(Associate) Medical Affairs Manager, ONCO - HCM

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Job Description / Capsule
An internal and externally facing medical role that provides medical and clinical expertise in priority therapeutic/disease areas and builds AZ scientific leadership. Participates and contributes with medical and clinical expertise in design of LCM and Brand Strategy. Takes leadership in implementation of Medical Plan/ activities in alignment with Brand strategy. Ensures that the Medical Activities meet the needs of patients and customers. Engages Opinion Leaders in ESRs, scientific exchange meetings and advisory board meetings. Defines and delivers training on Medical background of the product or various functions in an organization. May take responsibility as Nominated Signatory medical reviewer for activities and promotional materials. May take responsibility for mentorship of MSL/s in the country. May lead Medical Information and
Pharmacovigilance within a particular market.
Objectives
1/
To establish AstraZeneca as a scientific leader through proactive, updated and effective Medical input
Critical actions
Continuously acquire and update necessary scientific knowledge on therapeutic area and relevant compounds.
Develop and implement the local medical plan to address unmet medical needs in priority disease areas and ensure alignment with the brand plan.
Collaborate with MSL to seek input from MSL insights for development of local medical plan .
Develop and implement pre-launch medical plan/activities for new products at least 2 years prior to the planned launch in the country to address key clinical and scientific challenges
Provide medical leadership on faculty and content development for medical programmes including national congresses, advisory boards, scientific exchange meetings, publications, CMEs to meet identified needs
To ensure that the Medical Information provided both to external and internal customers is timely, relevant, accurate and scientifically balanced
Provide local medical expertise to local area/regional brand teams
Provide medical input to phase 1 to 4 study protocols, study feasibility and support operational delivery
Provide Medical expertise to support PSP market research, PASS and ESRO
Measures
(Quantitative – Qualitative – Attitudinal)
Quantity
Completion of the medical academy
Number of reactive ESRO discussion
Delivery of approved prelaunch medical plan in cooperate with local brand strategy
Implementation of the prelaunch medical plan.
Quality
Proactive update of medical knowledge in the internal meeting
An approved Medical plan that is fully aligned with the Brand plan.
Medical information should meet defined markets standards – time, quality in 5 days.
2/
To engage scientific leaders, professional bodies or societies to establish AZ as a scientific leader
Critical actions
40% of time in field is required for engagement with the highest priority HCPs and key external stakeholders engagement
Share emerging data with HCPs, discussing all aspects of the data in a scientific, objective and balanced way
Disseminate results of studies completed to medical community by translating their clinical values and incorporating into business strategies
Attend relevant scientific congresses and HCP meetings to gather new knowledge on AZ compounds, competitor information and therapeutic area
Conduct professional scientific communication or presentation (become chairperson/presenter when necessary) with key opinion leaders (prominent
Liaise with local investigators and the External Sponsored Research organization to support research initiatives.
Internally communicate competitive intelligence
Measures
(Quantitative – Qualitative – Attitudinal)
Quantity
Time in field versus plan
Timeliness and actual number of achievements: P2P, 1:1 interaction, advisory board, publication, CME, responses to queries versus plan
Market preparation of new launch product and/or pipeline among OLs.
Quality
Customer feedback post events/symposia
3/
Generate the medical evidence to support the brand strategies in priority TAs to meet unmet medical needs
Critical actions
Idea generation of the company sponsored clinical research
Oversight and accountability of the operation of the studies
Initiate research discussions, for example NIS, with customers to develop studies that will fulfil global and local business strategies. (May as part of the review team conduct initial assessment of any ISS proposals)Participate as key member of brand team as strategic partner towards LCM actions including potential business development opportunities
Develop NIS or registry studies to address unmet medical needs.
Developing partnership with OLs in order to develop their capabilities of conducting medical studies
Measures
(Quantitative – Qualitative – Attitudinal)
Number of discussion - NIS/IIS Proposals
Oversight the all accountability of the operation of the studies, i.e. Milestones, quality and capacity of the study
Timely publications of studies completed
Initiatives with investigators to develop capabilities in conducting medical studies
4/
Provide medical expertise to shape regulatory environment to achieve rapid and high quality market access of AZ products including new registration, new product evaluation and life cycle
Critical actions
Support to develop drug value pack and communicate it to Key Decision Makers
Support market access activities that shape market understanding of disease, diagnosis and treatment options
Proactive crossfuctional collaboration with regulatory and other teams in drug registration in earlier and broader accessibility aligned to the brand strategy
Measures
(Quantitative – Qualitative – Attitudinal)
Quantity
Number of communications to KDMs versus plan
Meet the critical project timeline
Quality
Feedback from crossfunctional team
5/ Defines and delivers training on Medical background of the product for various functions in an organization as required
Critical actions
Provide effective Medical/clinical trainings (basic science and disease knowledge, drug profile, clinical data) to internal colleagues in line with expressed needs of MSL manager and sales managers:
Ensures own knowledge and knowledge of team members of best practices and new relevant developments is up to date
Measures
(Quantitative – Qualitative – Attitudinal)
Quantity
Percent completion of trainings conducted versus plan as per the business needs versus plan
Quality
Feedback from participants ; facilitator effectiveness average more than 4 points
MSL and MR competency in terms of disease knowledge, drug profile and clinical data (through MSL Accreditation)
6
/
Governance and ensuring overall adherence to processes and regulation [include but not limit to patient safety, clinical trials, promotional activities, etc …]
Critical actions
Accountable for ensuring Promotional Compliance: Provide medical input to the creation, development and agreement of promotional material and ensure all material is in line with internal SOPs and meets IFPMA code
If appropriate to market, Ensure that Pharmacovigilance activities meet internal SOP and local regulations
Ensure clinical studies are carried out in accordance with AZ SOPs and cGCP. Support Clinical team to select appropriate investigators and sites optimising quality, delivery and commercial benefit
Aligns with the values and vision of AZ
Actively participate/encourage the development of the AZ culture
Ensures compliance with AZ code of conduct, Corporate Governance, Audits requirement, guidelines, codes, policies and procedures
Ensures that company confidentiality is maintained (i.e. intellectual property, product, strategic and salary information)
Discloses potential breach of codes or conducts
Measures
(Quantitative – Qualitative – Attitudinal)
Display behaviours consistent with the AZ vision and values (those with line report, their team members demonstrates the same)
Feedback from others; climate survey
No non-compliance issues raised with local and global policies and procedures
No valid complaints