Consultants). Your line management responsibilities include performance appraisals, time sheet approval, training, professional development, hiring, and coaching. You will contribute to the growth of Xendo by building relationships with new and existing clients, identifying opportunities with clients, and developing, together with your team of consultants, new services for the future.

You provide oversight and guidance on organisational goals and company objectives. In addition to line management responsibilities, you also carry out your own assignments within the scope of the Quality Assurance team.

Who we are looking for

This role is a challenging position for someone with extensive experience and a proven track record in Quality Assurance. The ideal candidate also demonstrates management and consulting competencies such as people and change management, programme management, business process design, transformation and employee processes.

Your Profile

  • Bachelor / Master’s degree in life sciences;
  • Demonstrated experience in all QA aspects and as a QP;
  • Thorough knowledge of GMP;
  • Experience in industrial pharma environment (preferably from development to commercialisation);
  • Good communication skills and interpersonal skills;
  • Client-oriented;
  • Client-oriented, dedicated, flexible, proven project management skills with a helicopter-view, and ability to quickly switch between different assignments;
  • Analytical skills, proactive, decisive, listening skills, flexibility, and negotiation skills;
  • Managerial experience is a plus;
  • Ambitious and enthusiastic relationship builder with a quality-driven mindset;
  • Excellent proficiency in the English and Dutch languages.

Information


Please contact Paul Zantingh, Talent Acquisition Manager at +31 71 524 40 00 or by e-mail for additional information on job specifics.


OUR OFFER

  • A dynamic and varied position in a fast-growing and professional organisation;
  • Good terms of employment;
  • Consultancy, Project Management, and Interim Management for a variety of clients;
  • Diverse projects that span a wide range of topics and phases of facility management in life science:
  • An extensive development programme for hard and soft skills.

APPLYING

If you are interested in this position, we encourage you to send your motivation and CV to us:

Xendo B.V.

Att.: HR department

P.O. box 255

2300 AG Leiden or email to:

regulatory affairs

#(Senior) Consultant Regulatory Affairs Labelling (m/f) - Berlin

(Senior) Consultant – Regulatory Affairs

About Us

Xendo is a leading consultancy and project management organisation in the fields of (bio) pharmaceutical products, medical devices, and healthcare. Thanks to our multi-disciplinary, knowledge-driven approach, Xendo can deliver a broad palette of services to the life sciences industry, applying the right colour to projects we participate in. For over 25 years, we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, established multinational companies and organisations.

Over 240 experienced and highly educated professionals offer their expertise ranging from strategic advice and project management to auditing, operational support, and training; providing a full-colour spectrum. They do so from our headquarters in the Netherlands or offices in Germany and Sweden.

Responsibilities

  • Regulatory and medical writing of CTD-Modules 2.5, 2.7, 5
  • Preparation and submission of applications for marketing authorisations and variations including handling of deficiency letters for human medicinal products
  • Providing regulatory advice in regards to pre- and post-marketing issues to clients
  • Review of promotional materials (Informationsbeautragte), §74a AMG
  • Communication with regulatory authorities
  • Preparation of briefing documents for scientific advice procedures
  • Preparation and translation of product information texts including linguistic review procedures
  • Preparation and submission of variations for medicinal products
  • Project Management

Profile

  • You, ideally hold a Ph.D. in Pharmacy, Biology, Veterinary or Human Medicine.
  • You have proven experience in Regulatory Affairs or Medical Writing.
  • You are good in writing scientific and technical texts.
  • You are ready to take over the role of Information Officer for clients.
  • You are able to maintain high quality, accuracy and consistency in your work and deliver on your commitments.
  • You have a positive attitude and are able to work well within a
  • You are able to work independently with less supervision, take initiative and make decisions based on company guidelines.
  • You are able to work on multiple projects, prioritize and meet project deadlines.
  • You are an excellent communicator and have the ability to work with all levels of the company.
  • You can transfer knowledge to others and teach them abilities based on a coherent educational programme.
  • You are well organized and pay attention to detail.
  • You have outstanding German and English skills.

We Offer

  • A diversity of interesting projects regarding different products with different clients
  • A flexible, dynamic and pleasant work atmosphere
  • Opportunities for learning and further development
  • Good terms of employment

If you are interested in this position, please send your complete application to Vivian Maumo-Ney: In case of any questions, please do not hesitate to get in touch with us. We are looking forward to your application!

#(Associate) consultant Regulatory Affairs

Are you a starting RA professional and looking for career growth?

As a result of the continuous growth of our company and the Regulatory Affairs Division we are looking for a starting professional who like to expand his/her experience in Regulatory Affairs by working in a challenging role as an (associate) consultant RA.


The company


For 25 years Xendo is a leading consultancy organization for the (bio) pharmaceutical industry, medical devices and Life Sciences industry, based near the Bio Science Park in Leiden. In recent years Xendo successfully delivered projects for more than 400 clients. Xendo has an excellent international reputation as a consultancy organization. Most of the work is performed in the Netherlands, Germany and the Nordic Countries, but also on an EU and Worldwide level. Our expertise lies in Regulatory Affairs, Pharmacovigilance, OPEX/Quality Management, Engineering, Qualification & Validation, Product Development and E-Compliance & Data Management.

The environment

Being a consultant you will have the opportunity to work in a wide variety of projects and companies. Assignments may cover all aspects of regulatory affairs ranging from pre-approval and scientific advice meetings to regulatory maintenance, from CMC to regulatory project management and from work on small molecules to high-tech (biological) products.
Depending on your expertise, experience and interest you will be assigned to customers looking for hands-on support and/or requiring advice on regulatory strategic issues. The duration and size of the projects can vary from months to years, from 5 days a week to a couple of hours a month and from working at your own home to the office of the customer. Depending of the project you work within a team or independent, coached by a senior consultant


Your profile


You are an entrepreneur, able to think and act at a scientific level, who is able to quickly adjust to different working environments. A high degree of flexibility in working with different companies and people is required. An open eye for the needs of your customers and the ability to adjust to these needs is essential. At least 1-3 years of experience in regulatory affairs within the pharmaceutical industry or government agency is a requirement.
With these experience you are curious about new opportunities for yourself, the client and Xendo, a self-starter and quick learner with excellent communication skills. Your Dutch and English are fluent.
You aim for a consistent high quality in your work and deliver on your commitments. You are able to manage timelines and prioritize your work. You are well aware of the regulatory legislation, guidelines and directives and are able to assess the impact of changes in this area on the products or portfolio of your customers.
If this profile fits to you and the above environment interest you we encourage you to apply.

Our Offer

We invest in our employees. Such as level-raising courses, subject-specific training courses or courses aimed at personal development. That is good for you and also good for us, when you broaden your knowledge and expertise. There are chances to grow to a higher position means in the first place that you get more responsibility, but your job content also can sometimes change completely. We certainly encourage you to take advantage of all the opportunities you get and show initiative in this.

Information


For more information about the content of the job, you can contact our HR department at 071-524 4000

#Consultant Medical Devices

We are looking for people who like to share their extensive knowledge to support our customers in the field of medical devices. You will be part of the medical device team preparing solutions, efficient and target oriented, and taking the lead and responsibility in the execution of our projects. You like to combine communication skills with in-depth medical device knowledge to ensure that any innovative solution is transferred to our customers in the most efficient manner. Working locations vary between Xendo and customer offices.

Company

Xendo is a consultancy and project management organisation in the (bio) pharmaceutical and medical devices and healthcare fields, meaning that your clients are operating in the life science sector. Thanks to our multi-disciplinary, knowledge driven approach, Xendo can deliver a broad palette of services to the life sciences industry, applying the right colour to projects that we participate in. For over 25 years, we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, established multinational companies and organisations.

 

Team

Medical Devices, reporting to the managing consultant.

 

Who we are looking for

Those who dare to make the difference – in the way they act, collaborate and lead. As a Consultant you will have the opportunity to share your extended knowledge in the field of Medical Devices with Xendo’s clients and closely collaborate with colleagues across divisions. Addressing new challenges and finding innovative solutions is your prerogative. Mostly working on-site, at the client's premises, you welcome independent responsibility for your projects. 

 

The position

You will work independently or jointly in a team for our customers with activities in the medical device industry. The scope of your consult, advice and project work will encompass (worldwide) product registration, defining regulatory strategies, dossier writing or review, participation and/or arrange meetings with our clients and/or notified bodies and governmental authorities. In addition, services rendered as a consultant can include; interim management, quality assurance, regulatory & clinical affairs or other relevant fields. As a consultant, you will continuously anticipate on future and current relevant developments for our clients. You will be responsible for organising and coordinating projects independently with adequate communication and in full transparency to our clients.

 

Your Profile

  • Bachelor’s or Master’s degree in (para)medical sciences;
  • Relevant knowledge and experience (at least 2 years) in the medical device industry preferably in multiple environments
  • Project Management skills;
  • Customer oriented, passionate and able to effectively switch between different assignments;
  • Ambitious and enthusiastic relation builder with a quality driven mind-set;
  • Excellent proficiency in English and Dutch language

 

Information

Please contact Jan Bart Hak, Managing Consultant at +31 71 524 40 00 or by e-mail for additional information on job specifics.

OUR OFFER

  • A dynamic and varied position in a fast-growing and professional company;
  • Good terms of employment;
  • Consultancy, Project and Interim Management at multiple clients.
  • Our projects span a wide range and in different phases in facility life science; an extended development programme on hard and soft skills.

Applying

If you are interested in this position, we encourage you to send your motivation and CV to us:

Xendo B.V.

Att.: HR department

P.O. box 255

2300 AG Leiden or email to:

#Principal Consultant Pharmacovigilance (Business Development)

Purpose:

The Principal Consultant Business Development strengthens Xendo’s market position, reputation and achieves further growth of the business, both for extending of our existing services as well as for product development. Together with the Division Director Pharmacovigilance the Principal Consultant Business Development Pharmacovigilance defines long-term pharmacovigilance strategic goals, builds key customer relationships, identifies business opportunities, negotiates and closes business deals, maintains extensive knowledge of current and upcoming market conditions and business critical regulatory intelligence.

Positioning:

The Principal Consultant Business Development reports to the Division Director Pharmacovigilance and is part of the PV management team.

Responsibility:

The Principal Consultant works with the Division Director Pharmacovigilance and Pharmacovigilance (Managing and Senior) Consultants, and cross-functional with other Division Directors and Country Managing Directors to increase sales opportunities and thereby maximize reputation and revenue for Xendo. To achieve this, in addition to consolidating and extending our customer base, new potential customers need to be identified and targeted, Xendo’s palette of opportunities proposed to them, to ultimately converted these into packages taken up by these clients, and continue to grow business in the future.
The incumbent will also help manage existing clients and ensure they stay satisfied. The Principal Consultant Business Development will call on clients, often being required to make presentations on solutions and services that meet or predict their clients’ future needs.

Job Description

The primary responsibility of the Principal Consultant Business Development Pharmacovigilance is to entice new clients and bring in new assignments and pharmacovigilance services by networking, calling, social media usage, active participation in congresses and events or other means of generating visibility and interest from potential clients and actively expand current relationships and partnerships. You will operate as the lead point of contact for any and all matters for specific pharmacovigilance accounts and will maintain and build strong, long-lasting customer relationships. You will lead and take ownership for RFP processes from request to contract implementation.

Internal Interaction

The Principal Consultant Business Development Pharmacovigilance works Division Directors, COO, Country Managing Directors, Principal Consultants, Managing Consultants, Senior Consultants and Business Support.

New Business Development activities

  • Prospect for potential new Pharmacovigilance clients exploring opportunities and turn this into increased and profitable business.
  • Identify potential clients, and the decision makers within the client organization.
  • Set up meetings between client decision makers and Xendo senior management.
  • Plan approaches and pitches. Develop proposals that speaks to the client’s needs, concerns, and objectives.
  • Handle objections by clarifying, emphasizing agreements and working through differences to a positive conclusion. Use a variety of styles to persuade or negotiate appropriately.
  • Present an image based on Xendo’s unique selling points that mirrors that of the client.
  • Attend industry functions, such as association events and conferences, and provide feedback and information on market and creative trends.
  • Present to and consult with senior management on business trends or trendsetter ideas with a view to fine-tune existing services and products or developing new services and products based on market demand.
  • Identify opportunities for campaigns and services that will lead to an increase in sales.
  • Call as appropriate within your market or geographic area to ensure a robust pipeline of opportunities. Meet potential clients by growing, maintaining, and leveraging your network.
  • Using knowledge of the market and competitors, identify and develop Xendo’s unique selling propositions and differentiators.

Client Retention

  • Present new (cross divisional) products and services and enhance existing relationships.
  • Work with internal colleagues to meet customer needs.
  • Arrange and participate in internal and external client debriefs.
  • Business Development Planning
  • Management and Research
  • Ensure that data is accurately entered and managed within the Xendo’s CRM system.
  • Forecast sales targets in collaboration with Division Director Pharmacovigilance and ensure these are met.
  • Track and record activity on accounts and leads to close deals to meet these targets.
  • Develop a thorough understanding of the people and capabilities cross divisions.

Education and requirements

  • Bachelor or Master’s Degree with at least 7-10 years of experience
  • Preferably 5 years of sales or business development experience
  • Proven pharmacovigilance expertise and comprehensive understanding of applicable international requirements in this field
  • Prior hands on experience in pharmaceutical industry
  • Experience with alliances, partnering or licensing is considered a plus

Other Skills and Qualifications

Networking, Persuasion, Public Speaking, Research, Writing, Closing Skills, Motivation for Sales, Prospecting Skills, Sales Planning, Identification of Customer Needs and Challenges, Market Knowledge.

#Auditor Pharmacovigilance

As an experienced (Senior) pharmacovigilance auditor you will be responsible for managing and executing the Xendo pharmacovigilance (PV) audit programme you will be conducting audits across the entire range of PV relevant activities, with primary responsibility for planning and participating in global PV audits. The breadth of audits performed include the end to end PV system including PV system key elements, PV QMS , service providers, internal and affiliate audits on behalf of Xendo clients.

Company

Xendo is a consultancy and project management organisation in the (bio) pharmaceutical, medical devices and healthcare fields. Our clients are predominantly operating in the life science sector. Thanks to our multi-disciplinary, knowledge driven approach, Xendo delivers a broad palette of services to the life sciences industry, applying the right colour to projects that we participate in. For over 25 years, we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, established multinational companies and organisations. Our Pharmacovigilance Division that is a legacy of the Vigilex Company became part of Xendo in 2015 The work in this division is performed on a national, EU and Worldwide level.

 

Team:

Audit team within the Pharmacovigilance Division, reporting to the Managing Consultant of the team.

 

Who we are looking for:

Those who dare to make the difference – in the way they act, collaborate, advise and lead. We are looking for a highly motivated and experienced professional who is able to quickly adjust to different working environments. A high degree of flexibility in working with different companies and people is required. An open eye for the needs of your clients and the ability to adjust to these needs and function as a partner and advisor to the client is essential. You need to have a pharmacovigilance, medical or paramedical background or a degree in life sciences in combination with a solid knowledge of international pharmacovigilance regulations and guidelines. At least 5-10 years of experience in various roles within pharmacovigilance area or within the pharmaceutical industry with safety related roles, government agency or a PV consultancy organization is an absolute requirement. Audit experience is required and QPPV experience is preferred.

 

The position:

Being a Xendo Auditor you will have the opportunity to work in a wide variety of projects for different companies. This position as (senior) consultant is for the auditors team of the Pharmacovigilance division. Your audit activities will cover the entire range of PV processes, including  from inspection support of our clients, Mock Inspections/ HQ audits, local affiliates/partners/vendors or tailored to a specific PV process. For our various longstanding clients, audit project management and maintenance of a good client relationship will also be an important part of your work. Training clients’ staff on PV regulations or assist in inspection preparations may also be part of your role. Our team is multinational, with several team members working home-based full time.
You may also be assigned as (deputy) QPPV to one or more clients. This concerns mainly smaller and medium-size companies, who often have a PV system under development or are undergoing major changes with (initial) marketing authorization applications. Your input as PV expert is key to these clients, but in addition we also consider (deputy) QPPV work experience a great asset to our auditors’ qualifications as they are through this role involved in all pharmacovigilance relevant processes and procedures of the client.

 

Your profile:

  • Medical or paramedical background or degree in life sciences;
  • Solid knowledge of international pharmacovigilance regulations and guidelines;
  • At least 5-10 years of experience in various roles within pharmacovigilance within the pharmaceutical industry, government agency or a PV consultancy organisation;
  • Audit experience is a must;
  • Good communication and interpersonal skills;
  • Able to quickly adapt to different working environments and the different cultural aspects of our clients;
  • Client-oriented, dedicated, flexible, able to manage timelines and prioritize your work;
  • Excellent knowledge of and experience with pertaining international legislation, guidelines and directives and able to assess the impact of changes in your areas of expertise
  • Proficient in English language, both in speaking and in writing. Good command of a second language is an advantage.

 

Information:

Please contact Helena van den Dungen, Director Pharmacovigilance at +31 71 524 40 00 or by e-mail for additional information on job specifics.

 

OUR OFFER:

  • a dynamic and varied position in a fast-growing and professional company;
  • good terms of employment;
  • focus on continuously extending knowledge and experience;
  • great projects in all aspects of GxP compliance and validation;````````````````````````
  • projects at both small and large life science organisations and suppliers.

 

Applying:

If you are interested in this position, we encourage you to send your motivation and CV to us.

Agency or sales calls are not appreciated

csv consultant

#Senior Consultant (Computer) Validation

As a Senior Consultant of the Engineering & Technical Support Division you will often have a detailed project contract with the client, specifying your activities and the expected results. You will predominantly work on location, but also from home or from Xendo’s Leiden office. Project’s duration can vary from one week (for high level advice/gap analyses) to several months. In short: you feel comfortable in a position that allows you to apply and further increase your knowledge and expertise in the area of GxP compliance and validation. This, amongst others, is your contribution in aim to provide better products for patients.

 

Company

Xendo is a consultancy and project management organisation in the (bio) pharmaceutical and medical devices and healthcare fields, meaning that your clients are operating in the life science sector. Thanks to our multi-disciplinary, knowledge driven approach, Xendo can deliver a broad palette of services to the life sciences industry, applying the right colour to projects that we participate in. For over 25 years, we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, established multinational companies and organisations.

 

Team:

IT & Automation within the Engineering & Technical Support Division, reporting to the managing consultant.

 

Who we are looking for:

Those who dare to make the difference – in the way they act, collaborate and lead. As Senior Consultant you will have the opportunity to share your extended knowledge in the field of IT & Automation with Xendo’s clients and closely collaborate with colleagues across divisions. Addressing new challenges and finding innovative solutions is your prerogative. Mostly working on-site, at the client's premises, you welcome independent responsibility for your projects. 

The position:

As a Senior Consultant you will be assigned to (IT) compliance projects within the pharmaceutical, medical devices and life sciences industries. You will mainly work in laboratory, production and validation departments, so knowledge of and experience in these departments is an advantage. Knowledge of GxP and validation combined with a feeling for IT and compliance is a requirement. Your job is to contribute to improving or establishing the clients’ (IT) compliance by providing them with the best possible assistance with their issues. As a Senior Consultant you work on validation projects as project manager, high level consultancy projects in which you advice the client on the validation strategy for implementing IT solutions or interim management functions. In these roles you need besides in-depth knowledge about GxP compliance, good communication skills, persistence and an agile working attitude.

 

Your profile:

  • Bachelor’s or Master’s degree;
  • at least 5 years of experience with GxP compliance and validation in the life sciences sector;
  • experience with validation of computerized systems
  • good communication skills and interpersonal skills;
  • client-oriented, dedicated, flexible, proven project management skills with helicopter view and able to quickly switch between different assignments
  • good understanding of GAMP, Annex 11 and 21 CFR Part 11;
  • excellent in both Dutch and English language.

 

Information:

Please contact Joost Havers, Managing Consultant at +31 71 524 40 00 or by e-mail for additional information on job specifics.

 

OUR OFFER:

  • a dynamic and varied position in a fast-growing and professional company;
  • good terms of employment;
  • focus on continuously extending knowledge and experience;
  • great projects in all aspects of GxP compliance and validation;
  • projects at both small and large life science organisations and suppliers.

Applying:

If you are interested in this position, we encourage you to send your motivation and CV to us

#CONSULTANT CMC REGULATORY AFFAIRS

As a result of the continuous growth of our company including our Regulatory Affairs Division we are looking for experienced professionals in Regulatory Affairs CMC. We offer a challenging environment working within our teams and for a wide range of clients in a role as (senior) consultant RA-CMC.

Being a consultant you will work on a wide range of projects that may cover the complete life cycle of a product from (early) development up to post approval maintenance. The projects range from small molecules to biologicals depending on your knowledge and experience. You can be assigned to customers looking for hands-on support and/or requiring advice on regulatory-CMC. The work may cover all aspects of RA-CMC ranging from development and advise on RA-CMC strategies, implementation of RA-CMC requirements in product development, support in scientific advice procedures, communication with health authorities and RA-CMC (Module 3, IMPD) technical writing. You may work at different sites which may be the office of our client, Xendo office or home based depending on the project requirements. Communication skills are key as you will communicate with many different functions within our client organisations like: RA, QA and QC functions, development, manufacturing but also with health authorities.

YOUR PROFILE

We are looking for highly motivated professionals who like to act in a dynamic environment and are able to adjust to different working environments. You are a self-starter and quick learner with excellent communication skills. A high degree of flexibility in working with different companies and people is required. An open eye for the needs of your customers and the ability to adjust to these needs is essential. Experience in CMC Regulatory Affairs within the (bio)pharmaceutical industry or health agencies is preferred. For the role of senior consultant several years in a (senior) CMC related position are required. Depending on your experience it is not an absolute requirement that the candidate will be based in the Netherlands. Fluency in English is required.
You aim for a consistent high quality in your work and deliver on your commitments. You are able to manage timelines and prioritize your work. You are also well aware of the regulatory legislation, guidelines and directives and are able to assess the impact of regulatory changes on the products or portfolio of your customers.

OUR OFFER

We offer a responsible, independent position in a growing and ambitious organization, with the opportunity to develop yourself. We offer a competitive salary and secondary benefits. Xendo has a professional but informal working environment, an extended development program on hard and soft skills, a flexible and pleasant work atmosphere and over 200 international colleagues.

APPLYING

If you are interested in this position, we encourage you to send your motivation and CV to us with the form below.

Agency or sales calls are not appreciated

#SENIOR PROJECT MANAGER PHARMACEUTICAL FACILITIES

The Engineering & Facility Support Division is strengthening its engineering team with a Senior Project Manager Pharmaceutical Facilities. Are you an experienced engineering professional with a proven track record in project management and looking for challenge and growth, then this might be your chance! Xendo is a consultancy and project management organization in the (bio) pharmaceutical and medical devices and healthcare fields, meaning that your clients are operating in the life science sector.

As a Senior Project Manager Pharmaceutical Facilities, you will be responsible for the executing of engineering tasks within multiple projects with a medium to long lead time (0.5 – 4 years). You will manage engineering projects both individually and within a multi-disciplinary team where you will have great influence and responsibilities. Your assignments will vary from conceptual or basic design of new laboratories or manufacturing facilities to consultancy and advice on maintenance management and improvement of maintenance planning as well as technical audits. You will be responsible for realizing all work, in accordance with the agreed budget, timescale, quality and performance criteria within the required procedures (health and safety, GMP, local and corporate standards). At times, you will work at the premises of our clients, but also from the Xendo office in Leiden. With your extended experience in facility engineering and project management, you would be considered a great and valuable asset to our company. You will report directly to the Managing Consultant Facility Engineering.

With your extended experience in facility engineering and project management, you would be considered a great and valuable asset to our company, reporting directly to the Managing Consultant Facility Engineering.

YOUR PROFILE

  • Bachelor’s or Master’s degree in Mechanical Engineering or Installation Technology;
  • Knowledge and experience in the pharmaceutical industry (GMP environment) is a must;
  • Solid Project Management (5-10 years) experience with specific experience within (bio) pharmaceutical (or related industries) and GMP.
  • Project Management skills;
  • Communicative and interpersonal skillset;
  • Customer oriented, passionate and able to effectively switch between different assignments;
  • Ambitious and enthusiastic relation builder with a quality driven mindset;
  • Excellent proficiency in English and Dutch language

OUR OFFER

  • a dynamic and varied position in a fast-growing and professional company;
  • good terms of employment;
  • Engineering, Project and Interim Management at multiple clients;
  • Our projects span a wide range and in different phases in facility life science; an extended development program on hard and soft skills.

APPLYING

If you are interested in this position, we encourage you to send your motivation and CV to us with the form below.
Agency or sales calls are not appreciated

#SR FACILITY ENGINEER PHARMA

The Engineering & Facility Support Division is expanding its engineering team with a Consultant Facility Engineering. Are you an experienced engineering professional looking for challenge and growth, then this might be your chance!

Xendo is a consultancy and project management organization in the (bio) pharmaceutical and medical devices and healthcare fields, meaning that your clients are operating in the life science sector. As a Consultant Facility engineering, you will be responsible for the executing of engineering tasks within one or more projects with a medium lead time (0.5 – 1 year). You will manage engineering projects individually and within a multi-disciplinary team where you will have great influence and responsibilities. Your assignments will vary from conceptual or basic design of new laboratories or manufacturing facilities to consultancy and advice on maintenance management and improvement of maintenance planning as well as technical audits. All work undertaken needs to be in accordance with the agreed budget, timescale, quality and performance criteria within the required procedures (health and safety, GMP, local and corporate standards). At times you will work at the premises of our clients, but also from the Xendo office in Leiden. With your extended experience in facility engineering and preferably project management you would be considered a great and valuable asset to our company. The Consultant will report directly to the Managing Consultant Facility Engineering.

YOUR PROFILE


• Bachelor’s or Master’s degree in Mechanical Engineering or Installation Technology;
• Solid engineering (5-7 years) experience with specific experience within (bio) pharmaceutical (or related industries) and GMP is desirable.
• Project Management skills; experience in planning, designing and programming projects and preparing estimates using up-to-date IT tools
• Communicative and interpersonal skillset;
• Customer oriented, passionate and able to effectively switch between different assignments;
• Ambitious and enthusiastic relation builder with a quality driven mindset;
• Excellent proficiency in English and Dutch language

OUR OFFER


• a dynamic and varied position in a fast-growing and professional company;
• good terms of employment;
• Engineering, Project and Interim Management at multiple clients;
• Our projects span a wide range and in different phases in facility life science;
• an extended development program on hard and soft skills.

APPLYING


If you are interested in this position, we encourage you to send your motivation and CV to us with the form below.


Agency or sales calls are not appreciated

analytics gmp

#Consultant analytics/GMP

Within our Division Compliance & Validation we are recruiting for a Consultant Analytics /GMP who is ready to enter the world of consultancy. As a Consultant you will work in an ever-changing and challenging environment at our clients in the life sciences industries (e.g. (bio) pharmaceutical industry, medical devices, CMOs). You will act as the expert providing support in diverse development as well as GMP projects, e.g. analytical method development and/or validation, lab process improvements and tech transfer. You will also co-develop new R&D and GMP services for Xendo clients within the life science industry. Based on your affinity and experience with GMP (USA and EU) and your expertise in quality management you contribute to the quality (laboratory) management of our clients.

Usually, the work takes place at the clients’ site and entails working in a team of specialists in which related topics such as active substance, drug product, quality and regulatory aspects are discussed.

Currently our Analytics team is involved in the development of a broader range of services to support our customers in improving their processes. As a new team member you are challenged and invited to bring forward your expert ideas to contribute to these new or improved services.


YOUR PROFILE:


For this role, we are looking for candidates with solid experience (4-6 years) in development (R&D), analytical methods for bioprocessing and/or QC testing of biologicals in the life science industry.
You have a bachelor or a master degree in Life Sciences (e.g. biology, (bio) chemistry, biotechnology, biomedical sciences or pharmacy). It is expected that you are able and willing to dig into the details yet keeping an eye on the overall goal of the project. You are result- and client oriented and have adequate interpersonal skills. You feel comfortable working with deadlines in an often changing environment and see it as a challenge to solve issues in a pragmatic and proactive way.
To be successful as a Consultant Analytics/GMP you also have:


• Hands-on knowledge of bio-analytical methods and preferably microbiological test methods;
• Excellent knowledge of requirements for method validation/transfer within a GMP environment;
• Good understanding in GMP, Annex 15 and regulatory requirements related to analytical method development;
• Knowledge of sterile/aseptic manufacturing and/or environmental monitoring is a pre;
• Excellent in both Dutch and English language;


OUR OFFER:


• a dynamic and varied position in a fast-growing and professional company;
• good terms of employment;
• international projects in (bio-)analytical laboratories t both small and large pharmaceutical companies;
• a comprehensive development program on hard and soft skills.


APPLYING:


If you are interested in this position, we encourage you to send your motivation and CV to us with the form below or by email to .

regulatory affairs

#(Senior) Consultant Regulatory Affairs

The position

As a result of the continuous growth of our company and the Regulatory Affairs Division we are looking for an experienced professional who like to expand his/her experience in Regulatory Affairs by working in a challenging role as (senior) consultant RA with a coaching function to junior colleagues in a project management setting.


The company

For 25 years Xendo is a leading consultancy organization for the (bio) pharmaceutical industry, medical devices and Life Sciences industry, based at the Bio Science Park in Leiden. In recent years Xendo successfully delivered projects for more than 300 clients. Xendo has an excellent international reputation as a consultancy organization. Most of the work is performed in the Netherlands and Germany, but on an EU and Worldwide level. Our expertise lies in Regulatory Affairs, Pharmacovigilance, OPEX/Quality Management, Engineering, Qualification & Validation, Product Development and E-Compliance & Data Management.

The environment

Being a consultant you will have the opportunity to work in a wide variety of projects and companies. Assignments may cover all aspects of regulatory affairs ranging from pre-approval and scientific advice meetings to regulatory maintenance, from CMC to regulatory project management and from work on small molecules to high-tech (biological) products.

Depending on your expertise, experience and interest you will be assigned to customers looking for hands-on support and/or requiring advice on regulatory strategic issues. The duration and size of the projects can vary from months to years, from 5 days a week to a couple of hours a month and from working at your own home to the office of the customer. Besides you will be the coach for associate regulatory affairs consultants and keep track of their work within in the different projects.

Your profile

You are an entrepreneur, able to think and act at a scientific level, who is able to quickly adjust to different working environments. A high degree of flexibility in working with different companies and people is required. An open eye for the needs of your customers and the ability to adjust to these needs is essential. At least 5-7 years of experience in regulatory affairs within the pharmaceutical industry or government agency is a requirement.

With these experience you are curious about new opportunities for yourself, the client and Xendo, a self-starter and quick learner with excellent communication skills. Your Dutch and English are fluent.

You aim for a consistent high quality in your work and deliver on your commitments. You are able to manage timelines and prioritize your work. You are also well aware of the regulatory legislation, guidelines and directives and are able to assess the impact of changes in this area on the products or portfolio of your customers.