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Regulatory Writer IV (Principal Regulatory Level)

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Job Details
Job Order Number
529271
Company Name
QPS, LLC
Physical Address
3 INNOVATION WAY # 240, Delaware Technology Park
Newark, DE 19711
Job Description

Summary
In compliance with goals, policies, and objectives established by the Department Head, serves as Principal Regulatory Writer and 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 Regulatory Writing function. The incumbent will contribute to the success of Clinical Research Services by supporting the Head of CRS and Project Managers (PM) in management of timelines and milestones of on-going projects throughout the project lifecycle. The Principal Regulatory Writer also coordinates with regulatory writers at other QPS sites and those managers or supervisors to help assure continued harmonization and provide training at the direction of the Department Head.
Essential Functions
o Develop, implement, and maintain policies, procedures, methods, standards and templates for the regulatory writing function globally to support clinical research studies.
o Recommends actions to ensure compliance with industry regulations and client expectations.
o Responsible for writing, reviewing/QC, and editing clinical study reports, protocols, investigator brochures, posters, manuscripts, or other clinical and regulatory documents with interpretation of clinical study results. Ensures writing assignments meet standards of order, clarity, conciseness, style, and terminology.
o Establish and maintain records and files of work and revisions including information in written or electronic/magnetic form.
o Leads Regulatory 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.
o Collaborate with Department Head of CRS and Project Managers in the timeline and milestone management of on-going projects throughout the project lifecycle.
o Performs on-line literature searches utilizing appropriate web-based search engines.
o Interacts with clients on ongoing and new projects in a role of clinical writer.
o Interacts with global Regulatory Writing staff to assure quality process and deliverables; provides training when required.
o 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.
o Confers with department and/or site heads to coordinate activities locally and globally.
o Participates in/assists with client visits, pre-qualification audits and regulatory audits; assists lesser trained writers in these activities.
o Develops and implements training of regulatory writers and provides in-service training as requested by other functional leaders. Explains regulations, rules, and policies upon which training is based.
o Maintains familiarity with current industry practices and regulatory requirements that affect regulatory writing.
o 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.
Competencies (“soft skills”, traits, behaviors – i.e., adaptability, analytical thinking, tenacity, initiative, results orientation)
o Conceptual and analytical thinking
o Results orientation
o Development orientation
o Concern for impact & concern for standards
o Flexibility
Knowledge / Skills / Abilities (i.e., knowledge of GLP regulations, operation of lab equipment, mathematical ability)
o Knowledge of GCP, ICH, and FDA regulations.
o Knowledge of clinical drug development and approval processes.
o 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.
o Advanced knowledge and skills with Microsoft Word, Excel, PowerPoint, and Acrobat.
o Proven ability to work well in a team environment including ability to employ ‘active listening’ skills.
o Demonstrated regulatory writing skills.
o Advanced capabilities in publishing skills as pertains to clinical protocols and integrated clinical study reports.
o Knowledge of principles and processes for providing customer service to clients (external and internal). This includes customer needs assessment, meeting quality standards for services and evaluation of client satisfaction. Also involves the ability to work well under pressure and tight timelines.
Education / Experience (minimum degree level and/or minimum number of years experience – including field of study and/or experience)
o MS/entry level Pharm.D. degree with > 7 years directly relevant MW 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.
o Required to have previous pharmaceutical or CRO industrial experience in the area of medical writing.
o Familiarity with GCP, ICH, and FDA regulations.
o Documented experience at Advanced level with Microsoft Word, Excel, PowerPoint and Adobe Acrobat, diplomas or certification attestations would be a plus.
o Knowledge of clinical drug development and approval processes.
o Experience interacting with regulatory agencies and clients
o Advanced capabilities with publishing tools in the creation of eCTD documents with linking, TOC creation and bookmarking.


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