Job title: Sr. Global Medical Development Manager

Company: The Medicines Company

Job description: Job Description 1886! We have more than 130 years of experience treating patients. Sandoz, a division of Novartis, is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide. T

Job Description 1886! We have more than 130 years of experience treating patients. Sandoz, a division of Novartis, is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide. The Senior Global Medical Development Manager (SGMDM) provides medical development expertise and medical supervision to the development of products (including complex ones). This includes responsibility for the medical aspects of setting up/ executing the development strategy (e.g. medical impact of technical aspects), medical contribution to the overall clinical strategy and individual clinical studies in close collaboration with the clinical development team. The SGMDM provides knowledge on disease state, patients’ needs, comprehensive understanding of the medical development relevant scientific literature and treatment and development guidelines. They serve as a medical / scientific knowledge reservoir with respect to Sandoz products in development / life cycle management development activities. The SGMDM works with a high ethical standard in compliance with GCP and all relevant internal and external guidance documents. YOUR KEY RESPONSIBILITIES: 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. . Represents company for development projects as medical development expert to Health Authorities (e.g. during Scientific Advice), expert specialist advisors and key opinion leaders builds up, develops and manages relationships with these stakeholders. The SMDM is responsible to develop the medical content for such interactions (e.g. briefing book). . 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 (e.g. research collaborations, KEEs). . Provides input to clinical study design (including study population) and owns the preparation of scientific documents (e.g. Investigator’s Brochure and patient consent form for non-standard generics clinical development [e.g. clinical endpoint studies or BE studies in patients]), contributes to annual safety reports, Risk Management Plans. Participates in the Sandoz Study Board for applicable projects. Aligns with Clinical Development for reporting of clinical data in Clinical Overview. . For complex projects: Provides medical development expertise and medical supervision to the development of overall strategy and objectives of the Clinical Development Plan and to the design, conduct and reporting of clinical trials . 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 including facilitating adoption of digital measures / platforms across sites, and to external partners. Acts as lead within Medical Office for such initiatives. . Performs Medical Monitoring for clinical studies in patients according to applicable requirements. . Medical interpretation of study results for clinical endpoint or safety studies. . 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 Medical Development in the responsibility for drafting of contracts, cost optimization and management, professional and regulatory complianceMedical writing for registration purpose: Medical and clinical documentation 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) . 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). Participates in the Sandoz Study Board as necessary. . Ability to step in a coaching role for more junior colleagues. . Ability to cover all Therapeutic Areas. . Lead/Drive 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. [#video#https://www.youtube-nocookie.com/embed/ggbnzRY9z8w {#400,300#}#/video#] 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. . 5+ 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. Why consider Sandoz? Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world? The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks. Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics. Imagine what you could do at Sandoz! Commitment to Diversity & Inclusion: Sandoz, a Novartis company, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Expected salary:

Location: Hyderabad, Telangana

Job date: Sun, 26 Dec 2021 23:21:37 GMT

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