Medical Affairs Manager

ABOUT ASTRAZENECA

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

An entrepreneurial spirit that keeps us ahead of the rest – we apply creativity to every task we do, taking smart risks to turn our ideas into reality. Always at full speed, we thrive in our fast-paced and dynamic environment.

Job Description

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 Signatorymedicalreviewer 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

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.

To engage  scientific leaders, professional bodies or societies to establish AZ as a scientific leader

• 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

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

Generate the medical evidence to support the brand strategies in priority TAs to meet unmet medical needs

• 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

• 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

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

• 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

Quantity

• Number of communications to KDMs versus plan

• Meet the critical project timeline

Quality

• Feedback from crossfunctional team

Defines and delivers training on Medical background of the product for various functions in an organization as required

• 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

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)

Governance and ensuring overall adherence to processes and regulation [include but not limit to patient safety, clinical trials, promotional activities, etc …]

• 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

• 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 from competitors against marketing practice

• No breach of confidentiality. All disclosures are investigated and resolved

• No critical finding in relevant internal or regulatory authority audits

Personal  development

• Develop functional capability in the role

• Communicate, develop and role model AZ culture and AZ Values & Behaviours

• Develop individual and team accountability

• Identify areas for self-development and discuss developmental needs with line manager using the 70-20-10 principle (experiential learning, coaching/networking/relationship-based learning and class room training)

• Attend & actively participate in learning programmes, training, projects and meetings (where needed)

• 100% completion of  training as required on Medical Academy

• Feedback on congress report/highlights shared with cross-functional team as planned – completed feedback templates

• Having a personal development plan and completes identified development activities as planned

• Feedback from key stakeholders (optional)

Education, Qualifications, Skills and Experience

Essential

• A medical degree with specialization, or appropriate experience, in the required product or disease area

• Medical/Scientific knowledge in the responsible disease area

• Interest in a long-term career in the pharmaceutical industry

• Excellent presentation skills

• An ability to travel

• Fluency in English is required

Desirable

• Qualified Doctor
• MSc/PhD  in a scientific discipline
• Understanding of multiple aspects within Medical Affairs
• Knowledge of the latest technical and regulatory developments (essential for Sr MAM)
• Experience of Medical Affairs function within a pharmaceutical industry (essential for Sr MAM)
• Experience in relationship and stakeholder management (essential for senior MA)
• Project management experience
• Team management experience (essential for senior MAM)

Key Relationships to reach solutions

Internal (to AZ or team)

• Senior Management within Brand or Disease area

• Medical Affairs Function

• Regulatory affairs

• Market access

• Marketing

• R&D team

• Compliance Team

External (to AZ)

• Service Providers

• Regulatory bodies

• Payor/reimbursement agency

• Other local and regional stakeholders

• Healthcare professionals

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.