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Medical Writer 2
ITHACA NY 14850
Category: Pharmacist, Health Care Industry
  • Your pay will be discussed at your interview

Job code: lhw-e0-90661159

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IQVIA

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Summary

  Job posted:   Thu Jun 7, 2018
  Distance to work:   ? miles
       
  1 Views, 0 Applications  
 
Medical Writer 2
**Description:**


**PURPOSE**



Prepares, or contributes to the preparation of more advanced or complex clinical documents, for either internal Quintiles



customers or external clients, for investigational drugs, biologicals, or medical devices, under the guidance of senior staff.



Participates in project teams and may lead specific tasks, consulting senior staff as necessary.





**RESPONSIBILITIES**




+ Acts as Lead Medical Writer on more advanced writing projects and performs competently, with guidance from senior staff

+ as required. Takes responsibility for preparation of assigned documents to a high standard, working in accordance with

+ Quintiles SOPs and the customer's requirements. Identifies project needs, tracks project timelines and implements client

+ requests with senior review.

+ Participates in both internal and external project team meetings and liaises directly with the customer on medical writing

+ issues, including setting of project timelines, as appropriate and with senior support as needed.

+ Arranges appropriate internal review of assigned documents and takes responsibility for on-time delivery.

+ May perform QC review of documents or parts of documents prepared by more senior staff.

+ May deliver basic level training to small groups or individuals within Quintiles on the role of the medical writer.

+ Takes responsibility for managing workload for assigned projects and tasks, in collaboration with senior staff.

+ Keeps abreast of current data, trends, medical writing/regulatory knowledge, developments and advances in area of drug

+ development/medical writing.

+ Complies with Company SOPs and participates in the implementation of new SOPs.





All responsibilities are essential job functions unless noted as nonessential (N).


**Qualifications:**


**REQUIRED KNOWLEDGE, SKILLS AND ABILITIES**




+ Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and

+ verbally.

+ Familiarity with the structural and content requirements of clinical study reports, protocols, and similar documents.

+ Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.

+ Competence in completing a good first draft clinical study report in any therapeutic area within a standard timeframe with

+ limited guidance, and ability to prepare a good first draft protocol, with senior guidance.

+ Good understanding of common statistical methods used in clinical trials and interpretation of their results.

+ Ability to give a presentation to a project team and/or customer on project-specific topics, e.g. on lessons learned.

+ Ability to identify deficiencies, errors, and inconsistencies in a protocol.

+ Ability to effectively review a statistical analysis plan.

+ Ability to identify deficiencies, errors, and inconsistencies in statistical output.

+ Confidence in building relationship with customer and discussing Medical Writing issues with customers in person or on

+ the telephone.

+ Can provide thorough, appropriate and sensitive feedback to peers upon request to review a document.

+ Ability to work on several projects at once while balancing multiple and overlapping timelines.

+ Ability to assess workload and suggest prioritization to senior staff.

+ Demonstrated abilities in collaboration with others and independent thought.

+ Knowledge of regulations relevant to medical writing.

+ Careful attention to detail and accuracy.

+ Must be computer literate.

+ Ability to establish and maintain effective working relationships with coworkers, managers and clients



**MINIMUM REQUIRED EDUCATION AND EXPERIENCE**




+ Bachelor's degree in a life science-related discipline, plus 2.5 years' experience as a medical writer within a

+ pharmaceutical environment; or equivalent combination of education, training and experience



**PHYSICAL REQUIREMENTS**




+ Extensive use of telephone and face-to-face communication requiring accurate perception of speech

+ Extensive use of keyboard requiring repetitive motion of fingers

+ Regular sitting for extended periods of time

+ Occasional travel



EEO Minorities/Females/Protected Veterans/Disabled


**Job Field:**


Technical & Regulatory Writing


**Primary Location:**


USA-New York-Ithaca

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