Regulatory Business Process Coordinator - PHARMA / RO-484

Status: 
closed
Location: 
4070 Basel
Start Date: 
2018-08-01
End Date: 
2019-07-31
Deadline: 
2018-07-19 11:30
Hours per day: 
8,00
Hours per week: 
40,00
Workload: 
100%
Total Hours: 
2.088
Assignment: 

Background

For our Swiss customer located in Basel we are currently looking for (m/f) a Regulatory Business Process Coordinator - PHARMA

  • Type of placement:  12 months, external contract with possible long term extension
  • Company:  major Pharma company in Basel area
  • Salary:  level 3, please ask us for the exact rate range 

(monthly gross salary levels in CHF,  level1= 5-10k , level2=10-15k,  level3= >15k) -PHARMA

 

Objectives and Scope of Position:

  • Coordinates business projects within PDMA department
  • Proactively collaborates with Global Product Development Medical Affairs Functions throughout the business project
  • Collects and analyses project management data and information
  • Communicates across functions and departments regarding PDMA projects

 

Summary of Main Responsibilities:

Communication

  • Cross-functional process review meetings
  • Manages Global business process email account
  • Organises and leads Team meetings with PDMA representatives
  • Acts as one of the main contact persons for inter-departmental communication and communication with external business partners
  • Provides feedback to Pharma Affiliates

Documentation and data management

  • Collects, reviews and distributes business process documentation and data according to the timelines
  • Ensures accurate tracking of key process tools, documents (CSRs, protocols etc.) and data
  • Runs, updates trial list outputs and ensures the quality is according to the required standards
  • Ensures business process systems (CTMS, AIMS) kept up to date and manages system support requests
  • Archives Clinical files and documents in the appropriate filing area

Business Process Overview

  • Planning business process implementation phases and execution according to the timelines
  • Builds relationship with key internal and external business process stakeholders to ensure PDMA needs and goals are met
  • Coordinates regular business project activities( trial lists updates, keeps process trackers up to date, monitors and analyses data deliverables)
  • Ensures adherance of high level deliverables according to the timelines
  • Guides, coaches and supports junior team members if needed

Compliance

  • Is responsible for acting in line with legal, regulatory and company standards and codes of practice (eg Roche Code of Conduct, applicable directives, guidelines and SOPs)
  • Completes all required training modules as a priority

 

Generla information

  • reason:back fill for a contractor who resigned
  • must haves for that role: see attached "profile" - typically draw people from stats programming, clinical operations or data management backgrounds
  • /Option to extend: Yes
  •  Home office: No fixed arrangement - but flexible and could accommodate as needed
Requirements: 

Profile - Business Process Coordinator

  • An engaged, smart person, that gets things done: Ability and track recordof being hardworking, self-motivating and achieving results is a must.Proactive and keen to take initiatives. Pragmaticand hands-on. Energetic and quick.
  • A teamworker and collaborator: Open, supportive of others, flexible, collaborative outlook. Ability to build trust quickly.Ability to manage and influence many, diverse stakeholders, in a cross-functional environment. Outwards looking, and integrative.
  • Rational, clear, structured and detail-oriented: Ability to quickly and clearly establish structure around problems / systems / processes / argumentation. Ability to handle both detail and big picture. Structured, thorough, accurate, consistent.
  • Strong communication skills:Written, verbal and presentational, in a diverse multicultural environment. Ability to confidently represent the group. A good, empathic listener – able to understand and communicate with people having diverse perspectives.
  • Maturity and ability to handle ambiguity: Calm and measured when under pressure. Ability to interpret and act appropriately on incomplete or conflicting information. Ability to cut through complexity and simplify.
  • A good complement/balance for current members of the team:Do they bring perspectives and or skills that we don’t have in the team at the moment? Will they challenge and stretch us in a good way?Will we enjoy working with them

 

Qualifications:

Successful candidates will demonstrate: 

  • A collaborative, supportive and engaging approach with people.
  • A forwards-looking, agile, energetic and action-oriented approach to work.
  • Attention to detail and quality.
  • Strong communication and organizational skills.

You will bring 5 or more years of experience in Clinical Science, Pharmacovigilance, Biometrics, Regulatory or Operations functions within the Pharma industry, with knowledge of: 

  • Clinical trial documentation such as Protocols and Clinical Study Reports.
  • Clinical trial management systems and trial-level data.
  • Clinical trial databases and patient-level data.

Expected Qualifications: 

  • A Bachelors / Masters level Scientific degree.
  • Minimum 5 years of experience, working within the Healthcare / Pharma environment.
Prefered Interview Dates (YYYY-MM-DD): 
2018-07-20