OPEN POSITIONS

JOB DESCRIPTION

We are are hiring a full time HR Manager at Accelsiors, Hungary. A great opportunity to join us! This is a global role, including Europe, US, India, MENA countries (aprox 200 employees). Reporting to CEO.

Job components:

• support the organization in achieving its objectives by developing and implementing human resource (HR) strategies that are integrated with the business strategy (strategic HRM)
• contribute to the development of a high-performance culture
• ensure that the organization has the talented, skilled and engaged people it needs
• ensure effective system for performance measurement and appraisal process
• ensure a motivating reward and incentive system
• create a positive employment relationship between management and employees and a climate of mutual trust;

Core Competencies:

• organizing and planning
• problem analysis and problem solving
• judgment skills
• critical thinking skills
• communication skills
• presentation skills
• integrity
• coaching skills
• persuasive ability
• adaptability

Requirements:

• Bachelor degree in relevant area
• HR Master preferred
• 5+ years’ experience in pharmaceutical/CRO industry
• International exposure
• Experience in human capital management
• High Proficiency in English.

Location: Office based position in Budapest, Hungary.

Employment-Type: Full-time, permanent

What to expect next:

If you are interested in the position, please click on the button below and send us your CV in English via our online application form. A member of our recruitment team will review your qualifications and if interested, you will be contacted for an interview.

JOB DESCRIPTION

We are are hiring a full time Quality Assurance Auditor at Accelsiors. A great opportunity to join us! Working within the QA team with minimum supervision to ensure that the quality of the research or post approval activities conducted by the organisation is maintained. The QA Auditor is responsible for all types of audit including project-specific, system/process and vendor audits. Responsible for facilitation of complex issue investigation e.g. serious quality issues (SQIs). Ensuring that quality targets are met and relevant actions are executed as required. To act as the QA representative for assigned Accelsiors projects and GCP or equivalent Subject Matter Expert.

Essential Job Functions:

• Conducts internal and external audits of documentation, sites, databases, reports, processes and systems to ensure compliance with SOPs and applicable guidelines/regulations
• Effectively documents audit observations, reports the findings of audits and provides advice on resolving problems identified
• Prepares investigational sites and Accelsiors facilities for inspection by regulatory authorities
• Leads SQI investigations and client audits
• Trains Accelsiors staff on current GCP, and other regulatory requirements, SOP and QA requirements
• Acts as QA project manager for assigned projects
• Conducts reviews of Accelsiors controlled documents, developes new, and reviews existing QA procedures
• Manages the Accelsiors Quality Management System
• Facilitates and manages Client’s Audits/Evaluations or Regulatory Inspections
• Supports business development colleagues to provide input into proposals which include QA activities
• Acts as a GCP/quality subject matter expert and advisory resource in support of Accelsiors operational needs

We ideally require:

• BSc degree (or equivalent) as a minimum, Scientific Discipline/Life Sciences area preferred
• Thorough knowledge of GCPs, related directives/regulations, quality systems, audit procedures, reporting
• At least 2 years experience in GCP/GMP/GLP Quality Assurance with proven Investigational Site and Vendor Auditing experience
• Fluent in English, written and spoken
• Good problem-solving skills
• Must demonstrate excellent computer skills
• Capable of writing Quality Management Documents, effective SOPs, Quality Assurance Reports and Training materials
• Position requires up to 30% travel

Location: Availability for home based position in Central or Eastern Europe. We would be happy to discuss the company and role in more detail upon application.

Employment-Type: Full-time, permanent

What to expect next:

If you are interested in the position, please click on the button below and send us your CV in English via our online application form. A member of our recruitment team will review your qualifications and if interested, you will be contacted for an interview.

JOB DESCRIPTION

We are looking to hire full time Clinical Research Associates (CRA) at Accelsiors. A great opportunity to join us! Acts as primary individual responsible for monitoring activities with investigational sites, from site identification and selection, through site activation, subject enrolment and study conduct until close out, ensuring the clinical trial is conducted in compliance with study protocol and procedures, ICH-GCP guidelines and any applicable regulations and SOPs.

Requirements:

• Bachelor’s degree in health care or life science related field
• At least 2 years proven monitoring experience
• Strong knowledge of ICH GCP Guidelines and other applicable regulatory requirements
• Fluent in written and spoken English
• Proven ability to work independently in a fast-paced environment
• Strong communication, interpersonal, and organizational skills
• Must demonstrate excellent computer skills
• Willing to travel approximately 40-60% nationally

Location of job:

Availability for home based positions. We would be happy to discuss the company and role in more detail upon application.

Employment Type: Full-time, permanent.

What to expect next:

If you are interested in the position, please click on the button below and send us your CV in English via our online application form.
A member of our recruitment team will review your qualifications and if interested, you will be contacted for an interview.

JOB DESCRIPTION

We are hiring a Regulatory Affairs Manager at Accelsiors, Serbia. Supporting the Senior Regulatory Affairs Managers by adhering to local regulatory requirements, applicable country specific laws and orders, not only during the application period in countries concerned by the clinical trial, but during the whole life cycle of the clinical trial as well, ensuring in this way that the regulatory compliance is met and that Accelsiors effectively works with Sponsors, Sponsor’s Vendors and Accelsiors Subcontractors.

Essential Job Functions:

• Manages the regulatory aspects of the study with regard of fulfilling the regulatory requirements. Perform all duties, under the direction of the Director Regulatory Affairs
• Serves as a secondary point of contact for Sponsor and will liaise with local Regulatory Authorities, IRB/IEC, and Principal Investigator or Sponsor as necessary
• Coordinates the submission process. Tracks and communicates status and progress of the regulatory component of the project to the project team. Responsible for preparation of authorizations needed from Sponsor, which are in accordance with local requirements.
• Uses expertise to identify potential issues and risks specific to the Regulatory Affairs
• Manages and coordinates the Regulatory Affairs Associates in regards of fulfilling the regulatory obligations during the life cycle of the projects
• Contributes to finalization of Scope of Work (SOW) for Regulatory Affairs (with Regulatory Affairs Manager, Project Manager and Sponsor)
• Assisting the Senior Regulatory Affairs Manager with the development and management of the Regulatory Management Plan.
• Creates and reviews the Standard Operating Procedures.
• Implements and maintains good communication network
• Assures that the conduct of the trial is in accordance with the currently approved protocol/amendment(s), SOPs, GCP/ICH Guidelines, and other applicable country – specific regulatory requirements

Requirements:

• Bachelor’s level degree in life sciences, pharmacy or nursing (also with higher degree)
• Strong knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Proven ability to work independently in a fast-paced environment
• Strong leadership, communication, interpersonal, and organizational skills
• Must demonstrate excellent computer skills
• Ability to provide clear direction and guidance to others
• Position requires up to 30% travel
• Time requirements: at least 2 years of working experience in total

Location of job:

Office based position with a preferred location in Novi Sad,or availability for home based position in Serbia. We would be happy to discuss the company and role in more detail upon application.

Employment Type: Full-time, permanent position

What to expect next:

We look forward to receiving your application (in English).
A member of our recruitment team will review your qualifications and if interested, you will be contacted for an interview.

JOB DESCRIPTION

We are looking to hire an Executive Assistant, to work as Receptionist. This is a full time, permanent position, office-based in Budapest HQ. Start date immediately. A great opportunity to join us!

Responsibilities:

• prepare and edit correspondence, communications, presentations and other documents
• file and retrieve documents and reference materials
• conduct research, assemble and analyse data to prepare reports and documents
• manage and maintain executives schedules, appointments and travel arrangements
• arrange and coordinate meetings and events
• monitor, respond to and distribute incoming communications
• answer and manage incoming calls
• receive and interact with incoming visitors
• interact with external clients
• any other task delegated by Line Manager
• general clerical duties including photocopying, fax and mailing
• maintain electronic and hard copy filing system
• retrieve documents from filing system
• schedule and coordinate meetings, appointments and travel arrangements for managers or supervisors
• open, sort and distribute incoming correspondence
• maintain office supply inventories
• coordinate maintenance of office equipment
• ensure security and confidentiality of data
• design and implement office policies and procedures

Requirements:

• High school education minimum
• Strong English language skills
• Financial knowledge would be appreciated
• knowledge of standard office administrative practices and procedures
• computer skills and knowledge of relevant software
• knowledge of operation of standard office equipment
• knowledge of principles and practices of basic office management

Core competencies:

• organizational and planning skills
• communication skills
• information gathering and information monitoring skills
• problem analysis and problem solving skills
• judgment and decision-making ability
• initiative
• confidentiality
• attention to detail and accuracy
• flexibility
• adaptability
• customer service orientation
• teamwork

Location of job: 1222 Budapest, Hungary

Employment Type: Full-time, permanent position

What to expect next:

We look forward to receiving your application (in English).
A member of our recruitment team will review your qualifications and if interested, you will be contacted for an interview.

JOB DESCRIPTION

Associate Director, Biostatistics oversees the statistical activities within the whole Biostatistics department, ensuring the timely and correct preparation of all statistical deliverables for each project. Supervises the correctness of methodologies applied by all biostatisticians working under his/her guidance. May act as a project statistician as well. Mentors younger statisticians. Learns and implements new statistical methodologies if needed.

Requirements:

• Master’s level degree in statistics, life sciences or IT related field.
• Minimum 5 years working experience in clinical biostatistics (pharma company or CRO).
• Minimum 3 years experience in SAS
• Must have a comprehensive understanding of theoretical and applied statistics, and methods of analysing clinical study data.
• Must be fully aware of Good Clinical Practice/ICH Guidelines and other regulatory guidelines in a pharmaceutical research setting and experience in clinical trials.
• Strong team contributor with effective leadership abilities.
• Ability to understand new clinical study designs, to address research questions
• High level English knowledge (written and spoken)

Location of job:

Flexible location. We would be happy to discuss the company and role in more detail upon application.

Employment Type: Full-time, permanent

What to expect next:

We look forward to receiving your application (in English).
A member of our recruitment team will review your qualifications and if interested, you will be contacted for an interview.