Syed Yasin

• Conduct and manage QC activities on deliverables produced by the aggregate report analysts to meet required quality expectations.
• Provide support & training to new joiners in the QC team.
• Manage special projects and requests as per request.
• Cross-trained existing employees to maximize team agility and performance.
• Serve as a QC SME assist in managing team deliverables and measuring quality metrics.
• Support regulatory instruction and internal audit.

• Independently write clinical study reports and other regulatory documents according to company or client-specified formats.
• Independently write patient narratives for serious adverse events and drop-outs due to non serious adverse events.
• Managing all aspects of Medical Writing department including, but not limited to:
  o Supervise and provide general assistance to medical writing team.
  o Organize and maintain medical writing work schedule.
  o Assign suitably experienced medical writers to projects.
  o Liaise with Sponsors, clinical project managers, and new business personnel with regard to availability of medical writing resources and establishment of project timelines.
  o Obtain project progress reports from senior medical writers and use this information to ensure maintenance of document quality and project timelines.
  o Review documents prepared by medical writing team.
  o Liaise with clinical project managers, Data Management, Biostatistics, and QA to ensure maintenance of document quality and project timelines.

Periodic Safety Update Reports (PSUR),Periodic Adverse Drug Experience Reports (PADERs), AdHoc Reports, Safety Update Reports (SUR), Literature Review

• Development of documents pertaining to post-marketing safety data to support product development, license application, and post-marketing maintenance, on behalf of and in conjunction with corresponding project teams. Documents worked on include above mentioned.
• Support teams by providing analyses of clinical data, post-marketing safety data, reviews of medical literature, and similar related activities.
• Collaborate with quality lines and relevant project team subject matter experts, ensuring accuracy and quality of information presented in assigned documents.
• Identify potential areas for process improvements and possible solutions, and communicate these to line management or appropriate functional line.
• Review of literature of potential Individual case safety reports (ICSRs), aggregate reports and signal detection.

• Preparation of safety aggregate reports (DSURs) which includes scheduling planning meetings and authoring of reports and literature review for ICSRs, safety signal detection and articles for aggregate reports.
• Review of literature of potential Individual case safety reports (ICSRs), aggregate reports and signal detection. Import literature to central repository. Annotate dispositions of review within repository. Forward potential ICSRs to case management centres.
• Perform Quality check/ annotation on review and assessment of articles. Provide outputs to internal and external groups (eg: product safety evaluation) as requested.
• Responsible for literature review and identification of potential adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations and corporate policies.

Clinical Study Reports (CSR), Clinical Study Protocols, Informed Consent Forms (ICF)

• Six years of experience in providing Scientific Writing support to Phase III and post marketing surveillance vaccine clinical trials and epidemiological trials.
• Development of clinical trial documents such as CSRs, Protocols and ICF.
• Perform quality checks on each report for compliance, template instructions and content to ensure flawless reports for review.

Recruitment, Mentoring and Coaching

• Involved in recruitment & training of new recruits to the Scientific writing team. Provided adequate training and support to protégé's to develop a quick and good understanding of the project nuances to become independent at the earliest after commencement of the mentoring/coaching phase.
• Initiated a Training and Development Team to help trainee writers.

Global process improvement initiatives

• Member of Operational Excellence Team developing global templates for Post Marketing Surveillance (PMS). Contributed by interacting with global team to author the simplified model informed consent form template for PMS.