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:
- 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
- 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
- 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
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
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.
- A Bachelors / Masters level Scientific degree.
- Minimum 5 years of experience, working within the Healthcare / Pharma environment.