Pfizer Associate II, Medical Writing in Shanghai, China
Preparation, review and finalization of CSRs or related documents
Collaboration with biostatisticians and clinical colleagues to interpret study results and ensure timely and accurate integration of data presented in the statistical tables and listings and other information sources into the CSR
Active participation on clinical study teams in the development of clinical study documents
Ensure that all medical writing deliverables are prepared according to International Conference on Harmonisation (ICH) and other relevant regulatory guidelines
Ensure documents are generated in accordance with agreed internal processes and standards (eg Pfizer Global Document Style Guide), are submission ready and appropriately stored in an agreed document management system
Ensure that appropriate quality control (QC) checks are performed on CSRs, other regulatory documents and other medical writing deliverables, as required
Provide thorough and critical review or peer QC support, of documents prepared by others, as needed
Ensure own work processes are constantly improved to reflect lessons learned from previous experiences
May participate in CRDC initiatives to increase efficiency and productivity
Internally to Pfizer the Medical Writers have strong working relationships with:
PoC medical writers at the commissioning site
Programmers and PoC Programmers
Clinical study managers
Clinical project managers
Quality assurance auditors
ESSENTIAL CHARACTERISTICS 基本要求
At least bachelor degree or equivalent in medical related or life sciences.
Knowledge/experience of preparing ICH E3 compliant study reports or medical regulatory documents as a medical writer within or for the pharmaceutical / healthcare / regulatory industry
Excellent verbal and written English language skills
Demonstrable ability to communicate clinical data succinctly, clearly and accurately in writing, in English
Knowledge of ICH guidelines and regulatory requirements and demonstrable ability to interpret and apply these guidelines in a report writing setting
Basic knowledge of using Windows OS, MS-Word, MS-Excel, E-Mail (MS-Outlook)
Basic experience of working in electronic document management systems.
Demonstrable excellent interpersonal and team-working skills exhibiting active listening skills, influencing skills and professional behaviors
A balanced approach to problems, using flexibility and persistence as appropriate
Assertive with good influencing skills
Ability to deliver within agreed timelines and monitor / communicate progress against agreed milestones
Ability to work in a matrix organization with people in cross-functional lines and scientific staff from a range of disciplines
Ability to work effectively in a multi-cultural context.
Demonstrated ability to work effectively under pressure
Attentive to detail
DESIRABLE CHARACTERISTICS 希望具有的特征
Post-graduate degree (Masters) or education from universities overseas.
Ability to present with similar ease to both scientific and non-scientific audiences.
Expertise of interacting with cross functional study teams
Experience of writing Phase 1 to 4 clinical study reports as a medical writer in the pharmaceutical/healthcare industry for at least 2 years.
Demonstrable communication skills in a variety of media settings (e.g. teleconference).
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.