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Lead Scientific Affairs

Lead Scientific Affairs

KapivaIndia
4 days ago
Job description

Essential Qualification : MD (Ayurveda) / BAMS  Experience : 8-10 years experience in managing scientific affairs / medical affairs in ayurvedic / wellness company. Having authored publications will be an advantage.  Preferred Age Group : 30-40 Job Summary : Lead, Scientific Affairs. The ideal candidate will be responsible for leading and overseeing the scientific communication of scientific content across multiple therapeutic areas for both regulatory submissions and consumer communication. The Lead will drive the strategic direction of scientific affairs, ensuring alignment with organizational goals and regulatory requirements, and will act as a liaison between cross-functional teams to support product compliance and marketing communication compliance. He will also lead the claim substantiation of all the claims of the products across all touch points by providing support in terms of anecdotal evidences / preclinical / clinical studies as deemed necessary . Key Responsibilities : Scientific Strategy Development : Provide scientific insights and expertise to support clinical and regulatory activities, product development, and commercialization efforts and ensure that scientific communication is consistent, accurate, and aligned with internal and external stakeholders. Conduct clinical trials through CRO’s / universities / agencies, manage the trial protocol / budget and meet the deliverables of the clinical trials Cross-functional Collaboration : Collaborate with R&D, clinical development, regulatory affairs, and commercial teams to ensure scientific rigor in all stages of product lifecycle. Provide scientific guidance to marketing and sales teams to ensure accurate messaging and support of product claims. Represent the organization at scientific meetings, conferences, and advisory boards. Work with the Physicians of Kapiva and publish the PMS reports as case studies Scientific Communication and Education : Lead the creation of scientific content for external communication, such as publications, posters, abstracts, and presentations. Ensure publication of claim substantiation reports / reviews / clinical trial reports. Oversee the preparation of scientific materials for internal training, ensuring teams are well-equipped with the latest scientific insights. Regulatory and Compliance : Support regulatory submissions with scientific content and evidence-based recommendations. Ensure compliance with industry standards, regulations, and guidelines in all scientific activities. Market Intelligence and Competitive Analysis : Monitor scientific literature, clinical trial data, and competitive landscape to identify emerging trends and therapeutic opportunities. Provide actionable insights and recommendations to senior leadership based on market intelligence. Training and customer support Train the internal stakeholders time to time on the claims and the trial reports, also train the doctors on the product and product communications. Support the the customer support / R&D and doctors team as and when required on ADR’s or customer complaints on efficacy and safety Additional responsibilities  Continuous improvement of the existing products  Co-ordination with CRO / Ayurvedic hospitals / colleges / universities  Close co-ordination with internal and external stake holders  Regulatory compliances of all communications across all touch points  Ability to work collaboratively in a fast-paced, cross-functional environment.  Detail-oriented with a commitment to delivering high-quality results.  Scientific publications / popular articles Expected knowledge / hands on experience  Strong knowledge of Ayurvedic practices  Good command on scientific publications both in terms of publishing our work and deciphering and using available related published work  Post market surveillance  ADR’s reporting and solutioning