Work Schedule

Environmental Conditions

Job Description

Summarized Purpose:

Provides experienced strategic, 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

Provides expertise in client submission deliverables supporting regulatory compliance.

Prepares components of electronic regulatory submissions that meet the electronic document requirements set by regulatory guidance, publishing documents and submissions that work with sponsor and/or regulatory agency software programs, and meeting consistency and security issues, under general supervision of the Manager, Electronic Publishing.

Maintains document life cycle for submission documents.

Leads the development and implementation of project-specific processes for sponsors with unique technology requirements.

May act as the company's liaison for regulatory submission with the sponsor and assist the company's project teams in executing regulatory submission strategies.

Provides leadership by participating in training, skill development, and mentoring of other electronic submission personnel, as needed.

Uses professional judgment to evaluate 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 or as the project team lead to evaluate and deliver publishing tasks.

Job Complexity

Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.

Job Knowledge

A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is the fully qualified, career-oriented, journey-level position.

Supervision Received

Normally receives little instruction on day-to-day work, general instructions on new assignments. Demonstrates good judgment in selecting methods and techniques for obtaining solutions.

Business Relationships

Represents the department as a prime contact on projects. Interacts with internal and external personnel on significant matters, often requiring coordination between functional areas. Networks with senior internal and external personnel in own area of expertise.

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 5+ 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:

Strong knowledge of regulatory requirements and guidances for document management and electronic submissions

Advanced knowledge of Microsoft (MS) Word, MS Excel, Adobe Acrobat, electronic document management systems, document publishing tools, publishing systems, eCTD validation and viewing tools

Advanced 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

Advanced organizational skills and effective interpersonal skills

Advanced analytical ability and problem-solving capabilities

Strong knowledge of medical terminology, statistical concepts, and guidelines and requirements of the FDA and other international regulatory agencies

Advanced 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.