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QPS Holdings, LLC

Medical Writer IV

Post Date:Jul 12, 2018Type:Full-Time
Start Date:7/12/2018Salary:
Location:US-DE-Newark Job Reference:qpsllc-DTP3-1009
Skills:
 

Job Description:

QPS, LLC is an innovative and dynamic Contract Research Organization (CRO) that has been assisting pharmaceutical, biotechnology, and medical device companies with their drug development efforts by providing a full range of GLP-compliant bioanalysis, DMPK, and protein/genomic biomarker services since 1995.  Please visit our website (www.qps.com) for more information and to see all current openings.

Job Summary

The Medical Writer IV serves as a writer for clinical study reports, protocols, investigator brochures, posters, manuscripts, or other clinical and regulatory documents.  This position is responsible for establishing quality procedures necessary for the Medical Writing function. The incumbent will contribute to the success of Clinical Research Services by supporting the Department Head and Project Managers (PM) in management of timelines and milestones of on-going projects throughout the project life-cycle. 

Essential Functions

  • Develop, implement, and maintain policies, procedures, methods, standards and templates for the medical writing function globally to support clinical research studies.
  • Recommends actions to ensure compliance with industry regulations and client expectations.
  • Interpret clinical study results, and ensure writing assignments meet standards of order, clarity, conciseness, style, and terminology.
  • Leads Medical Writer teams in drafting report and document specifications.  Assists in the development and preparation of formats, templates, and SOPs for clinical study reports, protocols, investigator brochures, posters, manuscripts, or other clinical and regulatory documents.
  • Collaborate with Department Head and Project Managers in the timeline and milestone management of on-going projects throughout the project lifecycle.
  • Solicits and obtains study-related data and information from all sources, scientifically interprets, analyzes,organizes and presents information in clear, concise manner to industry style and formattng standards.
  • Participates in/assists with client visits, pre-qualification audits and regulatory audits; assists lesser trained writers in these activities.
  • Develops and implements training of medical writers and provides in-service training as requested by other functional leaders. Explains regulations, rules, and policies upon which training is based.
  • Maintains familiarity with current industry practices and regulatory requirements that affect medical writing.
  • Assists in the implementation, coordination, execution and management of clinical research services using resources and counterparts globally in other QPS locations and where applicable be responsible for work being executed. 

Knowledge/Skills/Abilities

  • Knowledge of GCP, ICH, and FDA regulations.
  • Knowledge of clinical drug development and approval processes.
  • Excellent written and oral presentation skills to include knowledge of the structure and content of the English language including the meaning and spelling of medical terminology, standard words and phrases, rules of composition, and grammar.
  • Proven ability to work well in a team environment including ability to employ 'active listening' skills.
  • Demonstrated medical writing skills.
  • Advanced capabilities in publishing skills as pertains to clinical protocols and integrated clinical study reports. 

Education/Experience

  • MS/entry level MD, Ph.D. or Pharm.D. degree with > 7 years directly relevant Medical Writing experience with clinical protocols and/or CSRs and demonstrating necessary skill level; or Ph.D./graduate Pharm.D/MD degree with > 6 years directly relevant MW experience with clinical protocols and/or CSRs and demonstrating necessary skill level.
  • Required to have previous pharmaceutical or CRO industrial experience in the area of medical writing.
  • Experience interacting with regulatory agencies and clients 

QPS, LLC is an Equal Employment Opportunity/Affirmative Action Employer.  In accordance with federal, state, and local laws, we recruit, hire, promote and evaluate all personnel without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, citizenship status, physical disability, protected veteran status, or any other characteristic protected by law. Job applicants and present employees are evaluated solely on ability, experience, and the requirements of the job. In addition, QPS, LLC is a federal contractor and desires priority referrals of protected veterans. 





Contact Information
QPS Holdings, LLC
Name: Nina Gaskin-Wyatt


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