Aspen Pharma Group
Job title:
Head of Medical Affairs – EME – London
Firm
Aspen Pharma Group
Job description
Position ObjectiveTo handle the medical affairs division, in alignment with the organizational technique and goals as per Aspen code of compliance and trade requirements.
To handle and oversee medical info, Promotional non promotional compliance and medical scientific help for the Aspen EME present portfolio and enter required for constructing a stable pipeline.
Journey required wherever mandatory.Obligations
- Supervises high quality, compliance and efficiency metrics associated to medical info, medical compliance and Medical scientific engagement processes and communicates with key stake holders, the place mandatory.
- Create procedures to make sure compliance with international, EME regional and native laws, guarantee constant requirements and well timed responses.
- Ensuring that compliance on inner procedures, insurance policies, codes, methods, and controls are up-to-date and efficient.
- Help High quality Administration by contributing to the coverage developments and roll out related to medical info, medical compliance, and medical scientific engagement.
- Oversee Medical affairs resourcing and forecasting to make sure that medical affairs operate can meet KPI’s in compliance with regulatory necessities, inner insurance policies, and processes.
- Guarantee help and coaching is delivered to native workforce and distant workforce, the place mandatory.
- Present departmental enter on change controls raised by Aspen.
- Help medical info workforce in implementation, validation, and upkeep of medical info database globally or related methods used to help medical info actions.
- Guaranteeing associates and repair suppliers are educated in enquiry dealing with and compliance is monitored on an ongoing foundation.
- Carry out high quality management actions throughout associates and repair suppliers to make sure that medical info service is delivered in step with agreed course of, insurance policies, or contracts.
- Oversee Medical vendor (s) efficiency and audit exterior Medical Service supplier in figuring out any deficiencies in total service supply.
- Create, educate, and develop consciousness on Aspen insurance policies and Code of Advertising and marketing Follow
- Present scientific and scientific enter into the event of non-promotional and promotional supplies.
- Approval and evaluation of academic and promotional supplies by Veeva Promomats or different recognized platform as per Aspen insurance policies and procedures, the place requested.
- Guarantee Aspen EME adhere to all regulatory requirements and firm insurance policies related to all promotional materials.
- Develop and keep working relationships with advertising and marketing and business colleagues and with key stakeholders in Aspen Pharma to reinforce cross-functional teamwork and success.
- Develop experience and scientific analysis of assigned therapeutic areas to all native affiliate medical approvers.
- Help line supervisor in growing and sustaining the method for managing compliance monitoring course of.
- Help in sustaining threat register throughout all affiliate territories and report any vital threat to senior administration.
- Co-developing and implementing buyer going through interactions and have a main liaison position to the medical and scientific neighborhood, accountable for partaking Clients, together with HCPs, in non-promotional medical and scientific discussions relating to on-market and in-development, pipeline Aspen merchandise, or on matters regarding illness states.
- Take part within the choice course of to establish appropriately certified specialists the Firm would want to have interaction in collaborative efforts – equivalent to potential analysis collaborations, or academic and advisory roles (Advisory Boards, Congresses, Symposia, and so forth.); whereas making certain a excessive stage of scientific or academic integrity in these collaborative efforts
- Help inner groups equivalent to gross sales and advertising and marketing and members inside the regional group to develop scientific experience by the supply of scientific replace shows.
- Guarantee a robust medical and scientific presence for Aspen portfolio in key markets by facilitation of academic initiatives, whereas supporting requests for medical and scientific info on merchandise or areas of therapeutic curiosity to Aspen EME.
- Consider present, future potential therapeutic areas, scientific developments, and pipeline merchandise to guage hole lists and supply potential pipeline portfolio.
- Assess and help Advertising and marketing and Enterprise Improvement Crew to guage all scientific, scientific knowledge offered for pipeline BD potential merchandise and evaluating knowledge and interesting with HCP’s to know the necessity, scientific medical want and accordingly translate this to info supporting the choice making course of
- Act as a medical signatory within the approval course of for promotional & non-promotional actions for the UK & Eire;
- Present scientific enter to leverage the accessible knowledge to optimise the event of promotional & non-promotional actions in UK;
- Guarantee compliance with related Codes of Follow and keep away from breaches of stated Codes in UK e.g. PMCPA Code of Follow, Proprietary Affiliation of Nice Britain Code, Medicines Act, MHRA tips and Aspen SOPs. Preserve consciousness of adjustments to all related Codes to make sure recommendation is up to date accordingly.
- Certify UK supplies in Veeva Promomats to make sure compliance from a medical perspective.
- Help the UK Advertising and marketing workforce within the improvement of promotional / academic campaigns.
- Help the event of native inner SOPs regarding compliance with the related Codes of Follow.
- PHD Physician of Pharmacy/ Physician of Drugs, medical practitioner or a pharmacist registered within the UK
- Minimal 5 years of expertise in In Medical Affairs
- Minimal of 8 years of expertise in medical/pharmaceutical trade position
- Means to know and interpret scientific knowledge,
- Expertise in Facilitator coaching.
- Good understanding about regulatory and authorized atmosphere
- Good data in audit course of
- Expertise in working with voluntary codes equivalent to EFPIA, ABPI, IPHA and so forth.
- Expertise in Drugs Affairs and compliance monitoring can be an added benefit.
- Laptop literate – MS Workplace, Excel and Energy level, Veeva Promomats or equal
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Anticipated wage
Location
London
Job date
Solar, 07 Apr 2024 03:03:49 GMT
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