Medical Reviewer Business Partner - Remote
Posted on :
26-06-2024
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Job Description
Overview:
TekWissen Group is a workforce management provider throughout the UK Europe and many other countries in the world. The below client is an American multinational pharmaceutical and biotechnology corporation.
Job Title: Medical Reviewer & Business Partner
Location: Remote
Job Type: 6 Months
Job Description
- To provide specialist Code advice and review/examination services to the nominated internal team(s) to support the appropriate use of clients medicines and successful implementation of ciients promotional and nonpromotional materials initiatives and programmes. These internal teams may comprise sales and marketing colleagues and those in nonpromotional roles (eg patient experience/engagement roles healthcare development) as well as colleagues outside the BU working on BU related activities such as corporate affairs colleagues.
- To provide endtoend medical partnership to the nominated internal team(s) from strategic conception of the programme through to content development and approval.
- To maintain the highest standards for clients material in line with the ABPI Code of Practice other applicable laws and regulations and clients policies.
ROLE RESPONSIBILITIES
- Provision of Code Expertise as a Medical Reviewer
- To review promotional and nonpromotional materials and activities in line with the requirements of the ABPI Code of Practice.
- To review and signoff materials as the Appropriately Qualified Professional (AQP) if named as a clients AQP
- Provision of Scientific Expertise in Relation to Content of Materials
- To acquire and maintain indepth scientific knowledge of clients medicines within nominated therapy area(s) (including those in development) as well as the competitive landscape.
- Collaboration with clients teams to Enable Streamlined Content Creation
- To work with the nominated cross functional team(s) incountry and abovecountry to develop impactful and compliant promotional and nonpromotional materials of value to healthcare professionals and patients. This includes for example:
- advising on marketing programmes other promotional activities and medical education
- providing support for revisions to prescribing information and implementation of risk management plans
- working with digital materials and digital technologies
- collaborating with Medical Affairs colleagues to understand therapy area and share pertinent issues with the relevant teams
- To provide specialist scientific and Code advice to teams during the development phase of materials/projects/activities to support streamlined creation of compliant content/activities that enable appropriate use of clients medicines (where applicable) and successful implementation of materials initiatives and programmes for example:
- advising on and reviewing materials for submission to health authorities eg prevetting submissions to the MHRA
- advising on and reviewing materials for package deals and materials for patient support (eg Homecare)
- To work in collaboration with crossfunctional team(s) on preparation and review of training materials for colleagues
- To provide clear feedback and suitable recommendations to enable the above
- Provision of support for abovecountry activities that fall within scope of the Code of Practice
- To collaborate and review where required global materials and activities for example advisory boards symposia PAG donations market research.
- To ensure relevant UK Medical Affairs teams are kept abreast of global initiatives in market
- Thought Leader for Promotional Compliance Strategy
- To work in collaboration with the Code Approval Team and compliance leads to shape and evolve the promotional compliance strategy for clients and to enable industry leading ways of working that are high quality ethical and streamlined.
- Support for Regulatory Labelling and Licence Maintenance Activities
- To support nominated crossfunctional teams in the management of label updates (SPC PIL PI)
- To support nominated crossfunctional teams in licence maintenance activities including variations and renewals
Inclusive and time efficient working:
- To work collaboratively with team members and to agreed timelines.
- To effectively manage own time and workload.
Management of Complaints:
- When required to work collaboratively on managing complaints or intercompany dialogue with internal and external stakeholders. Advise on corrective and preventative actions.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Employment Type
Full Time
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