At Deloittes 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. Building on more than 175 years of service, our network of member firms spans more than 150 countries and territories. Together, Deloitte’s more than 330,000 people worldwide make an impact that matters.
Post : Medical Writer
Job Description
• 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
Candidate Profile
• 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
• 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
Additional Information
Experience : PhD/MD/MS/M. Pharma/B. Pharma
Qualification : 2+ years
Location : Bangalore, Gurgaon
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th October, 2021
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