Regulatory Publishing Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Summarized Purpose :

Provides moderate, expedient, and efficient preparation of client electronic submission deliverables and dossier that meet current local, regional and ICH regulatory and technical requirements. Ensures successful regulatory review outcomes for product milestones. Serves in a quality review role and is responsible for the thorough review of documents created within or outside of the company to ensure quality of standards meet or exceed client expectations.

Essential Functions and Other Job Information :

Essential Functions

• Coordinates and manages client electronic submission deliverables supporting regulatory compliance.
• Assists in preparing electronic document outputs that meet requirements for regulatory publishing to include documents that work with sponsor and / or regulatory agency software programs meeting consistency and security issues.
• Ensures that all final electronic deliverables meet current regulatory electronic document requirements and guidance under general supervision of the Manager, Regulatory Publishing and assistance as appropriate from a Senior Regulatory Publishing Specialist.
• Assists with developing and implementing project-specific processes for sponsors with unique technology requirements and may act as the company's liaison for electronic submissions with the sponsor.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Evaluates the publishing needs in relationship to the overall project timelines, quality and delivery.
• Engages other project team members, functional units or publishing management as necessary to deliver final product and resolve / mitigate identified issues or barriers to delivery.
• Acts independently within a project team to evaluate and deliver publishing tasks.

Job

Complexity

Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.

Job

Knowledge

Developing professional expertise, applies company policies and procedures to resolve a variety of issues.

Supervision

Received

Normally receives general instructions on routine work, detailed instructions on new projects or assignments. Exercises judgment within defined procedures and

practices to determine appropriate action.

Business

Relationships

Contacts are primarily internal to the company with infrequent external customer / vendor contact on routine matters. Builds productive internal / external working relationships.

Qualifications :

Education and Experience :

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

In

some

cases

an

equivalency,

consisting

of

combination

of

appropriate

education,

training

and / or

directly

related

experience,

will

be

considered

sufficient

for

an

individual

to

meet

the

requirements

of

the

role.

Knowledge, Skills and Abilities :

Management Role :

No management responsibility

Physical Requirements :