Publishing Consultant

Greetings!!!
Welcome to TechProjects. We specialize in IT system integration, supporting major public sector clients across New York State. Our focus is on delivering high-quality technology solutions while creating strong career opportunities for our employees.
We are currently hiring and looking for talented tech professionals who are eager to work on impactful and innovative projects. We offer competitive compensation, excellent benefits, and opportunities for professional growth.
We look forward to connecting with you and exploring how you can be a part of our team. 
 
Job Title: Publishing Consultant Location: Remote Duration: Long term 
Description of Role and Responsibilities

• Responsible for managing a team

• Liaise with relevant stakeholders to ensure submissions are accurate and in-line with in-country requirements.

• Use technical tools to publish submissions in the correct format to be submitted to the Health Authority.

• Perform submission build activities, including, but not limited to, ensuring submissions are built with submission ready documents, creating inter-document links, performing quality checks and validating compiled submissions, and finalizing submission by required dispatch date.

• Review documents for submission-readiness and conformity to FDA regulations and guidelines.

• Consistency between documents and with document templates.

• Conform to health authority regulations, company SOPs, local working instructions and role specific training relevant to regulatory operations.

• Ability to quickly learn and master technical submission building and management software, responding actively to required changes in regulatory guidance.

• Utilisation of submission forecasts to proactively plan submission workload and identify areas to support team members in times of higher workload

• Publishing and performing technical validation (eCTD/CTD/NeeS/Paper)

• Performing final technical quality review.

•  Dispatching submission to the relevant authority ((eCTD/CTD/NeeS/Paper) or affiliate so that affiliate can dispatch to authority;

•  Performing post-submission processing activities such as receiving acknowledgment from authority of submission receipt; capturing and the electronic receipt and metadata in RIM; communicating submission receipt to key stakeholders

 Desired Skill Set:

• Strong Interpersonal Skills (Excellent verbal and written Communication, Problem solving, coordination etc.)

• Flexible and adaptable to change with vision for process improvement

• Attention to detail

• Effective time management and organizational skills

• The ability to meet tight deadlines and client management skills

• Technically adept using IT systems and software (Microsoft Office)

• Fast learner with proven ability to quickly understand overall changing demands of Projects

• People management skills

 Desired Experience:

• Clinical research experience is desirable

• Knowledge of ECTD/CTD/NEES/Paper types of submission, industry-standard publishing systems.

• 2 years of people management / team lead experience 

 
Required Qualifications:

1. Pham/M.Pharm/Science Graduate/ Life Sciences or related field is must
    

 Experience :
7-9 years experience in the Pharmaceutical Regulatory Industry/ Submission Management/ Publishing / eTCD