Company DescriptionWith over 75 years of experience, Bioplus Life Sciences is a pharmaceutical company based in Bengaluru. We focus on advanced Biotechnology and have programs in late-stage clinical phases for global unmet needs. Our pipeline includes pre-clinical programs and block buster Novel therapeutics, with a strong emphasis on R&Dand Clinical Development.We are delighted to invite you to explore an opportunity of learning, contributing and discovering science and medicine with us as part of our global research team. Bioplus Life Sciences and its subsidiaries Theialife Inc, USA & Akeso Biopharma, Singapore have a novel portfolio of first in class and best in class novel therapeutics in discovery stage to Phase 3 clinical stage.Theialife is currently building a global leadership team in Boston, as a prerequisite to list on NASDAQ.Our lead molecule ND 10 for early onset pediatric myopia control will be applying for EU Marketing Authorization in Q1-2025 and US FDA pre submission meeting NDA meeting also in Q1-2025. As you are probably familiar with the drug discovery journey you will appreciate that is the culmination of 18 years of effort, perseverance, and devotion to a single-minded goal of creating a global biopharmaceutical company. The myopia drug opportunity is itself over USD 20 billion and there is no other therapeutic in clinical development except Atropine which has had efficacy endpoint issues. We are adding new large manufacturing capability including a 2-million-liter microbial fermentation bio foundry and significant dosage form capacity.By 2030 we intend to be amongst the World’s top 5 Ophthalmology innovation led global companies. To support, build and develop our pipeline we are looking to add Scientists, Doctors and Engineers and Technical People to our team of likeminded dedicated science warriors who have devoted their lives to pursue excellence and contribute to finding medical solutions for significant global unmet medical needs.Main responsibilities:Works with a team of Medical regulatory writers with different levels of expertise. Develops medical expertise within Medical regulatory writing (on contents, methods, and processes). Ensures compliance with regulatory requirements from various regions (FDA, EU, MHRA, and others) for activities supported. Coordinates and supports medical activities related to the maintenance of the marketing authorizations of innovative drug programs, in different therapeutic areas. Works in close collaboration with Management, Medical Affairs team, Clinical Trial Team, Global Regulatory Affairs, Global Business Development, external stakeholders, KOLs and vendors. Publish in national and international journals. Take the lead to setup systems and process. Essential Job duties and responsibilities:Responsible to provide a medical assessment with relevant and updated clinical evidence and monitoring the execution of strategic documents such as PBRERs, ACOs, DSURs, Clinical Overviews, Benefit-Risk assessments, Expert statements for MDD, Responses to Health Authority Queries, Ad-hoc literature analyses, and labeling documents for the corresponding therapeutic area or products or any other activities which are the core activities of GMLs. Drafting the extended synopsis of studies in collaboration with RWE experts. He/she will be responsible for overseeing the execution of such plans by the respective operational units in compliance with SOP, GCP, and other regulations. Writing of Key medical/clinical parts of Common Technical Documents (CTD) or Briefing packages (BP). Reviewing and approving compassionate use of individual medical requests for use of Bioplus (and subsidiaries) medicinal products for serious or life-threatening diseases for treatment outside of clinical trials. Secure delivery of high-quality medical documents on time and in compliance with internal and external standards. Collaborates effectively with stakeholders: global medical leads/medical product leads, global regulatory affairs, medical regulatory writing teams, pharmacovigilance teams, managed access program teams, external stakeholders, KOLs & vendors.Involved in continuous education of the field force.Clinical trialsPMSRWEStatistical analysisProtocol writingBudgeting8. Custodian of new treatment guidelines and update in the field of medicine.9. KOL management and engagement.Preparing and presenting Virtual and physical CMEs / RTC / ConferencesAdvisory board meetingsSpeaker managementPreparing slide deck for speakerEvidence based medicine10. New Product Development11. Market Development/Assessment12. Field force trainingVirtual and physical trainingPreparation of training slide kitsQuestion and answersTestsMonographsPeople: Maintain effective relationships with the end stakeholders (Medical, regulatory, pharmacovigilance community) within the allocated Global business unit and product – with an end objective to develop medical regulatory content as per requirement, Interact effectively with stakeholders in medical and pharmacovigilance departments Constantly assist the medical regulatory writing team in developing knowledge and sharing expertisePerformance:Secure deliverables (PBRER, ACO, SO, CSR, ID Cards, Investigator brochure, clinical evaluation report, briefing packages, medical section of CTA, CTD, SBRAs, MDD, HAQs or any other activities which are core activities for GMLs) are supported as per agreed timelines and qualityProcess:Provide medical strategic insights & evaluation related to Bioplus portfolio. Contribute to the management of the marketing authorization dossiers of the current related portfolio. Act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries, and teams supported. Assist the assigned medical team in conducting comprehensive medical regulatory writing-needs analysis Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region Work with selected vendors when required within the region to deliver the required deliverables as per the defined process Assist all scientific communicationsStakeholders:Work closely with all stakeholders in regions/areas to identify medical writing needs and assist in developing assigned deliverables Liaise with the all department to ensure relevant & customized are delivered per expectationAbout you Experience: ?5 years of experience supporting international pharmaceutical companies: medical affairs, clinical development, pharmacovigilance with experience in at least one of the therapeutic areas - metabolism, diabetes and lipid, ophthalmology, pediatric, gynecology & internal medicineSoft skills: Stakeholder management; communication skills; and ability to work independently and within a team environmentTechnical skills: As applicable (Including but not limited to Medical operational excellence, time, and risk management skills. Excellent technical (medical) editing and writing skills)Education: Medical degree M.D. Pharmacology OR M.D./M.S. OphthalmologyLanguages: Excellent knowledge of the English language (spoken and written)Soft Skills Required:Excellent people management skillWell versed with MS Office, PowerPoint, and Data Analytics Tools.Excellent communication skillAnalytical and multitasking skill(Extensive traveling globally will be a part of the job role)Why Join Bioplus?Bioplus offers a unique opportunity to make a significant impact on global healthcare by shaping the commercial success of novel, life-changing therapies. As part of our team, you’ll collaborate with passionate professionals committed to improving patient outcomes worldwide.What We OfferOpportunities for professional development and career growth.A collaborative and innovative work environment.Equal Employment Opportunity (EEO)Policy: Career opportunities at Bioplus are provided without discrimination on the basis of race, sex/gender, religion/caste/creed, social or ethnic origin, colour, age, differently abled (including physical medical conditions), sexual orientation, domestic partnership status, gender identity or expression, marital status, ancestry, genetic information or any other reason prohibited by laws in India. For more details, please visit our career website at https://bioplus.in/careers/ or email at talent@bioplus.in
