Job title: Senior Manager – Medical Affairs – Mumbai
Company: Boehringer Ingelheim
Job description: OUR COMPANY
At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective.
Now, we are powered by 52,000 employees globally who nurture a diverse, collaborative and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve.
To provide clinical and scientific leadership, working with stakeholders at local and national level to ensure that the commercial objectives are realized whilst protecting the interests of the client, patients and Boehringer India
Tasks & responsibilities
- Provide tactical and strategic inputs to Head Medical Affairs Specialty for developing scientific partnerships with external experts and key medical organizations.
- Provide tactical and strategic inputs, and business/technical expertise, to Product Management towards ethical promotion of assigned products, in the operational areas listed
- Identify and establish relationships with external experts/organizations in select therapeutic area within the region to support their clinical and research activities by understanding their needs and offering appropriate research projects, medical programs, clinical/educational grants, logistical support, and funding where feasible.
- Coordinate medical grant requests for relevant therapeutic area including merit assessments, alignment with Boehringer-Ingelheim’s research objectives, quality of documentation and potential for relevant outcomes
- Provide strategic inputs and support towards creation of marketing/brand plans/medical development plans, and towards design and execution of medical-marketing programs/clinical programs, including initiatives to enhance access to medicines
- Initiate and/or review and/or approve promotional, training, and Continuing Medical Education (CME) material in compliance with relevant SOPs/regulations/industry codes/working practices
- Participate/facilitate/conduct customized promotional/educational interactions with Health Care Professionals (HCPs). These interactions include, but are not limited to, customer launch meetings, advisory boards, CME programs, scientific symposia, institutional presentations, etc.
- Support efforts to identify new investigators and institutions for Clinical Research in order to expand research base.
- Ensure effective integration (into local buisness) implementation of regional clinical and research activities in accordance with therapeutic area strategy
- Critique the design of clinical research studies and provide recommendations for changes.
- Support site selection (feasibility studies, site recruitment, identification, capability assessment), attend and contribute to investigator meetings, and conduct and participate in advisory boards and consultant educational forums
- In consultation with concerned stakeholder/vendor/interface, develop/write and/or review and/or approve protocol synopsis/final protocols/supporting documents per need (e.g., investigators’ brochure (IB), informed consent form (ICF), patient information sheets, etc)
- Collaborate with Study Management in providing training to in-house project teams (CRAs, project secretaries/assistants) and site project teams on clinical research methodology, study design, protocol/CRFs through on-site coaching/training sessions/workshops for local studies
- Assist in planning, organizing and preparing Investigational New Drug Applications (NDAs)
- Assist in answering medical/safety queries on CTA raised by local regulators
- Participate/facilitate/conduct Investigators’ meeting and/or initiation visits prior to study start
- Provide medical support towards medical monitoring of ongoing local studies, including need-based visits to study sites
- Provide medical support to safety staff, as and when required, for safety reporting.
- Review and provide protocol waiver requests from investigators for local protocols
- Review/interpret data generated; write final reports for locally sponsored studies as required
- Develop and execute Publication Plan; review/approve/write manuscripts for publication of locally sponsored studies
- Develop and execute Information Dissemination Plan/Program
- Facilitate Marketing/Sales Force access to EEs where appropriate.Answer Medical Information Queries
- Support / Lead marketing and sales initiated projects that align with therapeutic area requirements and involve EES
- Co-ordinate educational/scientific programs arranged by the Sales Force.
- Provide scientific and medical support to institutional sales initiatives.
- Participate in and provide medical inputs for key opinion leader meetings / advisory boards, Customer Launch Meeting (CLMs).
- Provide medical training to new sales staff on basic sciences/ TAs/assigned products. Provide refresher training to sales staff through ongoing training initiatives
- Provide pre-launch and launch training to sales staff for new products
- Provide medical and product expertise towards registration of new products/indications with federal/state regulatory authorities through delivery of scientific presentations, provision of medical rationale and published literature, and liaison with key HCPs for obtaining support for new product/indication.
- Education : MD and MBBS no specific specialty
- 5 years experience on MBBS
- 3 years as a medical advisor
- Knowledge of “pharmaceutical medicine” including clinical pharmacology, medical and paramedical sciences, medicine and medical statistics, and relevant Therapeutic Area/Products
- Knowledge in clinical trial design and methodology, and understanding of interfaces, and conduct
- Basic knowledge of pharmaceutical industry, drug discovery, research & development, commercialization, promotion, and applicable policies, procedures, regulations, and guidelines
- Communication skills, both written and verbal (including medical writing and presentation skills)
- Analytical skills and reasoning, and sound medical judgment/decision making
- Interpersonal skills, internal & external networking and the ability to impact and influence
- Will be base on Mumbai
WHY BOEHRINGER INGELHEIM?
With us, you can grow, collaborate, innovate and improve lives.
We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth. We also offer a competitive salary, generous amount of vacation time, numerous benefits towards your wellness & financial health and work-life balance. Plus, an onsite gym, best-in-class cafeterias and coffee bars to keep you energized and healthy and other various benefits and rewards. Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities.
READY TO CONTACT US?
If you have questions about the application process, please contact HR Direct: , Tel:
Location: Mumbai, Maharashtra
Job date: Wed, 02 Mar 2022 01:38:16 GMT
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