Thermo Fisher Scientific
Regulatory Publishing Specialist (Advanced Word Formatting)
Thermo Fisher Scientific, New York, New York, United States
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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 (i.e. ISIToolbox), publishing systems (i.e. docuBridge, Veeva Submission Publishing), 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 multi task 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
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.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
Environmental Conditions
Office
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 (i.e. ISIToolbox), publishing systems (i.e. docuBridge, Veeva Submission Publishing), 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 multi task 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
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.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.