MedZilla

ExecuPharm is a Global Functional Service Contract Research Organization, certified by the Women’s Business Enterprise National Council (WBENC), who provides clinical research support services for the pharmaceutical industry. ExecuPharm’s distinctive business model incorporates flexible models of service and technologies to support every aspect of a clinical trial.

Position Purpose: The Early Development Clinical Technical Editor (ED CTE) will coordinate and perform the Client’s Quality Control (QC) process for clinical documentation that includes, but is not limited to, clinical protocols, investigator brochures, clinical study reports, patient narratives, and clinical modules of the common technical document; oversight of external resources for QC may be required.

Primary Duties:

Ensure documents comply with appropriate ICH and regulatory guidance

Work collaboratively with internal and external medical writers, regulatory publishers and project team members to deliver high quality clinical documentation in a timely manner

Proofread, review and edit clinical documents in support of clinical development projects in multiple
therapeutic areas and at various stages of development according to the Client’s SOPs and guides to verify:

• Completeness and accuracy of information

• Accurate use of grammar and style
• Consistency of text with internal document data displays as well as external reference sources;
• Application of format standards for electronic documents
• Compliance with submission-ready standards
• Consistent QC and good document practices across internal authors, vendors, and external
• partners
• Security and version control

Support the development, implementation and periodic review of editorial management procedures

Training and Education:

·        BA/BS required with 2 years of pharmaceutical industry experience, specifically within a clinical development operations function, and previous hands-on work with regulatory submission documents

·        Experience with regulated scientific/clinical documentation in a pharmaceutical, biotech, or clinical research environment

·        Demonstrated skill in quality control of documentation and/or technical editing

·        Excellent written English skills

·        High degree of organization and able to manage multiple projects at any given time

·        Attention to detail and committed to excellence in all aspects of their work

·        Ability to work under pressure, and to work independently and collaboratively with teams

·        Excellent communication and interpersonal skills, and ability to maintain a positive attitude under pressure

·        Advanced Microsoft Word skills (including the use of electronic Word templates) and Adobe Acrobat Experience in the use of a Doc base system or similar Electronic Document Management system

ExecuPharm's client is a major pharma company. This is a work from hom position.

Salary range is 80-90K, plus paid time off and a full benefits package.