Manager/Sr. Manager Medical Affairs-Hyderabad

Job Description

Role & responsibilities 1. Development and review of clinical documents including protocol, investigator's brochure, case record form, product rationale, prescribing information, drug interactions and clinical study reports etc 2. Prepare CSRs revisions, IB updates, protocols, protocol amendments etc 3. Development and review of medical rationale for CT waiver applications 4. Support SEC meetings for clinical trials and marketing approvals by preparation of presentations & literature search 5. Work with the study biostatistician to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents 6. Works closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources. 7. Works closely with the study team to reach consensus on timelines for deliverables 8. Completes documents according to agreed-upon timelines and follows up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance 9. Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes 10. Ensuring that the content, format and structure of clinical documents comply with regulatory, journal, or other guidelines 11. Reviewing and proofreading materials to check quality and scientific accuracy 12. Ensures documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in agreed document management system 13. Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements. Additional responsibilities 1. Development and review of clinical and non-clinical overviews and summaries of CTD 2. Development and review of marketing requests of product evaluations, comparative safety and efficacy evaluations 3. Develop manuscripts, abstracts, and PowerPoint slide decks based on in-house studies and to support marketing team. 4. Mentoring/ training team members to gain required skills to enable on-time deliverables 5. Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed 6. Understands the functions and roles within the study team and aligns with them in delivery of documents to meet project-related goals and to meet external results disclosure obligations