REGULATORY PUBLISHING SPECIALIST

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionSummarized Purpose.
rovides moderate, expedient, and efficient preparation of client electronic submission deliverables anddossier that meet current local, regional and ICH regulatory and technical requirements.
Ensuressuccessful regulatory review outcomes for product milestones.
Serves in a quality review role and isresponsible for the thorough review of documents created within or outside of the company to ensurequality of standards meet or exceed client expectations.
ssential Functions and Other Job Information.
ssential FunctionsCoordinates and manages client electronic submission deliverables supportingregulatory compliance.
ssists in preparing electronic document outputs that meet requirements forregulatory publishing to include documents that work with sponsor and/orregulatory agency software programs meeting consistency and security issues.
nsures that all final electronic deliverables meet current regulatory electronicdocument requirements and guidance under general supervision of the Manager,Regulatory Publishing and assistance as appropriate from a Senior RegulatoryPublishing Specialist.
ssists with developing and implementing project-specific processes for sponsorswith unique technology requirements and may act as the company's liaison forelectronic submissions with the sponsor.
xercises judgment within defined procedures and practices to determineappropriate action.
valuates the publishing needs in relationship to the overall project timelines,quality and delivery.
ngages other project team members, functional units or publishingmanagement as necessary to deliver final product and resolve/mitigate identifiedissues or barriers to delivery.
cts independently within a project team to evaluate and deliver publishingtasks.
ob Complexity Works on problems of moderate scope where analysis of situations or data requiresa review of a variety of factors.
ob Knowledge Developing professional expertise, applies company policies and procedures toresolve a variety of issues.
upervision ReceivedNormally receives general instructions on routine work, detailed instructions on newprojects or assignments.
Exercises judgment within defined procedures andpractices to determine appropriate action.
usiness RelationshipsContacts are primarily internal to the company with infrequent external customer /vendor contact on routine matters.
Builds productive internal / external workingrelationships.
ualifications.
ducation and Experience.
achelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to2+ 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.
orking knowledge of regulatory requirements and guidances for document management andelectronic submissionsStrong knowledge of Microsoft (MS) Word, MS Excel, Adobe Acrobat, electronic documentmanagement systems, document publishing tools, publishing systems, eCTD validation and viewingtoolsStrong knowledge of electronic templates and skilled in formatting and troubleshooting templatesAbility to manage several complex projects in parallel and adapt to changing prioritiesAbility to exercise independent judgment in developing methods, techniques and evaluation of criteriausing defined procedures and practicesAbility to independently assess sponsor needs and work with project team members in producingcompliant deliverablesAbility to independently learn new technologiesStrong organizational skills and effective interpersonal skillsStrong analytical ability and problem-solving capabilitiesGood working knowledge of medical terminology, statistical concepts, and guidelines andrequirements of the FDA and other international regulatory agenciesStrong editorial/proofreading skillsDetail-oriented, thorough, and methodicalAbility to create and follow timelines and conduct long-range planningAbility to multitask performing numerous single or complex tasks without ignoring overall objectivesAbility to judge when to initiate changes and make final determinations in the presentation of data inaccordance with regulatory guidelines and reviewers' commentsAbility to concentrate on the detail in a document without losing sight of the document as a wholeManagement Role.
o management responsibilityWorking Conditions and Environment.
ork is performed in an office/ laboratory and/or a clinical environment.
xposure to biological fluids with potential exposure to infectious organisms.
xposure to electrical office equipment.
ersonal protective equipment required such as protective eyewear, garments and gloves.
hysical Requirements.
bility to work in an upright and /or stationary position for 6-8 hours per day.
epetitive hand movement of both hands with the ability to make fast, simple, repeated movementsof the fingers, hands, and wrists.
requent mobility required.
ccasional crouching, stooping, with frequent bending and twisting of upper body and neck.
ight to moderate lifting and carrying (or otherwise moves) objects including luggage and laptopcomputer with a maximum lift of lbs.
bility to access and use a variety of computer software developed both in-house and off-the-shelf.
bility to communicate information and ideas so others will understand; with the ability to listen toand understand information and ideas presented through spoken words and sentences.
requently interacts with others to obtain or relate information to diverse groups.
erforms a wide range of variable tasks as dictated by variable demands and changing conditionswith little predictability as to the occurrence.
Ability to perform under stress.
Ability to multi-task.
egular and consistent attendance.