Pfizer Associate II, Medical Writing in Shanghai, China

KEY RESPONSIBILITIES

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

ORGANISATIONAL RELATIONSHIPS

Internally to Pfizer the Medical Writers have strong working relationships with:

PoC medical writers at the commissioning site

Clinicians

Biostatisticians

Programmers and PoC Programmers

Data managers

Clinical study managers

Clinical project managers

Document Specialists

Quality assurance auditors

ESSENTIAL CHARACTERISTICS 基本要求

Education学历要求

At least bachelor degree or equivalent in medical related or life sciences.

医学或生命科学大学本科及以上

Experience

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

Technical Competencies技术要求

Excellent verbal and written English language skills

Demonstrable ability to communicate clinical data succinctly, clearly and accurately in writing, in English

能够用书面简明,清晰,正确地进行临床数据方面的沟通

Knowledge of ICH guidelines and regulatory requirements and demonstrable ability to interpret and apply these guidelines in a report writing setting

熟悉ICH 指导方针和新药注册申报法规要求

Basic knowledge of using Windows OS, MS-Word, MS-Excel, E-Mail (MS-Outlook)

Basic experience of working in electronic document management systems.

Behavioural Competencies行为要求

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

根据事先制定的时限,能够提交完成的工作并监察进度

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.

具备在多元文化下有效地工作的能力

Demonstrated ability to work effectively under pressure

Attentive to detail

DESIRABLE CHARACTERISTICS 希望具有的特征

Education学历要求

Post-graduate degree (Masters) or education from universities overseas.

研究生或毕业于海外大学

Technical Competencies技术能力

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.

Behavioural Competencies行为能力

Demonstrable communication skills in a variety of media settings (e.g. teleconference).

具备远程电话会议沟通能力

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.