Medical Affairs Manager

Job title: Medical Affairs Manager

Company: AstraZeneca

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 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

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.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn

Follow AstraZeneca on Facebook Follow AstraZeneca on Instagram

Date Posted 07-Nov-2022

Closing Date 31-Jan-2023

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.

Expected salary:

Location: Bangalore, Karnataka

Job date: Tue, 08 Nov 2022 02:39:15 GMT

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