Description

Job Description : Drafting of Module 2.5 and 2.7 for INDs, NDAs, BLAs, MAA and other regulatory submissions. Drafting of clinical sections for Investigators Brochure (IB). Drafting of clinical study protocols and Clinical study reports (CSR) Drafting of clinical sections for Brifing Books and meeting packages including meeting presentations. Perform critical review of clinical documents for consistency of information and messaging withing clinical modules. Provide appropriate review feedback to authors and other stakeholders. Handling of regulatory queries related to any clinical issues or matters of concern Internal project planning and assignement of tasks to team members including appropriate guidance in the day to day activities. Discuss and coordinate with other stakeholders (CMC and Non-Clinical Writing) on important aspects including the consistency of information/messaging. Extensive communication with clients and other internal stakeholders on project status and updates. SKILLs SET REQUIRED: In depth understanding of eCTD structure and regulatory requirements specific to clinical modules Good knowledge in literature search and reviewing the suitable articles from different databases Good leadership qualities and handling of conflicts. Good verbal and written communication skills. Client communications and internal project management QUALIFICATION: MPharm, MS Pharm, Pharma D, PhD or Any other master's degree in science. EXPERIENCE: 7+ years of experience in regulatory toxicology and clinical writing Hands on experience in handling of clinical documents for eCTD

Role and Responsibilities

• Job Description : Drafting of Module 2.5 and 2.7 for INDs, NDAs, BLAs, MAA and other regulatory submissions. Drafting of clinical sections for Investigators Brochure (IB). Drafting of clinical study protocols and Clinical study reports (CSR) Drafting of clinical sections for Brifing Books and meeting packages including meeting presentations. Perform critical review of clinical documents for consistency of information and messaging withing clinical modules. Provide appropriate review feedback to authors and other stakeholders. Handling of regulatory queries related to any clinical issues or matters of concern Internal project planning and assignement of tasks to team members including appropriate guidance in the day to day activities. Discuss and coordinate with other stakeholders (CMC and Non-Clinical Writing) on important aspects including the consistency of information/messaging. Extensive communication with clients and other internal stakeholders on project status and updates. SKILLs SET REQUIRED: In depth understanding of eCTD structure and regulatory requirements specific to clinical modules Good knowledge in literature search and reviewing the suitable articles from different databases Good leadership qualities and handling of conflicts. Good verbal and written communication skills. Client communications and internal project management QUALIFICATION: MPharm, MS Pharm, Pharma D, PhD or Any other master's degree in science. EXPERIENCE: 7+ years of experience in regulatory toxicology and clinical writing Hands on experience in handling of clinical documents for eCTD