北京招聘

Business Segment

Healthcare Science Technology

Role Summary/Purpose

The Clinical Writer partners with Subject Matter Experts, Medical Directors and clinical team to create clinical study related documents in accordance with ICH, regulatory authority, and/or GEHC guidelines. Creates a variety of clinical documents for all phases of clinical research by organizing, analyzing, and interpreting scientific and statistical data. Assists with regulatory submissions and will conduct medical literature searches as required.

Essential Responsibilities

1. Create clinical study related documents in accordance with ICH, regulatory authority, and/or GEHC guidelines including: clinical study reports, study protocols, informed consent forms and other clinical documents as applicable.
2. Works with manager and Clinical Affairs Project Manager to ensure research activities are run compliantly and according to project timelines.
3. Attend internal and external meetings as necessary for each project (e.g., Project Kick-off meeting, Sponsor team meetings, Project team meetings).
4. Reviews statistical analysis plans and case report forms, as required.
5. Performs quality control (QC) review of clinical study protocols and other submissions written by other medical writers.
6. Work with Clinical Affairs Project Manager and other members of the study team on full service projects.
7. Conduct medical literature searches as required.

Qualifications/Requirements

1. Bachelor’s degree (or internationally recognized equivalent) plus a minimum of 5 years clinical research experience.
2. Clinical Research experience to include of all aspects of the clinical research process including a minimum of 3 years clinical writing experience within the bio- pharmaceutical or medical device industry. (Medical Device research preferred.)
3. Working knowledge of ICH and other regulatory guidelines.
4. Proficiency in Microsoft Word.
5. Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner.

Quality Specific Goals:
1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.

2. Complete all planned Quality & Compliance training within the defined deadlines.

3. Identify and report any quality or compliance concerns and take immediate corrective action as required

Desired Characteristics

1. An advanced degree, (Masters, PhD.) in life sciences.
2. Ability to travel 10% for job related responsibilities.)
3. Experience conducting medical literature searches, analyzing and writing reports on the results of such searches.
4. Knowledge of Quality Management Systems (QMS.)
5. Experience working across cultures/countries/sites.
6. Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.
7. Demonstrated ability to work well independently & in a team setting.
8. Strong problem solving, influencing and negotiation skills.
9. Project management experience including the ability to prioritize, plan & evaluate deliverables; is well organized and structured, strong attention to detail.
10. Demonstrated ability to work well in a team-oriented, collaborative environment.
11. Experience interfacing with Regulatory Agencies such as FDA, European competent authorities & notified bodies, Health Canada, SFDA, KFDA, MHLW, etc.

GE医疗集团提供革新性的医疗技术和服务，以满足需求，使全世界更多的人能以更可负担的成本获得更好的医疗服务。GE专注于世界至关重要的问题，以优秀人才和领先技术致力于应对行业重大挑战。GE医疗集团在医学成像、软件和信息技术、患者监护和诊断、药物研发、生物制药技术、卓越运营解决方案等多个领域，助力专业医务人员为患者提供优质的医疗服务。