As Head of Medical Affairs, I am responsible for running the Medical Department, covering areas such as, Pharmacovigilance, Support to Marketing Department (to ensure compliance of medical and ethical standards in promotional materials review, product presentation, scientific events management etc.), Support to Regulatory Division for scientific and ethical information, Product Complaints, Customer Interactions (including renowned KOL, Patients queries etc.), Education of both internal and external customers and Trainings (relevant stakeholders). Responsibility also includes the overall management and execution of clinical trials (including NIS & BE studies) to meet all ethical, regulatory and international standards for each study protocol. Implementation of Standard Operating Procedures, Training of clinical trial staff (including investigator) on ICH-GCP, Adverse Event reporting management; to ensure that safety responsibilities are continually being maintained and implemented in the Medical Department. Having diversified exposure and experience of business development, Medical and Regulatory management practices (ICH-GCP guidelines, relevant applicable regulatory guidelines), Compliance & Marketing Ethics of marketing and field personals (IFPMA code of ethics), Medico-Marketing Analysis and Liaison with National & International business partners. Develop and maintained professional relationship with KOL and clinical Investigators and also ensure that the Medical Department is continually updating the product and disease knowledge sales and marketing colleagues. Active and permanent member of Highnoon leadership team for the development of short and long term strategies, policies and utilization of resources for company growth and business.

Responsibility included management of the ALTTO study trial at all sites across Pakistan and I was the primary contact for the Investigators as well as global study management for resolving all their queries and concerns. Successfully organized and managed ALTTO study audits for two sites in Pakistan with neither site audit having critical or major findings. I also supported and provided advice in setting up Bioequivalence studies at Karachi University. Responsibility also involved quality review visits for all studies and I personally created / managed Corrective & Preventive Actions (CAPA) of any identifiable issues at the time of quality review visit.

Responsible for fulfilling local as well as international regulatory guidelines (e.g. ICH-GCP) for the management of all clinical projects. Work closely with all stakeholders (investigators, drug Regulatory Authority members, hospital staff, key opinion leaders and study managers) for execution and implementation of each study project. Designed and developed study related materials; SOP’s as well as manages a team of CRA for their respective studies.

Oversee the execution of clinical trials and organize & conduct clinical staff training. Analyzed and developed action plans to address issues with study monitors, sponsors and regulatory agencies. Ensured clinical trial activities were conducted in accordance with the Protocol, SOP, ICH-GCP and applicable regulatory requirements. Ensured the accuracy of the generated data in accordance with protocols, ICH-GCP and requirements of applicable regulatory agencies. Wrote, revised and approved SOPs and other internal procedures. Participated in project scheduling, assessing and establishing project milestones. Reviewed and approved scheduling and task assignment for clinical research staff and responsible for scientific / medical support in the preparation of dossiers to Ministry of Health. Responsible for the safety documentation and handling of medical complaint/queries of company products.

Responsible for audit / re-verification of RECORD 4 (REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE) data in accordance with source documents, Parexel International SOPs and in accordance to ICH-GCP guidelines. Managed and resolved e-CRF Queries (edit checks), according to outlined procedures in the e-CRF Completion Guidelines.

Efficiently and effectively managed Phase I, Phase II, Phase III and Phase IV clinical trials. Responsibilities included core study start up activities, monitoring, close out, IP accountability, AE/ SAE management. Accompanied visits with my team members to ascertain that their monitoring met international standard, internal SOPs, study protocols and ICH-GCP guidelines. Responsible for managing study feasibility for all newly assigned projects including regular follow up with study management for country allocation. Budgeting according to head accounts such as EPE Consultant Clinical, Advisory Board Attendees fee, Investigator Grant Payment, Clinical Trial Patient expenses, Study Subject Reimbursement, Clinical Trial Supplies (CTM), EPE Shipping costs, CRO management fees, Equipment Lease / Purchase, Investigator Meeting fee, Site Monitoring costs, Medical Writing etc.) Continuous review of the performance of the team as a whole in order to identify areas where quality and efficiency can be improved. Complete quality review of site and documentation. Proven ability to work with and resolve issues in a timely manner with the Ministry of Health, hospital staff, key opinion leaders and study management.