Emplois les plus populaires

409Emplois trouvés

409 Emplois trouvés 

U
U

EEA QP for Pharmacovigilance (Braine L'alleud, Walloon Brabant, Belgium)

UCB

Braine L'alleud
Il y a 30+ jours
Braine L'alleud
Il y a 30+ jours

Help us transform patients' lives.

At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation.  Will you join us in our pioneering adventure?

To strengthen our global Patient Safety and Medical Management (PSMM) group we are looking for a talented individual that resides and operates in Europe to fill the position of EEA Qualified Person for Pharmacovigilance (EEA QPPV). This role will also take a global perspective in their contribution to the wider Patient Safety department. This role reports into the Head of Patient Safety and Medical Management (PSMM) and as such is a member of the PSMM Leadership Team

 

As the EEA QPPV you will hold an executive position with the objective of fulfilling the legal requirements of the EEA QPPV as defined by prevailing European legislation and also ensure that UCB operates in accordance with Pharmacovigilance EEA regulatory standards and that compliance risks are identified and mitigated.

 

You will work in environment that is defined by Legal Framework/Authority

  • The EEA QPPV is responsible for the establishment, maintenance, compliance and continuous improvement of UCB’s pharmacovigilance system in accordance with the legal framework for pharmacovigilance of medicinal products for human use in the EU given by the Regulation (EU) No 1235/2010 amending Regulation (EC) No 726/2004, by the Directive 2001/83, as amended in 2010 by Directive 2010/84/EU, as well as by the Commission Implementing Regulation (EU) N° 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities and in the associated guidelines of good pharmacovigilance practices (GVP)
  • At UCB, The EEA QPPV has oversight and exercises authority over the functioning of the Pharmacovigilance system in all relevant aspects, including its quality system, the EEA QPPV is a member of the following UCB Governance Bodies:
    • Pharmacovigilance Quality Council (PVQC)
    • Global Labeling Committee (GLC)
    • Benefit-Risk Board (BRB)
    • Individual Case Safety Report (ICSR) Quality Forum (IQF)
    • Recall Committee
    • Patient Safety (PS) Portfolio Governance Committee


You will contribute by focusing on the following main accountabilities:

  • Shall act as the single PV contact point for the national competent authorities and the Agency on a 24-hour basis and as a contact point for PV inspections
  • Shall be accessible continuously and when unavailable will nominate a back-up
  • Shall lead the network of other local QPPVs to ensure sharing of information and expertise
  • In relation to the PV system, is responsible for the establishment and maintenance of the UCB PV system in accordance with the legal framework for PV of medicinal products for human use in the EEA – supported by the PV Excellence team
  • In the EEA, this implies that the EEA QPPV shall:
    • have the authority to influence the performance of the company PV system and its related quality system in order to promote, maintain and improve compliance with the legal requirements
    • have oversight over the functioning of the PV system in all relevant aspects including the PSMF and the PV quality system
    • have an additional dotted line reporting to the Global Head of Internal Audit.  With this connectivity a Pharmacovigilance Auditing Committee occurs to provide top-line visibility of the PVQA risk assessments, audit plans, audit execution and CAPAs
  • In relation to the products for which UCB holds a marketing authorization in the EEA, specific responsibilities of the EEA QPPV include those described in GVP Module I and the maintenance of the overview on the specific tasks that are delegated
  • Understand the direction of travel of EU Authorities and enable UCB to proactively align with regulatory expectations
  • Support ongoing evolution of the PV system to prepare for the future by ensuring appropriate prioritisation of activities by a pragmatic approach balancing acceptable risk taking and effective targeting of available resources
  • Influences external environment and develops a strong within industry and regulators acts proactively as a UCB representative within external organizations (e.g. patient interest groups, industry trade associations, congress etc.)
  • Demonstrates integrity in decision making and builds trust inside and outside UCB

 

Back-up

  • Shall ensure that the deputy QPPV has all necessary information to fulfill the role, and that the 24 hour contact details of the EEA QPPV and deputy QPPV have been notified to all regulatory authorities in which marketing authorizations are held within their respective territories and to the Agency.


Interested? For this position you’ll need the following education, experience and skills:

  • A Medical Degree
  • At least 15 years’ experience within the Pharma Industry (medical or clinical development) with at least 8 years of experience in pharmacovigilance  
  • A strong focus on the patient in all decision making
  • Technical knowledge of EEA PV requirements and their implementation vs international requirements and in-depth knowledge of European regulations
  • Solid scientific/medical: Shall be highly qualified profile in PV and related matters such as medicine, pharmaceutical sciences as well as epidemiology, biostatistics, data integrity etc.
  • Pragmatic and Prioritization mindset to effectively balance risks in context of reality
  • Leadership skills
  • Leadership and decisiveness- ability to delegate, to choose the tasks and the levels of supervision that can be delegated,
  • Should be a central agent who assumes a lead role in PV and share experience and challenges with UCB local QPPVs (maybe a dotted line?)
  • Resilience and Patience
  • Excellent communication skills. strong communication skills & negotiating skills
  • Demonstrates integrity and inspires trust (internally and externally)
  • Has a long term vision for PV (for products authorized in the EEA) in the globalisation environment

 

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

 

In PSMM we have an experienced and committed leadership team who focus on the people in the team as well as the delivery of the strategic objectives. This means we have a very strong team who are supportive and collaborative who enjoy working together.

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.

About us.

UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. 

U
U

Neuro-pharmacologist (Braine L'alleud, Walloon Brabant, Belgium)

UCB

Braine L'alleud
Il y a 30+ jours
Braine L'alleud
Il y a 30+ jours

Help us transform patients' lives.

At UCB, we put our heart, soul and skills into making a difference for people living with severe diseases.  Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in this pioneering adventure? 

Neuro-pharmacologist for the Neuroscience Partnering team

 

Location: Braine-l’Alleud

 

Help us transform patients’ lives. At UCB, we put our heart, soul and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure ?

 

UCB is a leading global biopharmaceutical company developing innovative therapies to address unmet needs of patients suffering from severe disorders. The company’s global R&D organization “Early Solutions” is responsible from early research up to clinical Proof of Concept and focused on two main Therapeutic Areas, Immunology and Neurology. Immunology is based in Slough UK, while Neurology is based in Braine-l’Alleud, Belgium, close to the company Headquarter located in Brussels.

UCB New Medicines is recruiting for the site in Braine-L’Alleud a (m/f):

 

Neuro-pharmacologist for the Neuroscience Partnering team

 

Nature and Scope:

We are currently hiring a talented, senior in vitro or in vivo Neuro-pharmacologist to join the Neuroscience Partnering Team, which reports to the VP - Neuroscience TA, based in Braine L’Alleud, Belgium. At the interface between internal R&D, external R&D in pharma, biotech and academia and business development the Neuroscience Partnering Team plays a critical role in the development of our pipeline and provides a dynamic and stimulating environment for drug hunters.

The remits of the group include but are not limited to searching, evaluating and facilitating in-licensing of external and innovative drug discovery and development programs in order to enrich the Neuroscience portfolio. Also included are contributions to business negotiations, set-up of research programs and organizing alliance management at early stages of the collaborations. In order to achieve these goals, the group has access to a large panel of experts, available within or outside the organization.

 

To further strengthen our team, we are seeking a senior neuro-biologist or neuro-pharmacologist with a significant experience in discovery of drugs in the neurology area. Experience in the new therapeutic modalities such as viral gene-therapy is a plus.

Using his/her network, connections in meetings and available databases, the candidate will scout amidst pharmaceutical companies or academia for possible external assets or programs matching our strategic interests.

The function will also include acting as the due diligence expert lead/coordinator within a large DD team, with the aim to pro-actively provide recommendations to decision committees.

In this capacity, he/she will be autonomous in: (i) critically assessing results of in vivo and in vitro experiments; and (ii) provide a broader recommendation on opportunities by assembling an integrated view point.

 

Education, Experience &  Skills

The ideal candidate will have acquired his/her PhD in the field(s) of Neuroscience/Neuropharmacology, together with a postdoc in the field and 10 years experiences in a bio-pharmaceutical environment. A thorough understanding of different phases in pre-clinical drug discovery and hands-on project management is essential.

The candidate will

•            Have built a large network in the field of neurology,

•            understand partnering processes and have some experience in partnering with external companies

•            have a proven track record of publications in peer-reviewed, high-quality science journals

•            be open to innovation and driven by science

•            be able to clearly communicate scientific content in management committees

•            have the capacity to understand/deduce partner’s view and situation

•            have the necessary skills to work in a multidisciplinary environment (research, clinical, BD, legal, IP, ….)

•            have an adaptive sense for change management and for influencing the organization

•            be fluent in English (spoken and written), the official language for meetings and reporting

 

To apply please go to www.ucb.com/careers.

About us.

UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. 

V
V

Staff Scientist for VIB-VUB facility for Bio Electron Cryogenic Microscopy (BECM)

VIB

Brussels
Il y a 8 jours
Brussels
Il y a 8 jours

About the Center 

The VIB Center for Structural Biology houses research groups with strong expertise in protein biochemistry, X-ray crystallography, NMR, biophysics, nanobody technology, and electron microscopy.  Our department tightly collaborates with other VIB departments (www.vib.be) on cutting edge biological research problems ranging from human diseases to plant biotechnology.

Job description

The VIB Center for Structural Biology (CSB) in Brussels seeks to recruit a Cryo-electron Microscopy (cryo-EM) scientist to support and develop single-particle and tomography projects.

The research scientist will be appointed to the VIB-VUB facility for Bio Electron Cryogenic Microscopy (BECM, www.becm.be), which serves as a technology platform for CSB.

BECM has a state-of-the-art facility for cryo-electron microscopy and houses a JEOL cryoARM300 equipped with an in-column energy filter, phase plate, and K3 detector and is complemented by two screening JEOL JEM-1400 120 kV microscopes. The facility was established in 2018 and serves a large community of users including users from VIB, Belgium, and Europe from academia and industry.

Key responsibilities

  • Support a range of cryo-EM projects through interaction with CSB and external scientists
  • Contribute to the maintenance of the microscopes
  • Contribute to the development of single-particle cryo-EM and/or implementation and development for state-of-the-art tomography
  • Provide user training in experimental and computational aspects of cryo-EM

Profile

Key Experience and competences

  • Master degree in Natural Sciences or higher
  • At least two years of work experience in electron microscopy
  • Basic knowledge of Linux and programming skills
  • Good communication skills in English

Desirable

  • Experience in structural biology
  • Experience in single-particle or cryo-tomography data collection and analysis
  • Flexible working practice
  • Ability to troubleshoot
  • Experience with multi-user facilities

How to apply?

Motivated candidates are asked to apply online.

Deadline until a suitable candidate is found.

For further inquiries please contact Marcus Fislage (

marcus.fislage@vub.vib.be

)

U
U

Group Leader Upstream Process Sciences (Braine L'alleud, Walloon Brabant, Belgium)

UCB

Braine L'alleud
Il y a 30+ jours
Braine L'alleud
Il y a 30+ jours

Help us transform patients' lives.

At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation.  Will you join us in our pioneering adventure?

 

To strengthen our Upstream Process Sciences Team, basedin Braine, Belgium we are looking for a talented individual to fill the position of:Upstream Process Sciences Group Leader.

As anUpstream Process Sciences Group Leader, your main responsibilities are:

  • To contribute defining the strategy and the team for late stage upstream process development of our UCB’s therapeutic protein molecules.

 

  • To define, develop and implement advanced principles and techniques for the process development and production of large molecule therapeutics.

 

  • To manage a diverse and dynamic workforce of scientists/team.

 

  • To collaborate with internal and external partner functions in New Medicines (research), Biotechnological Process Sciences, Technical Operations and Contract Manufacturing Organizations.

 

  • To build and maintain effective collaborations with contract manufacturing organizations, external suppliers and academic network.

 

  • To liaise and promote the technical and scientific exchange with other process development groups and partner departments.

 

  • To apply UCB’s health safety and environment policies and rigorous standards. Participate in continuous improvements of HSE by conformance checks on laboratory set-up, construction and organization as well as day-to-day standards and procedures in close collaboration with the HSE department.

 

  • To ensure:
  • Upstream process development and characterization of UCB’s protein molecules.
  • Support CMC regulatory filings for cell culture processes.
  • Material supply for toxicology studies.
  • Deep scientific support for investigations, post-launch process enhancements, technology transfers and the development and characterization of next generation processes post-approval.
  • Timely delivery of process characterization, support for scale up and scale down, as well as validation support.
  • Innovation for upstream process sciences to offer leading edge manufacturing process options. Define the biopharmaceutical upstream processes of the future.
  • Definition of upstream process control strategies.

 

  • To participate in the transfer of processes from small scale development units to the pilot plant and to commercial manufacturing sites.

 

  • To utilize process and laboratory derived data to support technical investigations and aide in process optimization/development.

 

  • To supervise and perform daily laboratory activities relating to media making, cell banking, inoculum and fermentation/cell culture process development and characterization as well as in process analytical methods. Provide technical expertise in matters regarding cell culture process development.

 

  • To author and/or review technical reports, process summaries, protocols, and quantitative analyses for regulatory filings.

 

Interested? For this position you’ll need the followingeducation, experienceand skills:

  • Phd’s or Master’s preferred.
  • At least 5 years of experience in a similar role with upstream bio-processing, particularly involving yield improvements and including systematic trouble-shooting.
  • Proven track record of drug substance commercialization and manufacturing science & technology, technology transfer expertise for monoclonal antibodies.
  • Working knowledge of downstream & analytics.
  • Fluent in English, both spoken and written. Good knowledge in French.

 

Soft skills:

  • Very good communication skills in order to maintain good working relationships with internal customers and external customers.
  • Strong collaborative and motivational skills.
  • Ability to manage multiple programs in matrix environment.
  • Ability to work strategically as well as in a detail-oriented framework.
  • Ability to lead problem solving for process issues relating to upstream processes.
  • Ability to prioritise project work and make effective use of available resource to meet agreed timelines.
  • Ability to author and approve comprehensive and accurate protocols/reports.
  • Ability to select, implement and use appropriate data management concepts and tools.

 

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

 

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.

About us.

UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. 

P
P

Computational Toxicologist (M/F/X)

Procter & Gamble

Brussels
Il y a 30+ jours
Brussels
Il y a 30+ jours
Are you looking to start an exciting career? Procter & Gamble's Global Product Stewardship function has an immediate entry level opening for a PhD level scientist in the area of Computational Toxicology and Human Safety.
Are you ready for the challenge? “Do something that matters”!
You will apply computational toxicology expertise and provide human safety support for current business, upstream technologies, and research; concentrating on how safety assurance can be provided for the general use of consumer products. You will need to understand and utilize current toxicological evaluation and product stewardship approaches to ensure that products are acceptable for their intended use and meet regulatory requirements. You will evolve in a technically exciting and globally diverse business environment.
With us you will:
* Work with the Corporate and Sector Human Safety organizations to support safety assessment work and research projects. This will include working collaboratively on the use, development, and application of computational tools and methodologies, including the implementation of computational modelling into our work streams. This work will include the application of big data and machine learning.
* Utilize computational toxicology expertise to provide regulatory toxicology support for global chemical compliance programs (e.g., REACH, etc.).
* Communicate complex computational approaches and methodology to non-computational scientists and other partners.
* Develop collaborative working relationships with toxicology colleagues and product development teams across the globe.
* Maintain appropriate collaboration with related functions in the areas of Data Science, Modelling and Simulations, Regulatory Affairs, and External Relations.
What can we offer you?
At P&G, Day 1 starts with you making an impact on the world, P&G brands, and your career. You’ll be at the core of breakthrough innovations, be given exciting assignments, lead initiatives, and take ownership and responsibility. Also, we provide creative work spaces where new ideas thrive. All the while, we will offer you extraordinary training and development to help you become a leader in your field.
And it’s not just about what you will do, but how we will make you feel: encouraged, valued, purposeful, challenged, heard, and supported!
Apply if you have:
* PhD in a Toxicology, Computational Toxicology, Computational Chemistry, or Pharmacology, with strong computational and chemistry background.
* Background in developing and applying computational approaches, as well as experience using big data, systems biology modelling, and machine learning is essential.
* Ability to apply basic scientific skills in a fast-paced business environment, as well as the ability and capacity to learn contemporary risk assessment processes and related disciplines critical to providing assurance of safety for consumer products.
* Demonstrated excellent interpersonal and communication skills with the ability to work effectively in a global team environment.
Just so you know:
P&G was founded over 180 years ago as a simple soap and candle company. Today, we have built this company into world’s largest consumer goods firm and home to iconic, trusted brands that make life a little bit easier in small but meaningful ways. We have a deep understanding of our market and strive to deliver innovation to our consumers. We’ve spanned three centuries thanks to three simple ideas: leadership, innovation and citizenship. We believe insight, innovation and passion of hardworking teams has helped us grow into a global company that is governed responsibly and ethically, that is open and transparent, and that supports good causes and protects the environment.
This is a place where you can be proud to work.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Job: *Research & Development*
Title: *Computational Toxicologist (M/F/X)*
Location: *BE-Brussels-Capital Region-Brussels*
Requisition ID: *RND00004808*
P
P

R&D – Internship – Thesis Project Associate Researcher for Professional Bachelor at Belgian Hogeschool /Haute Ecole (m/f/x)

Procter & Gamble

Brussels
Il y a 30+ jours
Brussels
Il y a 30+ jours
*Are you curious about the chemistry and technology behind our products?*
*
*
Then Procter & Gamble might have an exciting Bachelor Internship project for you at our Brussels Innovation Center (located in Strombeek-Bever)!
We are offering*internship projects*to students studying a Professional Bachelor in STEM subject areas (e.g. Chemistry, Biotechnology, Process technology) at a Belgian University of Applied Science: Hogeschool or Haute Ecole. What does it take to come up with some of the world’s most well-known brands? Well, a whole lot of science, to start with. Our Researchers at P&G go to work, making and improving the products for billions of consumers who use products like Gillette, Dash, Swiffer and Pampers every single day.
We’re talking big innovations, small bets, groundbreaking technology, state-of-the-art labs, micro-scale plants and a team full of inventors to make this happen!
*The internship projects can have the following content:*
* Define and/or optimize new formulations based on surfactants, polymers etc., to meet product performance standards, in close collaboration with key formulators within the formulation labs of the product specific departments (product design);
* Optimize and/or develop new/existing test methods to measure/quantify the performance of the different product categories (product design);
* Investigate and study the behavior of key ingredients within the formulations to better understand the performance profile of different products using a range of measurement techniques. These techniques are available in the different labs on site (product design);
* Define and understand which impact the different parameters of the product-making-process have on the finished product characteristics and aesthetics (process);
* Evaluate the impact of changing the process parameters from laboratory scale (2 kg scale) to Pilot Plant (150 kg - 1 ton scale) and up to Plant scale (40 ton scale) on the finished product characteristics and aesthetics (process);
* Evaluate and assess new packages for Household Care products using existing/new test methods within the R&D packaging department (packaging);
* Define, evaluate and/or optimize new/existing Analytical test methods that characterize Household Care products within the Analytical department (analytical).
*What we offer you:*
* Meaningful work as of Day 1;
* Support by your thesis coach and team;
* An exciting project where you can put your technical skills to work on challenging problems;
* Work with people of different nationalities and cultural backgrounds;
* Develop yourself through professional training and on-the-job mentorship;
* Internship allowance for transportation and meal.
*You are a good fit if:*
* You are studying a Bachelor Degree (in STEM subject areas) at a Universities of Applied Science, Hogeschool or Haute Ecole;
* You are passionate about creativity and innovation;
* You are autonomous and have a real collaboration spirit.
*Just so you know:*
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, or disability status.
Job: *Research & Development*
Title: *R&D – Internship – Thesis Project Associate Researcher for Professional Bachelor at Belgian Hogeschool /Haute Ecole (m/f/x)*
Location: *BE-Brussels-Capital Region-Brussels*
Requisition ID: *RND00004606*
U
U

IT Solution Expert Clinical Systems (Braine L'alleud, Walloon Brabant, Belgium)

UCB

Braine L'alleud
Il y a 30+ jours
Braine L'alleud
Il y a 30+ jours

Help us transform patients' lives.

At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation.  Will you join us in our pioneering adventure?

 

At UCB, every day starts like: “how can I help to improve the lives of patients living with severe diseases”. We also recognize that data and technology are instrumental in the way we invent, develop, manufacture and market our innovative solutions to deliver patient value and improve patient experience in new and ambitious ways.


Within the global UCB IT organization, the mission of the Core Clinical Systems team is to accelerate and transform the way UCB delivers differentiated patient solutions, by implementing and maintaining state-of-the-art clinical development systems.


We are looking for a unique individual to strengthen our team.


As IT Solution Expert Clinical Systems, you will manage and improve core clinical systems to meet the needs of the accelerating and transforming clinical development processes. This includes creating new automated data flows to increase the data available, speed of access and the capability to gain insights from data. Also, you will ensure that the core clinical systems are kept in a validated and inspection-ready state throughout constant changes. You will collaborate with key stakeholders across the clinical development life cycle and various IT teams in Europe, the USA and Asia.


You will be based in Braine-l’Alleud (Belgium).


You see yourself immediately when reading…


•    Bachelor’s or master’s degree in IT, engineering, natural sciences or equivalent, preferably experience in the pharmaceutical industry
•    Ideally experience in project management, process design, computerized system validation, system maintenance, change management, testing, incident-, access-, knowledge management
•    Ideally experience with electronic data capture, clinical data management, clinical trial management and trial master file management
•    You are passionate about technology and application of it to advance healthcare and improve the lives of patients
•    Cross functional team player engaging stakeholders in value creation in a globally diverse cultural environment
•    You love to drive innovation and curiosity is how you learn
•    Open to big challenge and challenging the "as is" state
•    Your attention to details ensures UCB's core clinical systems operate flawlessly
•    Market our value: You can qualify and quantify the benefits of solutions/systems/products and showcase this
•    Fluent in English


Why you should apply


Do you want to contribute in bringing real value to patients living with severe diseases while driving innovation forward? 


Join UCB’s dynamic, inspiring and innovative environment and team. You will be recognized for impactful performance via a competitive compensation and benefits package and you will enjoy ample personal development opportunities.


Tell us what makes you the perfect match to our team and join one of the most dynamic & forward-looking IT organizations in the world.

About us.

UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. 

F
F

Graduate Intern Public Affairs Consultancy – Environment (Chemicals & Circular Economy)

Fleishman-Hillard

Brussels, Brussels
Il y a 26 jours
Brussels, Brussels
Il y a 26 jours

FleishmanHillard’s Brussels office is seeking a graduate intern to support its Environment & Chemicals practice.

 

FleishmanHillard in Brussels is Europe’s leading EU public affairs and communications consultancy. We have an excellent track record of advising blue chip clients as they navigate regulatory, political and policy issues of substantial commercial and societal significance. We advise our clients on the implications of legislative and other policy developments for their organisations, and develop advocacy strategies that help them meet their objectives and enhance their positioning. Our approach hinges on close partnership, offering deep expertise and applying insight as well as creativity to our clients’ issues.  


We are looking for a Graduate intern with an interest to work in the environment & chemicals policy field, to join this established practice and gain professional experience in EU public affairs.

The successful candidate will assist in the implementation of public affairs programmes for market-leading global accounts. Based on his/her daily monitoring of relevant information sources and reporting on key developments, he/she will assist with preparing draft reports, presentations and issue analysis relevant to our clients.

  • 6-month paid internship
  • Starting date: asap

Experience required

  • We are considering postgraduates, and graduate students currently doing their master at university in courses such as political science or business where there is a strong European focus
  • Good understanding of EU policymaking and a true interest in environment / chemicals sector

 Skills & Competencies required

  • Basic understanding of environment / chemicals sector and of policy issues most impacting that sector
  • Excellent oral and written communication in English is a must; fluency in one or more other languages is a plus
  • Commitment to the highest standards of service delivery
  • Ability to manage multiple issues and deadlines
  • Entrepreneurial and creative approach to problem solving
  • Ability to build and maintain trusting relationships
  • Dynamic, supportive, collaborative and willing team player
U
U

Gene Therapy Laboratory Leader (Braine L'alleud, Walloon Brabant, Belgium)

UCB

Braine L'alleud
Il y a 30+ jours
Braine L'alleud
Il y a 30+ jours

Help us transform patients' lives.

At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation.  Will you join us in our pioneering adventure?


UCB is a leading global pharmaceutical company, dedicated to the research, development and commercialization of innovative pharmaceutical and biotechnology products in the areas of Neuroscience, Immunology and Oncology. The organization employs some 9000 individuals across approximately 40 countries.  UCB is a pharmaceutical company with a size which enables it to deliver a significant drug pipeline, whilst remaining agile and innovative. For our talented scientists there is plenty of scope to influence the pipeline and make a difference to patients and great potential to influence the strategy and drive the science. UCB remains a great opportunity for the individual to get a breadth of experience of the drug pipeline from research through to the clinic, whilst working in a highly collaborative environment to learn, contribute and gain visibility in a scientific and cross-functional setting.


The Translational Biomarkers and Bioanalysis (TBB) Department is positioned within the function of Development Sciences, a division which provides strategy and support to transition novel pharmacological assets, including gene therapy derived assets, from research into the clinic. TBB operate and collaborate closely across the organization to support bioanalysis and biomarker activities. 


We are looking for a dynamic technical leader to drive bioanalytical technology strategy to support UCBs gene therapy portfolio.  The ideal candidate will be a highly motivated self-starter with extensive experience in developing bioanalytical assays across multiple technology platforms used to support biodistribution, vector shedding as well as gene expression and assessment of immunogenicity of gene therapy products in pre-clinical and early clinical development.  The ideal candidate will have a proven track record leading scientific and technical teams in development and validation of PCR and/ or cell based neutralizing immunogenicity assays.  You will also contribute to the technical transfer of assays to external partner laboratories ensuring efficient transfer of assays capable of meeting regulatory standards.  

 

The successful candidate will have extensive experience, a strong scientific background, good written and verbal communication skills and be able to multi-task effectively and adapt to meet the demands of a fast-paced matrix-team environment. 

 

The role is based in Belgium in Braine l’Alleud. 

 

Skills and experience:

 

Required

 

  • Candidates should have a BSc and preferably a PhD in a biological discipline
  • Proven track record as a scientific leader responsible for talent development 
  • Extensive and proven experience of working in the area of gene therapy and bioanalysis
  • Clear practical expertise in the development of fit-for-purpose analytical methods to assess PK and Immunogenicity for Gene Therapy assets such as,
    • Cell-based methods including Cellular Transduction Inhibition Neutralising antibody assays and ELISPOT.
    • PCR-based methods including qPCR, ddPCR and/or RT-qPCR
    • Other technologies
  • Ability to lead a successful team in a dynamic laboratory ensuring delivery of high-quality, key analytical methods, according to project timelines.
  • In depth knowledge of regulatory expectations of bioanalytical assays to support gene therapy assets 
  • Extensive knowledge in the validation requirements of such assays that can stand up to scrutiny by regulatory authorities
  • Demonstrate multi-tasking and adaptability to changing project and organizational priorities, consistently aligning with departmental needs 
  • An ability to work in a matrix, disseminate key data and communicate clearly to stakeholders, colleagues and project scientists, discussing ideas, provide constructive challenge and useful feedback
  • Proven track record of developing novel solutions in a discovery, and preferably a clinical setting
  • Demonstrated ability to generate, analyse and present critical data sets in collaboration with statisticians and other colleagues
  • A keen understanding of the impact of biological and assay variability on experimental design and delivery


Preferred

 

  • Experience with AAV-based gene therapy projects and bioanalysis.
  • Experience with molecular biology applications such as qPCR, ddPCR, transcriptomics.
  • Experience with cell-based assays such as Cellular Transduction Inhibition, ELISPOT.
  • Effective ability to progress assets from Research into Clinical Development
  • Previous experience of working in a pharmaceutical drug discovery and assay development environment.
  • Demonstrating knowledge of the latest regulatory standards and industry best practices.
  • An understanding of biomarkers would be a distinct advantage
  • Experience working with a wide range of internal stakeholders including Therapeutic Area, Non-Clinical Safety, DMPK, Translational Medicine, Clinical Pharmacologists, Clinical operations and Quality Assurance colleagues.
  • Established track record of working with Clinical Research Organizations in support of method development and validation.
  • Good working knowledge of neuroscience, immunology and / or cancer biology
  • Experience of working as a departmental representative in a project matrix
  • Clear grasp of context of use (linking assay requirements to the usage of the data generated) of biological data

 

Role and Responsibilities:

 

  • You will employ your proven expertise to lead a successful laboratory driving the development and delivery of advanced bioanalytical solutions supporting the implementation of cell-based immunogenicity and genomic PK assessments in support of our Gene Therapy pipeline.
  • Provide technical advice and guide the development and characterisation of bioanalytical assays for gene therapy assessts.
  • Play a key part in delivering the strategy of the TBB team to ensure and input into the gene therapy strategy
  • You will act as subject matter expert, supporting project teams on bioanalytical considerations, and employ your expertise for the development of complex assessments to ensure delivery of high-quality fit-for-purpose assays in a non-regulated environment
    • Develop qPCR assays for measuring pharmacokinetics in a range of non-clinical and clinical sample types 
    • Develop cell-based immunoassays to measure immunogenicity in a range of non-clinical and clinical sample types.
  • Work with key stakeholders to ensure prioritization and optimal deployment of technologies
  • Represent and align with the objectives of Development Sciences internally and externally in matters relevant to biomarkers and bioanalysis 
  • Provide in-depth knowledge of assay development and troubleshoot technical challenges across multiple platforms
  • Work within the Bioanalytical area to optimize experimental design, troubleshooting, sample analysis, data interpretation and report generation
  • Provide technical expertise on transfer of assays, both internally and to external partners. 
  • Work with CROs and other external providers to transfer and deliver key assays to project and study deadlines
  • You will have in-depth knowledge of bioanalytical tools to provide scientific and technical input to Project teams, Biomarker teams and Development Sciences teams
  • Ensure compliance with all health and safety, HTA, other regulations 
  • Maintain an awareness of new / emerging techniques and tools relevant to the field to ensure the group remains state of the art.
  • Work with scientists in discovery and the therapeutic areas as well the clinical scientists to develop and implement novel assays
  • You will have in-depth knowledge to provide scientific and technical input to Project teams and Development Sciences teams
  • Liaise with statistics to ensure optimum design of experiments
  • Ensure compliance with all health and safety regulations 
  • Develop and grow links with key academic collaborators
  • Work within collaborations with external partners, academic institutions, CROs and consultants as required.

 

About us.

UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. 

U
U

Analytics Technology Lead (Anderlecht, Brussels, Belgium)

UCB

Anderlecht
Il y a 30+ jours
Anderlecht
Il y a 30+ jours

Help us transform patients' lives.

At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation.  Will you join us in our pioneering adventure?

Within the global UCB IT organization, the Analytics Centre of Excellence is playing a crucial role in enabling stakeholders from numerous functional domains with efficient and innovative technology solutions in the areas of BI, Analytics and AI.

We are looking for a unique individual to strengthen our team.

As the Analytics Technology Lead, you will lead Global data science, AI and Advanced Analytics platforms management, integration and innovation. The role is based in Brussels, Belgium.

 

Your main responsibilities

As the Analytics Technology Lead, you will:

  • Manage the Lifecyle of Advanced Analytics platforms and their integration with other analytics platforms.
  • Be responsible for defining the advanced analytics technology platform roadmap and in charge of the maintainability and the scalability of the proposed solutions.
  • Manage the Rstudio, RShiny, Jupyter and other data science enterprise platforms and labs on premises and in the cloud (AWS and Azure), own the administration of such platforms and supervise the platform administration activities.
  • Manage the coordination and the integration of heterogeneous environments in line with the needs of end user and data scientists.
  • Lead the platform implementations/projects and manage the stakeholders and vendors involved, by showing advanced project management skills and ability to deliver technology projects in a matrix organization collaborating with the various departments involved like security, technology strategy and infrastructure.

 

You see yourself immediately when reading…

  • Eager to learn, discover and develop new Artificial Intelligence technologies and enable the integration across the different solutions.
  • Proficiency in concepts like statistical programming (e.g. R, Python), machine learning, smart data visualization (e.g. R-Shiny, Qlik Sense) and augmented analytics is required.
  • Familiar with frameworks involving structured and unstructured data (e,g. Hadoop, Spark, Relational and non-Relational databases).
  • Proficient with the management of Linux environments, Containers and knowledgeable of Kubernetes.
  • Good communication skills, team player.
  • Fluent in English

 

Why you should apply

Do you want to contribute in bringing real value to patients living with severe diseases while driving innovation forward?

Join UCB’s dynamic, inspiring and innovative environment. You will be recognized for impactful performance via a competitive compensation and benefits package and you will enjoy ample personal development opportunities.

Tell us what makes you the perfect match to our team and join one of the most dynamic & forward-looking IT organizations in the world.

 

About us.

UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. 

Date de publication

Il y a 30+ jours

Description

Help us transform patients' lives.

At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation.  Will you join us in our pioneering adventure?

To strengthen our global Patient Safety and Medical Management (PSMM) group we are looking for a talented individual that resides and operates in Europe to fill the position of EEA Qualified Person for Pharmacovigilance (EEA QPPV). This role will also take a global perspective in their contribution to the wider Patient Safety department. This role reports into the Head of Patient Safety and Medical Management (PSMM) and as such is a member of the PSMM Leadership Team

 

As the EEA QPPV you will hold an executive position with the objective of fulfilling the legal requirements of the EEA QPPV as defined by prevailing European legislation and also ensure that UCB operates in accordance with Pharmacovigilance EEA regulatory standards and that compliance risks are identified and mitigated.

 

You will work in environment that is defined by Legal Framework/Authority

  • The EEA QPPV is responsible for the establishment, maintenance, compliance and continuous improvement of UCB’s pharmacovigilance system in accordance with the legal framework for pharmacovigilance of medicinal products for human use in the EU given by the Regulation (EU) No 1235/2010 amending Regulation (EC) No 726/2004, by the Directive 2001/83, as amended in 2010 by Directive 2010/84/EU, as well as by the Commission Implementing Regulation (EU) N° 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities and in the associated guidelines of good pharmacovigilance practices (GVP)
  • At UCB, The EEA QPPV has oversight and exercises authority over the functioning of the Pharmacovigilance system in all relevant aspects, including its quality system, the EEA QPPV is a member of the following UCB Governance Bodies:
    • Pharmacovigilance Quality Council (PVQC)
    • Global Labeling Committee (GLC)
    • Benefit-Risk Board (BRB)
    • Individual Case Safety Report (ICSR) Quality Forum (IQF)
    • Recall Committee
    • Patient Safety (PS) Portfolio Governance Committee


You will contribute by focusing on the following main accountabilities:

  • Shall act as the single PV contact point for the national competent authorities and the Agency on a 24-hour basis and as a contact point for PV inspections
  • Shall be accessible continuously and when unavailable will nominate a back-up
  • Shall lead the network of other local QPPVs to ensure sharing of information and expertise
  • In relation to the PV system, is responsible for the establishment and maintenance of the UCB PV system in accordance with the legal framework for PV of medicinal products for human use in the EEA – supported by the PV Excellence team
  • In the EEA, this implies that the EEA QPPV shall:
    • have the authority to influence the performance of the company PV system and its related quality system in order to promote, maintain and improve compliance with the legal requirements
    • have oversight over the functioning of the PV system in all relevant aspects including the PSMF and the PV quality system
    • have an additional dotted line reporting to the Global Head of Internal Audit.  With this connectivity a Pharmacovigilance Auditing Committee occurs to provide top-line visibility of the PVQA risk assessments, audit plans, audit execution and CAPAs
  • In relation to the products for which UCB holds a marketing authorization in the EEA, specific responsibilities of the EEA QPPV include those described in GVP Module I and the maintenance of the overview on the specific tasks that are delegated
  • Understand the direction of travel of EU Authorities and enable UCB to proactively align with regulatory expectations
  • Support ongoing evolution of the PV system to prepare for the future by ensuring appropriate prioritisation of activities by a pragmatic approach balancing acceptable risk taking and effective targeting of available resources
  • Influences external environment and develops a strong within industry and regulators acts proactively as a UCB representative within external organizations (e.g. patient interest groups, industry trade associations, congress etc.)
  • Demonstrates integrity in decision making and builds trust inside and outside UCB

 

Back-up

  • Shall ensure that the deputy QPPV has all necessary information to fulfill the role, and that the 24 hour contact details of the EEA QPPV and deputy QPPV have been notified to all regulatory authorities in which marketing authorizations are held within their respective territories and to the Agency.


Interested? For this position you’ll need the following education, experience and skills:

  • A Medical Degree
  • At least 15 years’ experience within the Pharma Industry (medical or clinical development) with at least 8 years of experience in pharmacovigilance  
  • A strong focus on the patient in all decision making
  • Technical knowledge of EEA PV requirements and their implementation vs international requirements and in-depth knowledge of European regulations
  • Solid scientific/medical: Shall be highly qualified profile in PV and related matters such as medicine, pharmaceutical sciences as well as epidemiology, biostatistics, data integrity etc.
  • Pragmatic and Prioritization mindset to effectively balance risks in context of reality
  • Leadership skills
  • Leadership and decisiveness- ability to delegate, to choose the tasks and the levels of supervision that can be delegated,
  • Should be a central agent who assumes a lead role in PV and share experience and challenges with UCB local QPPVs (maybe a dotted line?)
  • Resilience and Patience
  • Excellent communication skills. strong communication skills & negotiating skills
  • Demonstrates integrity and inspires trust (internally and externally)
  • Has a long term vision for PV (for products authorized in the EEA) in the globalisation environment

 

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

 

In PSMM we have an experienced and committed leadership team who focus on the people in the team as well as the delivery of the strategic objectives. This means we have a very strong team who are supportive and collaborative who enjoy working together.

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.

About us.

UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. 

Source: UCB