25 Emplois pour Médical - Belgique

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at **Job Function:** Medical Affairs Group **Job Sub** **Function:** Medical Affairs **Job Category:** Scientific/Technology **All Job Posting Locations:** Brussels, Brussels-Capital Region, Belgium, CZ005 Walterovo Namesti, DK005 Copenhagen, Dublin, Ireland, FI001 Espoo, FR015 Rungis, GB019 Bessemer, GB025 ACT London, UK, IE006 Airton, IE009 Janssen Cilag Ltd, IT002 Milano, IT004 Pratica di Mare Pomezia, Limerick, Ireland, London, United Kingdom, Milano, Italy, NL017 Roden, NO001 Oslo, Paris, Île-de-France, France, Pomezia, Roma, Italy, SE007 Stockholm **Job Description:** This position, as part of Medical Affairs team, supports, Intraocular Lenses (IOLs) proctoring and Medical Information requests (MIR), in order to ensure consistent and optimum clinical outcomes. Provides outcomes and sub optimal results' analysis to optimize the use of J&J products including clinic workflow, patient pre management, pre & post operative checks and all related factors that have an influence on final patients' outcomes. **Key Responsibilities** + IOLs' case analysis and calculation, focus on PCIOLs, included in approved J&J Training programs and following IOL Calculation processes. + Manage MIR, providing clinical responses and HCP's guidance according to J&J VISION policies, messaging and processes in a timely manner (<4days). + Generate MIR statistics´ reports including queries and complaints to effectively supervise products´ clinical performance in close collaboration with all related partners (Product Safety, Marketing, R&D and Commercial) + Assist HCPs with post-operative outcomes analysis, providing optimization and problem-solving support at sites experiencing sub-optimal results. + Provide clinical expert level support to external and internal J&J customers with focus on NPIs (New Product Introduction). + Support Demos and Clinical Studies as required. **Qualifications and Requirements** Minimum education required: + Degree in Optometry or similar education in Ophthalmology + Min. 5 years of clinical and surgical ophthalmic background Minimum experience (number of month/years and type of work experience beyond formal education) required: + 2-4 years in practical experience in clinical environment, e.g. in ophthalmic surgical centers or hospitals and/or with experience in the management of Cataract patient. + IOLs Subject matter expertise, analytic mindset, high and detailed knowledge of products and respective clinical experience + Good presentation and communication skills towards decision makers + Excellent problem-solving and analytics skills, service oriented + Ability to work independently with minimal supervision. + Flexible toward management and customer needs regarding work scheduling. + Training and/or teaching experience preferred. + Fluent English and French required. + Other languages valued (Italian) **Position Accountability / Scope** + Direct report to Associated Director Clinical Services, Medical Affairs + No budget responsibility + Home-office based with up to 20% traveling time due to congresses, workshops, internal/external training duties and/or face-to-face medical doctor consultation. + This position is open to multiple locations within the EMEA region

Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
Join AbbVie as a Medical Science Liaison - Parkinson's Disease
This field-based medical role is centered on scientific engagement with key external stakeholders, including healthcare professionals, researchers, payers, and providers. As an MSL, you will play a critical role in building trusted relationships with Tiered External Experts within the Parkinson's therapeutic area and across your assigned geographic region.
Your mission is to support their scientific and clinical needs, share relevant insights, and contribute to AbbVie's commitment to advancing care in neurodegenerative diseases.
+ Provide scientific and technical leadership to ensure professional and credible relationships with thought leaders and external experts of strategic importance to AbbVie.
+ Assist in the initiation, oversight and follow up of assigned clinical studies and medical projects initiated within the therapeutic area for which the MSL carries responsibility (e.g. post marketing clinical activities such as registry/database projects, epidemiological surveys, post-authorization studies (phase IV, .)
+ Serve as a point of contact within the Medical Affairs team for thought leaders and external experts within an assigned geographic area to satisfy their needs for scientific knowledge in a therapeutic area and, when requested, relevant AbbVie medicines, to support their safe, effective and appropriate use. Use available communication channels including digital channels to optimize scientific communication with EE, based on their educational needs.
+ Upon request, assist physicians with requests for access to AbbVie medicines on early access programs, subject to all applicable legal and regulatory requirements.
+ Deliver credible presentations on scientific matters to physicians, individually or in groups (meetings, clinical sessions, etc.), where requested.
+ Provide key thought leaders / external experts and internal medical and clinical teams with scientific and technical support for publications of scientific or medical interest.
+ Support internal teams such as sales and marketing and members of the Affiliate Brand Team to develop their scientific and technical expertise through the delivery of scientific update presentations.
+ Work collaboratively and cross-functionally with other in-field members while retaining functional independence.
+ Facilitate medical and scientific field intelligence - for example, competitor research and medical strategies, educational activities - and communicate, where appropriate, within the Company. You detect signals from external experts and translates these into insights, opportunities/threats for the company.
+ Attend relevant scientific meetings and Conferences. Collaborate with internal stakeholders to develop summaries of key data and other scientifically relevant information to inform AbbVie strategic priorities and initiatives.
+ Supportive collaboration with Clinical Research, development team and Real World Evidence team to facilitate successful set up of studies and support related recruitment.
+ Developing and maintaining expertise in specific relevant therapeutic area, attending scientific society meetings and local, global scientific medical meetings
+ Developing preliminary contacts in EEs and identifying UMN in specific disease, gaining scientific expertise to support market access and pre-launch internal activities.
+ Plan field activity and EE engagement plans using optimally the tools provided (Veeva, SIP, SCL, Dashboards.) aligned with Playbook requirements. Ensure excellence in field activity execution, reporting and follow up
Qualifications
+ Master degree in a relevant scientific discipline is required and demonstrated experience in Medical Affairs will be considered.
+ Experience in Neurosciences and particularly in Parkinson disease is a plus.
+ Experience in developing and maintaining expert knowledge for a therapeutic area, and in medical research in general.
+ Dynamic and proactive with growth mindset
+ Experience in developing networks with External Experts, partnering with hospital clinical teams for a better patient outcome.
+ Knowledge of the pharmaceutical environment and the role of Medical Affairs to advance the medical and scientific objectives of a pharmaceutical company.
+ Knowledge in the scientific methods applied to clinical research and current legislative/regulatory controls applicable to this research.
+ Ability to comprehensively learn about new subject areas and environments.
+ Excellent written and spoken communication and presentation skills, with a demonstrated ability to develop and maintain strong collaborative relationships with thought leaders, physicians and other healthcare decision makers.
+ Demonstrated ability to organize, strong project management and planning skills and capability to prioritize and work effectively in a constantly changing environment
+ High Customer orientation
+ Proficiency in Dutch, French, English
+ Team player - strong collaboration with other infield team members
+ Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
Additional Information
Competencies Ways we Work
- All4OneAbbvie - Interpersonal Savvy
Relates well to all kinds of people, up, down, and sideways, inside and outside the organization; builds appropriate rapport; builds constructive and effective relationships; uses diplomacy and tact; can diffuse even high-tension situations comfortably.
- Decide Smart&Sure - Dealing With Ambiguity
Can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isn't upset when things are up in the air; doesn't have to finish things before moving on; can comfortably handle risk and uncertainty.
- Agile&Accountable - Managing Vision and Purpose
Communicates a compelling and inspired vision or sense of core purpose; talks beyond today; talks about possibilities; is optimistic; creates mileposts and symbols to rally support behind the vision; makes the vision shareable by everyone; can inspire and motivate entire units or organizations.
- Clear&Courageous - Managerial Courage
Doesn't hold back anything that needs to be said; provides current, direct, complete, and "actionable" positive and corrective feedback to others; lets people know where they stand; faces up to people problems on any person or situation (not including direct reports) quickly and directly; is not afraid to take negative action when necessary.
- Make Possibilities Real - Planning
Accurately scopes out length and difficulty of tasks and projects; sets objectives and goals; breaks down work into the process steps; develops schedules and task/people assignments; anticipates and adjusts for problems and roadblocks; measures performance against goals; evaluates results.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

You ensure for the Medical Director and Medical Affairs leadership team, the smooth execution of operational, financial, and compliance-related processes across the Medical department.
This role drives medical excellence and operational efficiency by managing critical workflows and enabling cross-functional alignment.
**Responsibilities**
+ Work with the medical leadership team and global teams to implement medical metrics, processes and learning initiatives, incorporating AI and digital tools to boost efficiency and impact.
+ Ownership of ordering process for Medical Need Programs & Compassionate Use: ensure correct request handling & processing (quality & regulatory requirements, product supply), ensure clear communication with external stakeholders on required administration and status of the request, ensure accurate internal tracking & documentation in line with regulatory requirements.
+ Drive Grants & Donations process: manages requests, supervises due diligence process by internal stakeholders, organizes G&D review committee, communicates decisions to internal & external stakeholders, supervises administration in line with legal & compliance requirements, tracks milestones & ensures reporting of progress by external stakeholders.
+ Provide admin and logistics support for Medical Events with external focus, e.g. congresses, off-site/teambuilding activities, cross-country meetings. Manage vendor onboarding, and contract setup and FU.
+ Drive continuous process improvement initiatives across medical affairs team.
+ Ensure operational excellence in medical affairs team: coordinate the onboarding of new hires and manage distribution lists, organizational charts, yearly medical journal subscriptions, external memberships and SharePoint updates.
+ Manage invoices, PO's, accruals, DOE decks and budget updates
+ Supervise activities (eg POs, contracts, C3 records with capability center) to ensure compliance with legal and procedural requirements, and audit-readiness at all times
+ Function as back-up for peers in periods of absence, e.g.: FU on sample requests, POC for external medication information vendor team, reception phone coverage through rotation
**Qualifications & requirements**
+ Min bachelor degree or equivalent through experience
+ Min 3-5 years experience in a project mgt role
+ Strong organizational and analytical skills
+ Analytical mindset, detail-oriented - Ability to create dashboards
+ Must have good oral and written communication skills
+ Multilingual preferred (English, Dutch, French)
+ Proficiency in relevant software: Excel, Outlook, Word, Power Point, SAP, Microsoft project, .
+ Previous experience in the pharmaceutical industry is a plus
+ Some scientific knowledge is a plus
+ Balances multiple priorities under time pressure
+ Service-oriented, proactive in solving process issues
+ Team player, adaptable to change

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Discover Impactful Work:**
The (Associate) Medical Director will provide medical support and medical advice for clinical trials and safety evaluation within the Pharmacovigilance department.
**A day in the Life:**
+ Provide medical leadership to the study teams, including creating clinical trial protocols while implementing the latest scientific information, contribute to site selection, involved in review and approval of study protocols and amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions and other clinical documents as required for the conduct of clinical trials
+ Real time Medical Monitoring of clinical studies: ensure medical validity of each individual primary endpoint as well study subject safety, while ensuring medical issues are identified early. Pro-active customer concern and correction of issues in consultation with the Global Medical Indication Lead
+ During initial review of protocol, consults with internal groups and support staff regarding procedural and budgetary items and the necessity for change due to any subsequent protocol amendments. Acquires other functions' dedication to close gaps and address issues timely and effectively. Serves as chief liaison between sponsor and all PPD, part of Thermo Fisher Scientific internal departments performing the required tasks during all study phases. Educates Investigator sites by delivering a protocol specific lab procedures presentation and demonstration during an investigator meeting. Controls, handles and follows day to day activities during the course of the clinical trial to resolve any issues and answer queries
+ Medical point of contact for all internal and external stakeholders: Interact with the investigators as needed, answer questions of IRBs and Health Authorities, prepare and present material to the study executive and independent safety committee if applicable; medical training of site staff at Investigator meetings; CRA training in new indications
+ Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP
+ Closely collaborate with the cross functional study team members in order for medical risks, issues, and results to be clear to all involved parties
**Education**
+ MD, MB/BS or equivalent degree and strong medical knowledge, shown clinical experience running Neurology patients in hospital practice.
+ Epileptology experience would be an advantage
**Knowledge, Skills, Abilities**
+ Significant experience within pharmaceutical industry, clinical trials and pharmaceutical medicine is critically important
+ Is fluent in spoken and written English
+ Shown understanding and experience with NDA submission process.
+ Shown understanding of regulatory guidelines for adverse event reporting
+ Strong communication & presentation skills and is a strong teammate
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today! Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**Medical Advisor (Field Based Medical/FBM) Immunology Pipeline**
+ _Location: Sweden, Denmark, Belgium, Netherlands_
+ _Hybrid field role executing on the medical strategy (incl. omnichannel engagements) with a primarily focus on the external environment._
+ _Job type: Permanent, Full time_
**About the job**
This position will report to the North Europe Medical NextGen Immunology team, which is a segment of the Medical Specialty Care Organization. In this strategically important role, you will drive Medical Affairs initiatives for Sanofi's immunology pipeline in Northern Europe, with a primary focus on respiratory indications, and additional contributions in rheumatology and gastroenterology. The scope will evolve in alignment with pipeline progression. This is a field-based position with travel required across the region. The North Europe Medical NextGen Immunology team is proud to support Sanofi's deep commitment to chasing the miracles of science to improve the lives of patients.
This position reports to the Immunology Pipeline Lead, North Europe, Next Gen Immunology.
Medical advisors (FBM - field based medical) are the extension of the medical function in the field. They build and develop enduring 'win-win' relationships with healthcare professionals and institutions, creating constructive partnerships with internal and external stakeholders to disseminate scientific information and generate insights. As Medical Advisors (FBM) Immunology Pipeline you provide field medical support that is aligned and integrated to the overall medical strategy within the BU. Medical advisors execute the medical and scientific (non-promotional) strategy for North Europe fully aligned with the MCO medical and cross functional strategy. They are a trusted source of scientific and medical information for North Europe.
**About Sanofi:**
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
**Main responsibilities:**
+ Provide study site support and accelerate patient recruitment via scientific exchange.
+ Engages proactively and reactively with healthcare professionals and institutions in an omnichannel manner.
+ Engages external stakeholders on medical and scientific information exchange for the therapeutic area during one-to-one interactions and group settings.
+ Organises and engages KOLs & HCPs during local group scientific meetings (hospital staff meetings, webinars, etc) according to the Stakeholder Engagement plan, aligned with Country/MCO Medical plan.
+ Develops and maintains trusted partnerships, through scientific engagement and exchange, with healthcare professionals and institutions in a rapidly evolving healthcare environment.
+ Communicates the clinical value of the TA products to population-health/formulary decision makers (as applicable).
+ Provides high-quality, accurate, balanced and directed information to key external stakeholders in response to unsolicited requests for information, supports investigators in IIR submissions, management of local advisory boards.
+ Develops and executes the individual stakeholder engagement plans, aligned with the Medical Plan.
+ Generates high-value, actionable insights and proposes solutions.
+ Contributes to / manages evidence-generation activities, supporting both internal evidence-generation projects and IISs.
+ Contributes to the development of market access dossiers and provides the medical specific input to the dossier.
+ Collaborate with cross-functional teams to achieve common goals.
+ Collaborate with the North Europe Next Gen medical team and Clinical Studies Unit to support clinical trials.
+ Internal governance and strategy: Overseeing the approval of medical and marketing materials, and contributing to the development of country medical strategy
+ Collaborates effectively with relevant internal stakeholders while maintaining full compliance with company, industry, legal and regulatory requirements.
+ Contribute to a culture of innovation by proposing novel solutions to improve processes and outcomes.
**About you**
**Education** :
+ MD, Pharmacist/PharmD, PhD or Master of Science degree (required).
**Experience** :
+ Work Experience: Preferably 1-year previous MSL experience and/or clinical / industry experience.
+ Ability to cultivate and maintain strong relationships with KOLs, healthcare professionals, and other stakeholders.
+ Data gathering/study related experience, experience with market access/HTA dossiers. Experience of product launches is considered an advantage.
+ Respiratory/Allergy/Pulmonary and/or Gastroenterology/Rheumatology/Immunology experience preferred.
**Languages** :
+ Intermediate level in spoken and written business English (required).
+ Local language skills considered an advantage.
**Technical skills** :
+ Ability to interpret key scientific data and translate this information to meet educational and research needs.
+ Utilizes effective, professional communications to cultivate strong working relationships with internal partners and external stakeholders.
+ Exemplary presentation skills with the ability to distil complex data into a simple and impactful story.
+ Use of CRM tools.
+ Country market access framework.
**Soft skills** :
+ Proactive Problem-Solver: Anticipates challenges and proactively develops solutions. Demonstrates flexibility in addressing unexpected issues and opportunities.
+ Resiliency: Demonstrates perseverance in the face of setbacks. Views challenges as opportunities for growth and learning and inspires the same mindset in colleagues.
+ Ability to foster a positive and inclusive culture.
+ Strategic thinking.
+ Business acumen.
+ Interpersonal relationship.
+ Transversal collaboration.
+ Learning agility.
+ High level of communication (written and verbal).
**Pursue progress, discover extraordinary**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
#LI-EUR
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
Global Terms & Conditions and Data Privacy Statement ( is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting or via our movie We are Sanofi ( an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (

**Job Title: Instrument/Medical Device Validation Specialist**
**Location: Belgium**
**Project Overview:**
TFS is seeking experienced Instrument Validation Specialists to support a critical initiative focused on validating software installed on laboratory instrumentation in accordance with EMA guidelines.
These resources will work alongside their internal FTE team to ensure compliance, documentation accuracy, and alignment with PPD IT software management SOPs.
**Key Responsibilities:**
-Document and validate software installed on lab instruments per EMA regulatory standards.
-Migrate instrument software management to align with PPD IT SOPs.
-Capture and document software requirements and configurations.
-Develop validation test cases and protocols related to Instruments/Medical devices validation.
-Create infrastructure and data flow diagrams.
-Conduct comprehensive risk assessments.
-Collaborate with cross-functional teams including IT, QA, and lab operations.
**Required Skills & Qualifications:**
-Proven experience in Instrument/Medical device validation within a regulated (GxP) environment.
-Strong technical writing skills for documentation and test case development.
-Excellent communication skills to interact with cross-functional teams.
-Highly detail-oriented with a focus on compliance and accuracy.
-Familiarity with EMA guidelines and IT SOPs in pharmaceutical or medical device settings.
-Experience with risk assessment methodologies and validation lifecycle documentation.
**Preferred Experience Levels:**
-Mid to Senior Level professionals with 6-10+ years of relevant experience.
-Prior experience in lab instrumentation software validation is highly desirable.
Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

**Job Title: Instrument/Medical Device Validation Specialist**
**Location: Belgium**
**Project Overview:**
TFS is seeking experienced Instrument Validation Specialists to support a critical initiative focused on validating software installed on laboratory instrumentation in accordance with EMA guidelines.
These resources will work alongside their internal FTE team to ensure compliance, documentation accuracy, and alignment with PPD IT software management SOPs.
**Key Responsibilities:**
-Document and validate software installed on lab instruments per EMA regulatory standards.
-Migrate instrument software management to align with PPD IT SOPs.
-Capture and document software requirements and configurations.
-Develop validation test cases and protocols related to Instruments/Medical devices validation.
-Create infrastructure and data flow diagrams.
-Conduct comprehensive risk assessments.
-Collaborate with cross-functional teams including IT, QA, and lab operations.
**Required Skills & Qualifications:**
-Proven experience in Instrument/Medical device validation within a regulated (GxP) environment.
-Strong technical writing skills for documentation and test case development.
-Excellent communication skills to interact with cross-functional teams.
-Highly detail-oriented with a focus on compliance and accuracy.
-Familiarity with EMA guidelines and IT SOPs in pharmaceutical or medical device settings.
-Experience with risk assessment methodologies and validation lifecycle documentation.
**Preferred Experience Levels:**
-Mid to Senior Level professionals with 6-10+ years of relevant experience.
-Prior experience in lab instrumentation software validation is highly desirable.
Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

**Job Title: Instrument/Medical Device Validation Specialist**
**Location: Belgium**
**Project Overview:**
TFS is seeking experienced Instrument Validation Specialists to support a critical initiative focused on validating software installed on laboratory instrumentation in accordance with EMA guidelines.
These resources will work alongside their internal FTE team to ensure compliance, documentation accuracy, and alignment with PPD IT software management SOPs.
**Key Responsibilities:**
-Document and validate software installed on lab instruments per EMA regulatory standards.
-Migrate instrument software management to align with PPD IT SOPs.
-Capture and document software requirements and configurations.
-Develop validation test cases and protocols related to Instruments/Medical devices validation.
-Create infrastructure and data flow diagrams.
-Conduct comprehensive risk assessments.
-Collaborate with cross-functional teams including IT, QA, and lab operations.
**Required Skills & Qualifications:**
-Proven experience in Instrument/Medical device validation within a regulated (GxP) environment.
-Strong technical writing skills for documentation and test case development.
-Excellent communication skills to interact with cross-functional teams.
-Highly detail-oriented with a focus on compliance and accuracy.
-Familiarity with EMA guidelines and IT SOPs in pharmaceutical or medical device settings.
-Experience with risk assessment methodologies and validation lifecycle documentation.
**Preferred Experience Levels:**
-Mid to Senior Level professionals with 6-10+ years of relevant experience.
-Prior experience in lab instrumentation software validation is highly desirable.
Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

**Job Title: Instrument/Medical Device Validation Specialist**
**Location: Belgium**
**Project Overview:**
TFS is seeking experienced Instrument Validation Specialists to support a critical initiative focused on validating software installed on laboratory instrumentation in accordance with EMA guidelines.
These resources will work alongside their internal FTE team to ensure compliance, documentation accuracy, and alignment with PPD IT software management SOPs.
**Key Responsibilities:**
-Document and validate software installed on lab instruments per EMA regulatory standards.
-Migrate instrument software management to align with PPD IT SOPs.
-Capture and document software requirements and configurations.
-Develop validation test cases and protocols related to Instruments/Medical devices validation.
-Create infrastructure and data flow diagrams.
-Conduct comprehensive risk assessments.
-Collaborate with cross-functional teams including IT, QA, and lab operations.
**Required Skills & Qualifications:**
-Proven experience in Instrument/Medical device validation within a regulated (GxP) environment.
-Strong technical writing skills for documentation and test case development.
-Excellent communication skills to interact with cross-functional teams.
-Highly detail-oriented with a focus on compliance and accuracy.
-Familiarity with EMA guidelines and IT SOPs in pharmaceutical or medical device settings.
-Experience with risk assessment methodologies and validation lifecycle documentation.
**Preferred Experience Levels:**
-Mid to Senior Level professionals with 6-10+ years of relevant experience.
-Prior experience in lab instrumentation software validation is highly desirable.
Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.