Work Schedule

Environmental Conditions

Job Description

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 a 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:

Working knowledge of regulatory requirements and guidances for document management and

electronic submissions

Strong knowledge of Microsoft (MS) Word, MS Excel, Adobe Acrobat, electronic document

management systems, document publishing tools, publishing systems, eCTD validation and viewing

tools

Strong knowledge of electronic templates and skilled in formatting and troubleshooting templates

Ability to manage several complex projects in parallel and adapt to changing priorities

Ability to exercise independent judgment in developing methods, techniques and evaluation of criteria

using defined procedures and practices

Ability to independently assess sponsor needs and work with project team members in producing

compliant deliverables

Ability to independently learn new technologies

Strong organizational skills and effective interpersonal skills

Strong analytical ability and problem-solving capabilities

Good working knowledge of medical terminology, statistical concepts, and guidelines and

requirements of the FDA and other international regulatory agencies

Strong editorial/proofreading skills

Detail-oriented, thorough, and methodical

Ability to create and follow timelines and conduct long-range planning

Ability to multitask performing numerous single or complex tasks without ignoring overall objectives

Ability to judge when to initiate changes and make final determinations in the presentation of data in

accordance with regulatory guidelines and reviewers’ comments

Ability to concentrate on the detail in a document without losing sight of the document as a whole

Management Role:

No management responsibility

Working Conditions and Environment:

Work is performed in an office/ laboratory and/or a clinical environment.

Exposure to biological fluids with potential exposure to infectious organisms.

Exposure to electrical office equipment.

Personal protective equipment required such as protective eyewear, garments and gloves.

Physical Requirements:

Ability to work in an upright and /or stationary position for 6-8 hours per day.

Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements

of the fingers, hands, and wrists.

Frequent mobility required.

Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.

Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop

computer with a maximum lift of 15-20 lbs.

Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

Ability to communicate information and ideas so others will understand; with the ability to listen to

and understand information and ideas presented through spoken words and sentences.

Frequently interacts with others to obtain or relate information to diverse groups.

Performs a wide range of variable tasks as dictated by variable demands and changing conditions

with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.

Regular and consistent attendance.