Position Summary

Strategy & Analytics – Therapeutic Area Transformation Strategy

At Deloitte’s USI S&A team, we are looking for Consultants / Senior Consultants, with relevant experience in regulatory affairs, medical writing for new molecular entity submission dossiers.

The Strategy and Analytics Offering Portfolio helps clients achieve breakthrough value by developing integrated strategies to win in their chosen markets and by architecting data driven programs that transform their business.

Strategy: Therapeutic Area Transformation

The healthcare and life sciences industry has long been viewed as the place where innovation is commercialized: research and development pipelines produce products with increasing therapeutic benefits that then fuel exponential growth of pharmaceutical and biotechnology companies across the world and change broader healthcare.

But the environment has changed and manufacturers can no longer play successfully across all therapeutic areas due to:

• Less efficient and less productive pipelines
• Expiry of blockbuster products and growing competition
• New care models resulting in a shift in decision makers and centers of influence
• Reduced access to customers and changing modes of and types of interactions
• Evolving science and comparative effectiveness

Healthcare and life science companies must constantly stay on top of the needs of the marketplace to avoid pitfalls or else miss important opportunities. As a result, manufacturers are being forced to rationalize and rebalance their portfolios to better compete. Yesterday’s approach of owning and commercializing a promising product in a new therapeutic area with limited experience and no future pipeline strategy is no longer a safe bet. The LSHC industry is full of cautionary tales from manufacturers that thought having positive clinical data and an unmet medical need were enough to succeed and providers have experienced this not to happen while payors are weary of high drug cost.

Deloitte’s Therapeutic Area Transformation Practice provides a unified market, pursuit or offering for clients or pursuits that need a TA based focused (e.g., diabetes, oncology, immunology, neurology) to be effective in improving cost, quality, access and value to patients

Work you will do : Deloitte’s ‘Strategy’ service line helps companies address the entire range of top management challenges including pursuing new growth opportunities, developing go-to-market strategies, channel strategies, and pricing strategies.

• Develop client deliverables and documentation:
• Develop standardized content for submission dossiers, along with data-standards
• Analyze and interpret project data, draw conclusions and develop recommendations based on the result of the specific outputs
• Strive to improve deliverable quality through QC verification and validation of outputs
• Act as the Subject Matter Advisor (SMA) for relevant projects
• Conduct KOL/Client/SME interviews, participate in workshops and training sessions, and present recommendations
• Assist in developing proposals and collateral
• Job Location : Bangalore, Gurgaon

Office Timings : 11 AM to 8 PM

Required Experience

• Experience in medical writing or regulatory affairs
• Experience working on submission dossiers in clinical, Chemistry, Manufacturing & Control (CMC), labelling or pre-clinical domains
• Experience working with health authorities ( knowledge of global, regional, national and other document development guidelines)
• Experience working in the pharmaceutical/CRO industry
• Understanding of Regulatory Information Management systems as a plus
• Demonstrated experience in writing or contributing to scientific publications as a plus.
• Excellent written, verbal and presentation skills along with top-tier communication and listening skills
• Strong grammatical, editorial and proof-reading skills
• Exceptional interpersonal, team building and communication skills (both internally and with clients)
• Tolerance for working in ambiguous, uncertain, autonomous environments
• Commitment to personal and professional growth

Required Qualifications

• PhD/MD/MS/M. Pharma/B. Pharma from a premier school in India or abroad is preferred.
• Qualifications in medical writing such as AMWA,EMWA, RAC desired
• Minimum 2+ years of relevant experience
• Hands-on exposure working in the Life Sciences (Pharmaceutical / Biotech), CROs, or health authorities (e.g., FDA, EMA etc.) is desired
• Understanding and experience in Oncology would be a plus

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Requisition code: 55854

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