QPS Holdings, LLC
Medical Writer IV
|Post Date:||Jul 12, 2018||Type:||Full-Time|
|Start Date:||7/12/2018||Salary:|| |
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.
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.
- 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
- Collaborate with
Department Head and Project Managers in the timeline and milestone management
of on-going projects throughout the project lifecycle.
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.
in/assists with client visits, pre-qualification audits and regulatory audits;
assists lesser trained writers in these activities.
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.
familiarity with current industry practices and regulatory requirements that
affect medical writing.
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 of GCP,
ICH, and FDA regulations.
- Knowledge of
clinical drug development and approval processes.
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.
ability to work well in a team environment including ability to employ 'active
medical writing skills.
capabilities in publishing skills as pertains to clinical protocols and
integrated clinical study reports.
- 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.
to have previous pharmaceutical or CRO industrial experience in the area of
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.
QPS Holdings, LLC
Name: Nina Gaskin-Wyatt
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