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Clinical Writing Specialist

  • GE Healthcare
  • Experienced
  • Posted 12/7/2017 10:48:40 PM
  • 3039204
  • Job Function: Engineering/Technology
  • Business Segment: Healthcare Technology & Medical Innovation
Location(s): United States; Wisconsin; Waukesha


About Us:
GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Role Summary:
This role supports in writing activities for conduct of clinical trials, including all protocol, reporting, consent documents, and supporting documents for a clinical project. This role has the responsibility to support the project team to achieve quality results in a cost-effective timely manner and the execution of assigned clinical trials from protocol concept through to clinical study report, in compliance with international GCP guidelines/regulations and policies and procedures.

Essential Responsibilities:
• Collaborates closely with CAPM’s and Senior Clinical Writers, cross-functional study teams and all Research partners, internal and external to GEHC
• Responsible for the writing and editing of medical documents, ensuring adherence to regulatory guidelines and departmental editorial standards.
• Assists the clinical project teams in project related activities, such as supporting regulatory documents and timelines.
• Coordinates and participates in study team meetings and drafts supporting documentation.
• Reviews and tracks clinical trial required documentation, and required regulatory documents and internal GEHC documents
• Assists in the planning and preparation for investigator meetings, regulatory meetings, and global issues.
• Some travel may be required

Qualifications/Requirements:
1. Associates degree (or internationally recognized equivalent.)
2. Minimum of one year’s administrative support experience.
3. Proficient in E-mail, Word, Excel, PowerPoint and Windows applications.

Desired Characteristics:
1. Bachelor’s degree (or internationally recognized equivalent) in a life sciences related field or R.N.
2. Advanced capabilities in E-mail, Word, Excel, PowerPoint and Windows applications.
3. Clinical Research experience such as: study site research coordination or management; sponsor-level clinical research project team experience. Other experience may include investigator qualifications; study monitoring; Clinical QA Auditing and/or Clinical Data Management within the pharmaceutical or medical device industry. (Medical Device research preferred.)
4. Project management experience including the ability to prioritize, plan & evaluate deliverables; is well organized and structured, strong attention to detail.
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. Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner.

Locations: United States; Wisconsin; Waukesha

GE offers a great work environment, professional development, challenging careers, and competitive compensation.  GE is an Equal Opportunity Employer.  Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditional upon the successful completion​ of a background investigation and drug screen.


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