Medical Governance Manager

2 weeks ago


Mumbai India AstraZeneca Full time

Job Description Job Title: Medical Governance Manager About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization 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. Business Description AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas Oncology; Cardiovascular, Renal & Metabolism; and Respiratory & Immunology. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. At AstraZeneca, we share and are motivated by the same purpose: pushing the boundaries of science in order to deliver life-changing medicines to patients around the world. In short, our work has true meaning. Everything we do is underpinned by our dedication to being a Great Place to Work. We recognise that our people are our greatest asset and know what's possible with a talented and diverse team that believes in what science can do. Business Area Overview An industry-leading Medical Affairs team, generating and communicating compelling medical evidence that changes the practice of medicine for the benefit of patients and shapes the future of AstraZeneca Job Overview - The role of Medical Governance Manager (Nominated Signatory / MGM) covers a set of responsibilities for final approval of specified promotional materials or non-promotional materials, meetings and activities (such as market research, external funding requests and patient support programs), interactions with Health Care Professionals (HCP) and Health Care Organisations (HCO) and other related areas such as non-promotional health education materials for the India Marketing Company (AZPIL). - This is an important responsibility undertaken on behalf of the Company. It adds value to the Company and reflects the importance of doing business in a compliant and ethical manner and the AstraZeneca values of Doing the right thing and We are entrepreneurial. - The MGM work in a matrix structure - reporting into the Medical Excellence Lead within Medical Affairs yet having alignment with Therapy Areas. MGM is part of brand cross functional teams across all Therapy Areas. - Individuals allocated to this job perform Nominated Signatory duties. - MGM role requires qualifications in medical/health or science, up to date training and experience applying relevant industry codes of practice, and previous pharmaceutical industry experience, ideally in such roles from Medical Affairs which have required assessment of materials and activities relating to compliance. Job Description Below responsibilities reflect a broad spectrum that may be included in the role depending on the life cycle of the portfolio and the therapeutic area focus, as such this may change over time. - Ensure compliance with codes of conduct/practice, internal standards and local legislation relating to promotional and non-promotional activities and interactions with HCPs and HCOs. - Provide consultancy and ensure delivery of medical and scientific support to internal and external customers across all therapeutic areas. - Provide leadership and enhance medical compliance capabilities across AZPIL and drive a company-wide culture of compliance. - Seek opportunities to simplify and improve our approach to medical compliance which aligns with the AZPIL business objectives Compliance - Be comfortable working in a compliance framework which is principles based where there are levels of ambiguity and not always a right and wrong answer. Using pharmaceutical industry experience and pragmatism to assess situations and make judgements relating to compliance - Conduct thorough and efficient review and approve promotional and educational material/activities in accordance with UCPMP legislation, Codes of Conduct/Practice and AstraZeneca internal standards, ensuring consistency with product license. - Act as the subject expert for compliance questions from other functions within AZPIL such as sales/marketing/medical teams - Proactive, early-stage guidance of brand cross-functional teams across all therapeutic areas, in the development of promotional and educational materials, activities, and external funding requests (sponsorships, donations and community investments) by advising on alignment with compliance frameworks and offering compliant solutions to enable innovation. - Have strong therapy area and product knowledge and be able to conduct critical evaluations of evidence to ensure use of evidence in materials and activities is appropriate - Ensure brand claims are scientifically balanced, fair and accurate with respect to all available evidence, reflecting good medical practice, ethical issues and tone, combined with intelligent risk management and solution identification. - Assist brand teams to defend strategic brand claims against complaints by competitor companies and challenging unacceptable practices of competitor companies. - Act as a point of contact and provide guidance on Fair Market Value (FMV) rates and local compliance policies for international marketing colleagues whenever an Indian HCP is engaged. - Provide input into development and update of local SOPs to maintain currency with external and internal codes and guidelines - Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. - Report potential issues of non-compliance to AZ Ethics or other as appropriate - As part of the Medical Compliance Team and to drive consistency in approach across AZPIL, attend and contribute to team by offering expertise and ideas. - Foster a culture of openness in which employees are comfortable raising questions or concerns and communicate willingly and openly. Facilitate the reporting of instances of non-compliance. Learning and Capability Development - Develop and deliver education and training to other teams within AstraZeneca (such as but not limited to commercial and medical teams) in the provisions of the UCPMP Code of Practice, while supporting Corporate Governance in education of the Global Policies related to the nominated signatory role. - Develop and deliver education and training to the Medical Compliance Teams on subjects identified as an educational need. - The MGM will have a feedback culture with the intent of continual improvement, so request and provide feedback freely, and participate in quality monitoring activities within the team. - Drive consistency of interpretation of the AstraZeneca Policies, Standards, Guidelines and SOPs across the business - Lead continuous process simplification and efficiency improvements. Support and contribute to broader business objectives through a cross functional and enterprise mindset. Policy/Code Knowledge - Demonstrates and articulates understanding and application of the legislation related to promotional and educational material and activities; - Recognises implications to AstraZeneca of any breaches of these standards and be able to effectively communicate these when providing advice to the business; - Demonstrates and articulates understanding and application of AstraZeneca local governance procedures and reporting requirements; - Critically evaluates and monitors therapeutic area specific competitors and stakeholders promotional and educational materials and activities for compliance with relevant legislation and takes action when these materials and activities are not in compliance or impact on adversely on AstraZeneca business; - Evaluates medical/clinical strategies proposed for AstraZeneca products within designated therapeutic areas and takes action to adjust them to ensure both scientific and commercial objectives for products are met, at all stages of product lifecycle. Communication And Leadership And Other - Excellent written and verbal communication skills and the ability to clearly assert the position of compliance by providing the why behind every consideration. - Strong attention to detail - Comfortable working in an environment of fluctuating workloads - Ability to prioritise work received from different teams. - Mentoring and/or onboarding/induction of new Medical Governance Manager - Successfully take on additional projects outside immediate TA(s) yet related to MGM function, local or regional. Core Accountabilities - Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance. - Adherence to internal processes and external regulations including but not limited to clinical trials, promotional activity to meet internal SOP and local regulations. Education, Qualifications, Skills And Experience - Science/Medical qualification - Pharmaceutical Industry experience in a medical compliance role - Knowledge of relevant local legislation - Demonstrated ability to set and manage priorities, resources goals and project initiatives - Prior experience in governance/review of materials and/or events - Cross functional teamwork approach - Problem Solving skills - Advanced conflict avoidance and resolution skills - Critical appraisal/analytical skills - Excellent oral and written communication skills - Excellent presentation skills - High attention to detail - Medical Marketing experience 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. You can find alternative messaging to use in the Global Talent Attraction Story messaging section of the Global Playbook on the Employer Brand Portal - try to use other examples in order to make it different for candidates So, what's next - Are you already imagining yourself joining our team Good, because we can't wait to hear from you. - Are you ready to bring new ideas and fresh thinking to the table Brilliant We have one seat available and we hope it's yours. - If you're curious to know more then please reach out to (contact person) We welcome with your application, no later than (Month) (XX) Where can I find out more Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/ Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/ Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/hl=en If you have site, country or departmental social media then feel free to switch any of the above links. Date Posted 26-Nov-2025 Closing Date 09-Dec-2025 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.



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