• 招聘类型：社招
• 工作性质：全职
• 职位类别：销售类

职位描述

• Works closely with clinical study team to establish strategy, time lines, and project management for the reporting of clinical study data
• Collaborates with clinical study team members to interpret study results and prepare Clinical Study Reports (CSRs) and related documents
• Works closely with biostatisticians and clinicians to ensure study analysis results and statistical interpretations are accurately and clearly reflected in the CSR
• Manages all aspects of CSR production and ensures timely project delivery
• Ensures final CSRs conform to ICH-E3 guidelines and the Pfizer Global Document Style Guide
• Ensures ‘public disclosure’ related components of CSRs are finalized to enable timely release of results into the public domain
• Collaborate with clinical study team members to prepare clinical protocols
• Write or help write clinical and regulatory documents to enable global and China regulatory submissions (IND, CTA, NDA/BLA/MAA, briefing packages) in CTD format
• Write other clinical and regulatory documents including but not limited to patient safety narratives, basic results/public disclosure synopses, development-China-specific documents such as SARs, progress reports, subgroup analysis CSRs, bridging reports, China study protocols and CSRs, China submission documents.

任职条件

Primary Responsibilities

• Prepares, edits, and finalizes CSRs or related documents
• Collaborates with biostatisticians and clinical colleagues to interpret study results
• Works with groups outside CPW, e.g. Regulatory, CSR Coordinator, Clinical Trial Disclosure Group, QA
• Participates actively in clinical study teams in the development of clinical study documents
• Understands the functions and roles within the study team and aligns with them in delivery of CSRs to meet project-related goals and to meet external results disclosure obligations
• Ensures CSRs accurately reflect the data presented in the statistical tables and listings and other information sources
• When required, prepares, edits and finalizes the protocol and any amendments in collaboration with team members (e.g., Clinician, Clinical Pharmacologist, Safety Risk Lead, Statistician).
• Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines
• Ensures documents are generated in accordance with agreed internal processes and standards (e.g. Pfizer Global Document Style Guide), are submission ready, and appropriately stored in agreed document management system
• Ensures that appropriate quality control (QC) checks are performed on CSRs and other medical writing deliverables
• Provides thorough and critical review or peer QC support of documents prepared by others, as needed
• Ensures ‘public disclosure’ related components of CSRs are finalized to enable timely release of results into the public domain
• Supports corporate audit and regulatory inspections through attendance of related inspection meetings and has thorough documentation procedures integrated into daily work practices so as to facilitate such inspections
• Develops and maintains knowledge of all applicable global regulations and guidelines, SOPs, and practices
• Ensures own work processes are constantly improved to reflect lessons learned from previous experiences
• Work with other group members to enable improved quality and consistent format of CSRs
• Participates in CRDC and CII initiatives to increase efficiency and productivity

may lead selected teams in these efforts

• Implement recommendations for improvements to the CSR process
• Align with department management to set strategy for meeting department goals
• When needed, write or help write other clinical and regulatory documents not mentioned above
• Technical Skill Requirements
• Excellent verbal and written English language skills
• Demonstrates understanding of clinical data and has ability to communicate it succinctly, clearly, and accurately
• Knowledge of ICH guidelines and regulatory requirements and demonstrable ability to interpret and apply these guidelines in a report writing setting
• Ability to guide others in application of internal or regulatory guidelines
• Demonstrated excellent project management skills
• Basic knowledge of using Windows OS, MS-Word, MS-Excel, and MS-Outlook
• Basic experience of working in electronic document management systems
• Qualifications
• At least BS or equivalent in the medical or life sciences field
• Good understanding of pharmaceutical R&D processes
• Knowledge of global regulations and guidelines (FDA, ICH) and regulations of China and other Asian countries that pertain to the drug development process and production of CSRs
• Experience in interacting with cross functional study team members
• Experience in preparation of ICH E3-compliant CSRs within the pharmaceutical industry
• Demonstrates good communication skills in a variety of media settings (e.g. teleconference).
• Ability to present with ease to both scientific and non-scientific audiences
• Attentive to details
• Demonstrates strong interpersonal skills and has the ability to work in a multi-cultural environment
• Ability to communicate professionally with cross-functional lines, scientific staff from a range of disciplines, and all levels of management
• A balanced approach to problems, using flexibility and persistence as appropriate
• Ability to deliver within agreed timelines and communicate progress against agreed milestones
• Ability to multi-task and work effectively under pressure

demonstrate excellent project management skills

• Ability to work independently with minimal supervision

Demonstrated ability to focus on the customer, while setting realistic expectations for them

职位要求

• 学历要求：无
• 工作经验：无
• 外语要求：不需要