Job title: Global Medical Development Manager
Job description: Your responsibilities include, but are not limited to:
Identifies the medical development implications of pre-clinical findings, drug formulation information, regulations and any other relevant medical information.
Engages in product or indication specific analysis of existing data sources (both internal and external) where necessary / where appropriate – to develop medical insights in optimization of the formulation, medical device and medical therapy, improved clinical outcomes, enhanced value proposition, and new insights into disease pathophysiology with the aim to increase the probability of success of the product development. Includes the regular update of pharmaceutical and medical assessments (e.g. regarding efficacy and safety of medicinal products, treatment guidelines, standard of care) to support product development optimization, and to use in discussions with regulatory authorities as necessary (e.g. Scientific Advice, briefing book, PIP, including waivers and deferrals).
Provides medical input to product development teams and patent department during product development phase according to milestone guidance. Provides training of other functions in development with regard to pharmaceutical and medical issues (indications, posology, pharmacokinetics, pharmacodynamics, efficacy and safety).
Active collaboration with cross-functional partners, including, but not restricted to: other functions within Product Development; Global QA (e.g. medical risk assessments for escalations) and Pharmacovigilance (e.g. RMP/pregnancy prevention program/plan, DHPC); Technical Operations (e.g. definition of MDD); Portfolio Stewardship. Collaborates with external experts as indicated by project/product requirements.
Represents the function Medical Development as subject matter expert in cross-functional initiatives or Center(s) of Excellence (e.g. Medical Devices) and development platforms across sites, and to external partners
Medical interpretation of study results for clinical endpoint or safety studies in consultation with a senior MedDev manager or head MedDev
When development issues arise which could have an impact on subject / patient safety, gathers relevant information to either resolve issues and/or recommend decisions to amend / terminate the study or the development project (if applicable) in collaboration with appropriate functions e.g. patient safety.
Identifies and engages with contract research organizations for selected Medical Office activities; supports Head Global Medical Development in the responsibility for drafting of contracts, cost optimization and management, professional and regulatory compliance.
Medical writing for registration purpose: Medical and clinical documentation (including alignment with Clinical Development for reporting of clinical data in Clinical Overview ) for registration dossiers for new submissions, including medical input to Registration Strategy (e.g. application type, data protection period) and responses to deficiency letters during registration phase. Medical and clinical documentation during maintenance phase (e.g. Renewals, Variations), including product Life Cycle Management activities.
Prepares Medical Development Product Pack for handover to Medical Affairs for preparation of medical launch material.
Medical supervision of publication of study results (e.g. medical journals, clinical study registries, regulatory assessment reports) in consultation with a senior MedDev manager or (group) head MedDev.
Participates in the review of submitted IIT or country level post marketing studies (e.g. post marketing clinical activities such as registry / database projects, epidemiological surveys, and post-authorization studies including referral studies) under the guidance of the Head Post Marketing Studies. Participates in the Sandoz Study Board as necessary.
Ability to cover several Therapeutic Areas.
Contributes to continuous improvement initiatives, process optimization, development of relevant templates and processes, up-to-date with industry and health authority trends, gathering external/internal knowledge in relevant fields and bring it back to the broader organization.
Other tasks, as directed by the supervisor, or based on specific appointment, or determined during the annual objectives setting process, or by relevant key performance indicators. EEO Statement Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Minimum requirements WHAT YOU LL BRING TO THE ROLE:
Academic degree in medicine, pharmacy or life-science is required to ensure the incumbent has the necessary theoretical and practical knowledge to lead the science. Excellent in English, both written and spoken.
2+ years Product Development experience in the pharmaceutical industry in local or global roles. Background in medical development, clinical development and regulatory affairs. Understanding of drug development; knowledge of the regulatory environment; experience in overseeing or conducting clinical trials; understanding of trial design and methodology and have an advanced scientific understanding and medical knowledge.
Experience in interacting with regulatory authorities.
Ability to critically review current literature, providing relevance to our products and markets.
Excellent in English medical writing. Collaborative, team oriented approach. Being an adept at developing and supporting relationships across an organization as well as with key external stakeholders and the healthcare community at large. Experience being an active contributor to cross-functional teams and/or working in matrix organizations will be essential. Drive joint value generation (pro-actively taking ownership). Strong communication and presentation skills; experience operating in international medical environments.
Has strategic mind-set, able to handle complexity. Agility to work on different TA areas, with ability to anticipate and plan for the future and to see a broader picture; high quality, critical thinking, process and performance orientated; anticipates issues and implements contingency plans to avoid missed deliverables / expectations; ability for continuous learning and able to apply knowledge, expertise, gained insights to business requirements. Planning and organizational ability; budget management.
Exercises good judgment on regulatory, legal, quality and technical related compliance issues; ensures compliance obligations are met across all areas of responsibility.
Positive and can-do approach; biased towards finding solutions and win/wins; responsiveness and flexibility. High Integrity; trustworthy; strong compliance and quality mind-set. Excellent team playing and communication skills; strong sense of ownership and accountability.,
Location: Hyderabad, Telangana – Andhra Pradesh
Job date: Tue, 04 Jan 2022 08:21:15 GMT
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