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Communication - Medical Affairs Manager - Belgium
Keyrus Biopharma (company)
Posted on : 10 July 2017
As Medical Affairs Promotional materials Project Coordinator within the company, you will join the Independent Medical Reviewers team in the Medical Affairs department on client’s site and will be accountable for managing and overseeing the electronic tool for review and approve promotional material and non- promotional materials according to the copy approval process in corporate policies and SOPs.
Role and main tasks:
Tool Management and administration
- First line daily User support: core administrative functionalities (including copyrights and system update)
- Tool Management oversight: access requests, disabling profiles, login user profiles, cleaning of job bags, archiving/withdrawal/re-approval
- Communication to teams: ways of working (wow), tips, deputation
- Documentation area update: training slide deck, review licenses
- Related Training requirements: define/update training requirements (newcomers/refresher)
- Related modules (Fundamentals, Reviewer, Originator)
- Update the training curriculum with the updated SOP and new business wow
- Update with changes in copy approval processes and SOPs
- End-Users training (Agencies, Operators)
- Manage and keep update team site in line with copy approval process and corporate policies and SOPs
Knowledge Center management
- Close oversight of the outsourced Knowledge Center team: training, monitoring, resourcing, updates in methodology
- Quality check: back-end monitoring of promotional materials (quarterly basis)
- Copy approval process operators: supervision of operators and administrators at knowledge center level on regular basis (livemeetings, daily guidance)
- Coordinate the delivery of First Level (L1) monitoring (internal control framework) programs according to copy approval process and corporates policies and SOPs and ensure partnership with medical affairs senior management and quality for research and development (Quality for R&D) to design and implement sustainable improvement in L1 criteria
- Building correct reference pack within the tool
- Budget oversight
- CPCD reports (monthly)
- Time to approve promotional materials (quarterly)
- Workflow reports (monthly)
- Re-approval materials (quarterly)
- L1 reports (quarterly)
- Understanding of the ethical, regulatory, compliance and legal framework related to the delivery of promotional materials to be used internally and externally
- Knowledgeable regarding Industry Codes and promotional material processes
- Strong interpersonal and influencing skills
- Computer wise
- English skills; French is a plus.
- Positive attitude
- Costumer orientated
What we offer
- You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…).
- Each employee will be welcomed with a varied integration program.
- We invest considerable time and resources in training our staff (technical and non-technical courses).
- You will join a dynamic and international environment with enthusiastic and professional colleagues.
Who We are
- Our company is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence.
- Our ‘human’ approach to service provision is what differentiates us from our competitors.
- Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
- We’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
- From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Bio statistics, Medical Writing & Medical Information, Real World evidence services.