Regulatory Affairs MDR

  • Location: Diegem
  • Type: Contracting
  • Job #19048

Regulatory Affairs MDR

Contracting – Flemish Brabant

Your responsibilities? 

With a good knowledge of Regulatory Affairs in the EU, this role will proactively coordinate and track the alignment of country-specific activities and liaise with relevant cross-functional stakeholders to support regulatory MDR Project deliverables for the BU.

Under moderate supervision and in accordance with all applicable federal, state and local laws/regulations, procedures and guidelines, this position:
 

  • Provides strategic guidance to the Business Unit related to regulatory requirements and develops recommendations pertinent to the Franchise in accordance with regulations and relevant guidelines
  • Ensures the timely execution of regulatory implementation activities and associated projects
  • Provides clear and timely communication of new and changing requirements to the Franchise regulatory teams
  • Educates Franchise Associates on EU requirements and integrating those requirements into Franchise procedures
  • Organizes and maintains reporting schedules, trackers and systems
  • Develops and sustains relationships with RA affiliates, contributing to the development and execution of local strategy. This includes planning, prioritization and preparation of responses to regulatory agencies' questions and other correspondence
  • Drives consistency across all businesses within the BU for technical documentation creation and adherence to procedures
  • Supports the creation of technical documentation for products within the portfolio to ensure continued knowledge, understanding of challenges and process improvements throughout the program
  • Supports the project plan and schedule to ensure all regulatory interdependencies are understood and accounted for in the overall schedule
  • Develops and maintains constructive and cooperative working relationships with business functions in the organization
  • Identifies and facilitates continuous improvement activities
  • Develops solutions to a variety of problems of extreme complexity in which data analysis requires an evaluation of intangible variables
  • Writes, reviews and revises company SOPs as required, recommending adjustments to processes to improve efficiency or align with compliance requirements
  • Responsible for communicating business related issues or opportunities to next management level
  • For those who supervise or manage staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

Your profile?

  • University degree in Science, Engineering, Technical or Biomedical field (or equivalent degree with adequate experience)
  • 6-8 years’ experience in Regulatory Affairs or other related discipline in the medical device or pharmaceutical industries
  • Good knowledge of medical device regulatory requirements in the EU
  • Ability to work effectively in a highly matrixed organization
  • Ability to work autonomously
  • Project Management Skills
  • Strategic thinking and ability to partner and influence key stakeholders
  • Highly skilled in establishing partnerships with Regional and Franchise colleagues
  • Strong communication, influencing and presentation skills
  • Strong results-orientated and sense of urgency
  • Strong ability to build constructive and cooperative working relationships
  • Excellent written and verbal communications skills in English (required) 

Our offer?

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.

You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Anaïs Malikian, [email protected]

Clinical Research Specialist

  • Location: Diegem
  • Type: Contracting
  • Job #18346

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team. 

Let's look together at your first challenge with us!

Clinical Research Specialist

The Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
Location: Diegem

Scope of work:

Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate procedures and guidelines, this position:

• Serves as a Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones, under supervision;

• Participates in the feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures;

• May serve as the primary contact for clinical trial sites (e.g. site management);

• Assists in the development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports);

• Supports applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed;

• Coordinates and executes ordering, tracking, and accountability of investigational devices and trial materials;

• Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel;

• Interfaces and collaborates with Clinical Research Associates (CRAs);

• Assists in overseeing and supports the development and execution of Investigator agreements and trial payments;

• Assists in clinical data review to prepare data for statistical analyses and publications;

• May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;

• May provide on-site procedural protocol compliance and data collection support to the clinical trial sites;

• Assists in tracking assigned project budgets;

• May act as Clinical Safety Coordinator (See ANNEX I – Clinical Safety Coordinator Duties and Responsibilities);

• May perform other duties assigned as needed;

• Is responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;

• Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;

• Should develop a strong understanding of the pipeline, product portfolio and business needs;

• Generally manages work with supervision. Independent decision-making for simple situations but requires guidance for complex situations.

Who are you?

Education

  • Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.

 

Experience

• BS with at least 2 years, MS and PhD with at least 1 year of relevant experience preferred.

• Previous experience in clinical research or equivalent is desired.

• Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).

• Clinical/medical background is a plus.

• Medical device experience is a plus.

 

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES & AFFILIATIONS

Functional and Technical Competencies:

• Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations;

• Proven track record in supporting clinical projects within clinical/ surgical research setting, on time, and in compliance to SOPs and regulations;

• Presentation and technical writing skills;

• Written and oral English communication skills.

 

Leadership Competencies:

Strong leadership required in alignment with intenal Leadership Imperatives:

• Connect – Develop collaborative relationships with key internal and external stakeholders.

• Shape – Actively participate in departmental process improvement activities.

• Lead – Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations.

• Deliver – Strive to ensure all deliverables on allocated studies are met on time, within budget and in compliance to SOPs and regulations.

 

LOCATION & TRAVEL REQUIREMENTS

• Primary location for this position is Diegem. At management discretion, the position may be performed remotely.

• Ability to travel approximately 20% depending on the phase of the program.

 

EXTERNAL INTERACTIONS

• Frequent (several times per month) interaction with physicians and research staff at centers selected for involvement in clinical research as well as those being evaluated.

• May have regular interaction with third party vendors supporting clinical studies as applicable per clinical trial.

 

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education. 

Clinical Research Manager

  • Location: Diegem
  • Type: Contracting
  • Job #18345

JJJP00011538

 

Description:

 

Clinical Research Manager (Clinical R&D)

JOB SUMMARY
This Clinical Research Manager will be responsible for clinical trial management within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

DUTIES & RESPONSIBILITIES
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
• Serves as a Clinical Research Manager within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones
• Has oversight of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures;
• Manages and oversees ordering, tracking, and accountability of investigational products and trial materials;
• Ensures applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed;
• Is responsible for team’s interface and collaboration with key opinion leaders, investigators, IRBs/ECs, Regulatory agencies, contractors/vendors, societies, associations and company personnel;
• Is responsible for clinical data review to prepare data for statistical analyses and publications;
• May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;
• Contribute to the development and delivery of appropriate Global EGS (Evidence Generation Strategies)/ EDS (Evidence Dissemination Strategies) to support New Product Development and Life-Cycle Management, with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc), ensuring cross-functional alignment;
• Ensures input and strong alignment from key regional Clinical R&D leads and other strategically important countries/ regions in the development of the EGS/ EDS;
• Leads in study design to develop appropriate clinical trials to meet the clinical evidence needs;
• May provide on-site procedural protocol compliance and data collection support to the clinical trial sites;
• Leads in appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, Abstracts, Manuscripts, Clinical Evaluation Reports, etc.;
• Is responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);
• Plans, tracks and manages assigned project budgets to ensure adherence to business plans;
• Contributes in clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc. including during sponsor regulatory inspections;
• Serves as the clinical representative on a New Product Development team;
• Is responsible for development of Post-Market Clinical Follow-up (PMCF) Plans and Reports;
• Conducts review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging;
• Is responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition;
• Manages and mentors resources assigned to designated clinical trials to provide quality deliverables while maintaining optimal efficiency;
• Is responsible for providing performance feedback to direct reports (if applicable) as well as coaching and assistance in their development;
• May perform other duties assigned as needed;
• Is responsible for communicating business related issues or opportunities to next management level. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
• Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;
• Should develop a strong understanding of the pipeline, product portfolio and business needs;
• Manages work independently. Independently solves problems arising during clinical trial execution, and will seek guidance for more complex problems, as needed.

EXPERIENCE AND EDUCATION
Education
• Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.

Experience
• A minimum of 8 years related scientific/ technical experience, including leadership/management role within Clinical Research.
• Significant previous experience in clinical project leadership across multiple studies/ programs is required.
• Experience working well with cross-functional teams is required.
• Experience with budget planning, tracking and control is required.
• Relevant industry certifications is preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).
• Clinical/medical background is a plus.
• A minimum of 1-2 year people management related experience is a plus.
• Medical device experience is highly preferred.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES & AFFILIATIONS
Functional and Technical Competencies:
• Thorough understanding of clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations;
• Ability to provide scientifically strategic and scientific clinical research input across New Product Development and Life-Cycle Management projects, including complex and/ or transformational projects;Proven track record in delivering clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations;
• Strong presentation and technical writing skills;
• Strong written and oral English communication skills;
• Comprehensive understanding of clinical trial regulations across multiple regions;
• Demonstrates competencies in the following area are required:
o Ability to lead teams to deliver critical milestones, including complex projects
o Strong project management skills with ability to handle multiple projects
o Strong people management skills
o Change agent in team development and progression

Leadership Competencies:
Strong leadership required in alignment with J&J Leadership Imperatives:
• Connect – Develop strong collaborative relationships with key internal and external stakeholders to ensure development and timely delivery of innovative EGS/ EDS. Create strong and productive partnership with resource providers and vendors.
• Shape – Make recommendations for and actively participate and lead in departmental process improvement activities. Through efficient use of resources, shape the way clinical trial management is conducted and resources are utilized.
• Lead – Continually develop expertise to provide strategic and scientific clinical research capability. Ensure appropriate escalation of compliance issues.
• Deliver – Ensure all deliverables on allocated studies and those of any direct reports are met on time, within budget and in compliance to SOPs and regulations. Ensure all sponsored studies have appropriately trained clinical trial leaders/ specialists assigned.

RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS
• Reports to Clinical Research Associate Director or Clinical Research Director
• Functions that this position is responsible for (direct/ indirect management):
o Clinical Study Administrator
o Clinical Research Specialist
o Senior Clinical Research Specialist
o Clinical Research Leader
• Expected to build collaborative relationships with key internal partners and stakeholders. Ref. duties and responsibilities section.

LOCATION & TRAVEL REQUIREMENTS
• Primary location for this position is Diegem.
• Ability to travel approximately 20-25% depending on the phase of the program.

EXTERNAL INTERACTIONS
• Interaction with physicians and research staff at centers selected for involvement in clinical research

Education Required  

Doctorate (PHD) or Equivalent

Job Function  

R&D

Job Subfunction  

Clinical Research MD

Site Access  

Off-Site with Site Access

Work Experience  

Generally Requires 8-10 Years Work Experience

Permanent Salary Equivalent Rate  

0,00

Regulatory Affairs Manager

  • Location: DIEGEM
  • Type: Contracting
  • Job #16120

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team. 

Let's look together at your first challenge with us!

Regulatory Affairs Manager

Our partners innovate to bring treatments to their patients that significantly improve their lives. Together with the government and other health partners they are working towards qualitative, affordable and accessible healthcare.

For our pharmaceutical partner in Diegem we are looking for a Regulatory Affairs Manager whereby you will be responsible in general for the managing of documents and dossiers. In addition to this, you will support clinical study submissions for early development projects. You will provide regulatory feedback on specific development topics and you will support in terms of documentation in systems.

Who are you?

  • You have a scientific degree in a life sciences related domain (BS/MS)
  • +/- 3 years of regulatory experience with basic regulatory knowledge of EU and US
  • Regulatory experience with projects in clinical development (clinical studies, and documentation related to IND/CTA submissions)
  • Experience in Big Pharma and understand that matrix (transversal collaboration, project teams etc)
  • Soft skills of most importance adapts quickly, flexible and embraces change, looks for solutions on own with some guidance, positive mindset, multitasking, honest/transparent

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education. For this project you have the possibility to work partially homebased.

 

Are you interested? Apply now by clicking on the orange button!