The publishing industry in India presents diverse opportunities for professionals skilled in content creation, editing, marketing, and sales. Job seekers can find roles in book publishing, academic publishing, digital media, and journalism. These positions often require strong communication skills, attention to detail, and a passion for literature and information dissemination.808 Publishing jobs in India
Manager - Publishing
Mumbai, Maharashtra
Abbott
Posted 5 days ago
Job Viewed
Job Description
**Job description:**
+ Lead a high preforming team of Submission publishers
+ Responsible for delivering and driving high quality submissions by self and the team in compliance with technical requirements from regulatory authorities.
+ Responsible for fixing/guiding the team to fix/resolve any errors/challenges/roadblocks to ensure quality output to the HA - Submissions troubleshooting
+ Drive first time right approach by educating the team and upstream workstreams on the relevant activities
+ Collaborate with other Operations team/other relevant stakeholders to work towards a common goal and drive and deliver quality outputs
+ Work closely with the team to Identify value adds/process improvements in the process and deploy the same for efficiency gain
+ Proactively work with the team to identify gaps/errors and liaise closely with the affiliates/Regional leads/any relevant key stakeholders to close the same through offering solutions
+ Work on work load versus resource mapping for an optimized resource management
+ Manage the Publishing workflow to acknowledge and deliver timely submissions to key stakeholders
+ Awareness, equip and adaptation of self and the team to all the change in regulations across the countries
+ Actively involved in testing and documentation of any new implementations or upgrades of the tools used in the organization
+ Train the team and also the end user through train trainer program on the systems for Publishing suite
+ Optimize the cost of tickets through screening for any end user related mistakes before raising the ticket
+ Be actively involed in tecnical discussions with ArisG for Publishing related queries to suggest or challenge on feature functionalties of Publishing suite
+ Conduct or actively contribute towards kick off meetings of eCTD implementation in a new country
+ Actively involved in career development planing and execution and competency development
+ Involved in hiring and onboarding any new talent
+ Performance evaluation of the team members
**Technical Competency and Development**
+ Work as an SME for the team and affiliates in regard to the relevant workstream processes
+ Deeper understanding of the of processes across product line - Pharma and Vaccines
+ Work towards competency enhancement of the team with constant touch base
+ Develop a backup for self to manage any technical queries, develop simplified work guide which will help use the same as reference material
+ An expert in e CTD concepts and trouble shooting
+ Exposure to markets - RoW (EM), EU, (US - would be good to have)
+ Exposure to varied Publsihing tools to idetnify white space and suggest optimization
**Minimum Experience/Training Required:**
A minimum of 10-12 years of experience in Submission publishing, Regulatory Affairs with atleast 5-6 years of people management and team handling experience.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
+ Lead a high preforming team of Submission publishers
+ Responsible for delivering and driving high quality submissions by self and the team in compliance with technical requirements from regulatory authorities.
+ Responsible for fixing/guiding the team to fix/resolve any errors/challenges/roadblocks to ensure quality output to the HA - Submissions troubleshooting
+ Drive first time right approach by educating the team and upstream workstreams on the relevant activities
+ Collaborate with other Operations team/other relevant stakeholders to work towards a common goal and drive and deliver quality outputs
+ Work closely with the team to Identify value adds/process improvements in the process and deploy the same for efficiency gain
+ Proactively work with the team to identify gaps/errors and liaise closely with the affiliates/Regional leads/any relevant key stakeholders to close the same through offering solutions
+ Work on work load versus resource mapping for an optimized resource management
+ Manage the Publishing workflow to acknowledge and deliver timely submissions to key stakeholders
+ Awareness, equip and adaptation of self and the team to all the change in regulations across the countries
+ Actively involved in testing and documentation of any new implementations or upgrades of the tools used in the organization
+ Train the team and also the end user through train trainer program on the systems for Publishing suite
+ Optimize the cost of tickets through screening for any end user related mistakes before raising the ticket
+ Be actively involed in tecnical discussions with ArisG for Publishing related queries to suggest or challenge on feature functionalties of Publishing suite
+ Conduct or actively contribute towards kick off meetings of eCTD implementation in a new country
+ Actively involved in career development planing and execution and competency development
+ Involved in hiring and onboarding any new talent
+ Performance evaluation of the team members
**Technical Competency and Development**
+ Work as an SME for the team and affiliates in regard to the relevant workstream processes
+ Deeper understanding of the of processes across product line - Pharma and Vaccines
+ Work towards competency enhancement of the team with constant touch base
+ Develop a backup for self to manage any technical queries, develop simplified work guide which will help use the same as reference material
+ An expert in e CTD concepts and trouble shooting
+ Exposure to markets - RoW (EM), EU, (US - would be good to have)
+ Exposure to varied Publsihing tools to idetnify white space and suggest optimization
**Minimum Experience/Training Required:**
A minimum of 10-12 years of experience in Submission publishing, Regulatory Affairs with atleast 5-6 years of people management and team handling experience.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
This advertiser has chosen not to accept applicants from your region.
0
Publishing Specialist
Bengaluru, Karnataka
Biocon Biologics
Posted 1 day ago
Job Viewed
Job Description
Key Responsibilities:
- Strong understanding of eCTD, NeeS, and ICH guidelines.
- Familiarity with Regulatory systems and Publishing tools.
- Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe Acrobat, MS Excel, SharePoint.
- Ability to perform end-to-end eCTD submission process, including Document level Publishing and Dossier compilation, and dispatch of submissions to respective Health Authorities (Developed and ROW Markets)
- Manage lifecycle submissions including variations, amendments, and renewals.
- Perform document-level publishing, hyperlinking, bookmarking, and validation.
- Conduct quality control checks to ensure submission readiness.
- Collaborate with cross-functional teams including Regulatory Affairs, CMC, and Clinical.
- Stay updated with global regulatory guidelines (ICH, FDA, EMA).
- Detail-oriented with a collaborative mindset.
- Minimum Qualifications and Experience
- B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc.
- Minimum 4 to 8 years
- Preferred Qualifications/ Skills
- Proficiency in managing Regulatory eCTD Submission for all Global Markets.
- Good knowledge on eCTD Guidance and understanding validation criteria requirement.
- Strong communication and interpersonal skills.
- Experience with electronic submission (New Development Product Filings / LCM).
- Strong project management skills, with the ability to manage multiple projects and deadlines simultaneously.
- High level of attention to detail and accuracy in document level publishing and submission compilation/validation.
- Ability to work collaboratively in a cross-functional team environment.
- Proficiency in using regulatory databases, information management systems, and other relevant software tools.
- Commitment to staying updated on regulatory changes and advancements in the field.
This advertiser has chosen not to accept applicants from your region.
1
Publishing Specialist
Bengaluru, Karnataka
Biocon Biologics
Posted today
Job Viewed
Job Description
Key Responsibilities:
- Strong understanding of eCTD, NeeS, and ICH guidelines.
- Familiarity with Regulatory systems and Publishing tools.
- Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe Acrobat, MS Excel, SharePoint.
- Ability to perform end-to-end eCTD submission process, including Document level Publishing and Dossier compilation, and dispatch of submissions to respective Health Authorities (Developed and ROW Markets)
- Manage lifecycle submissions including variations, amendments, and renewals.
- Perform document-level publishing, hyperlinking, bookmarking, and validation.
- Conduct quality control checks to ensure submission readiness.
- Collaborate with cross-functional teams including Regulatory Affairs, CMC, and Clinical.
- Stay updated with global regulatory guidelines (ICH, FDA, EMA).
- Detail-oriented with a collaborative mindset.
- Minimum Qualifications and Experience
- B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc.
- Minimum 4 to 8 years
- Preferred Qualifications/ Skills
- Proficiency in managing Regulatory eCTD Submission for all Global Markets.
- Good knowledge on eCTD Guidance and understanding validation criteria requirement.
- Strong communication and interpersonal skills.
- Experience with electronic submission (New Development Product Filings / LCM).
- Strong project management skills, with the ability to manage multiple projects and deadlines simultaneously.
- High level of attention to detail and accuracy in document level publishing and submission compilation/validation.
- Ability to work collaboratively in a cross-functional team environment.
- Proficiency in using regulatory databases, information management systems, and other relevant software tools.
- Commitment to staying updated on regulatory changes and advancements in the field.
- Strong understanding of eCTD, NeeS, and ICH guidelines.
- Familiarity with Regulatory systems and Publishing tools.
- Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe Acrobat, MS Excel, SharePoint.
- Ability to perform end-to-end eCTD submission process, including Document level Publishing and Dossier compilation, and dispatch of submissions to respective Health Authorities (Developed and ROW Markets)
- Manage lifecycle submissions including variations, amendments, and renewals.
- Perform document-level publishing, hyperlinking, bookmarking, and validation.
- Conduct quality control checks to ensure submission readiness.
- Collaborate with cross-functional teams including Regulatory Affairs, CMC, and Clinical.
- Stay updated with global regulatory guidelines (ICH, FDA, EMA).
- Detail-oriented with a collaborative mindset.
- Minimum Qualifications and Experience
- B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc.
- Minimum 4 to 8 years
- Preferred Qualifications/ Skills
- Proficiency in managing Regulatory eCTD Submission for all Global Markets.
- Good knowledge on eCTD Guidance and understanding validation criteria requirement.
- Strong communication and interpersonal skills.
- Experience with electronic submission (New Development Product Filings / LCM).
- Strong project management skills, with the ability to manage multiple projects and deadlines simultaneously.
- High level of attention to detail and accuracy in document level publishing and submission compilation/validation.
- Ability to work collaboratively in a cross-functional team environment.
- Proficiency in using regulatory databases, information management systems, and other relevant software tools.
- Commitment to staying updated on regulatory changes and advancements in the field.
This advertiser has chosen not to accept applicants from your region.
2
Publishing Specialist
Bengaluru, Karnataka
Biocon Biologics
Posted today
Job Viewed
Job Description
Key Responsibilities:
- Strong understanding of eCTD, NeeS, and ICH guidelines.
- Familiarity with Regulatory systems and Publishing tools.
- Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe Acrobat, MS Excel, SharePoint.
- Ability to perform end-to-end eCTD submission process, including Document level Publishing and Dossier compilation, and dispatch of submissions to respective Health Authorities (Developed and ROW Markets)
- Manage lifecycle submissions including variations, amendments, and renewals.
- Perform document-level publishing, hyperlinking, bookmarking, and validation.
- Conduct quality control checks to ensure submission readiness.
- Collaborate with cross-functional teams including Regulatory Affairs, CMC, and Clinical.
- Stay updated with global regulatory guidelines (ICH, FDA, EMA).
- Detail-oriented with a collaborative mindset.
- Minimum Qualifications and Experience
- B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc.
- Minimum 4 to 8 years
- Preferred Qualifications/ Skills
- Proficiency in managing Regulatory eCTD Submission for all Global Markets.
- Good knowledge on eCTD Guidance and understanding validation criteria requirement.
- Strong communication and interpersonal skills.
- Experience with electronic submission (New Development Product Filings / LCM).
- Strong project management skills, with the ability to manage multiple projects and deadlines simultaneously.
- High level of attention to detail and accuracy in document level publishing and submission compilation/validation.
- Ability to work collaboratively in a cross-functional team environment.
- Proficiency in using regulatory databases, information management systems, and other relevant software tools.
- Commitment to staying updated on regulatory changes and advancements in the field.
This advertiser has chosen not to accept applicants from your region.
3
Publishing Associate
Mumbai, Maharashtra
One Point Six Technologies Pvt Ltd
Posted today
Job Viewed
Job Description
The role is to help authors publish their books. Majority of the calls are outbound calls. The work includes understanding publishing goals of authors and helping them find the best way forward to get their work published.
Responsibilities:
1. Need to dial 100 calls per day
2. Need to connect 35 authors per day
3.Need to do 20 author profiling per day
Experience - 1-3yrs experience in outbound calls
Skills Required: 1. Excellent verbal and written communications in English
2.Self - driven, who can work with direction but little supervision
3.Ability to multitask priority and manages time effectively
This advertiser has chosen not to accept applicants from your region.
4
Manager - Publishing
Mumbai, Maharashtra
Abbott
Posted today
Job Viewed
Job Description
Job description:
Technical Competency and Development
Minimum Experience/Training Required:
A minimum of 8 - 10 years of experience in Submission publishing, Regulatory Affairs
This advertiser has chosen not to accept applicants from your region.
5
Publishing Specialist
Bangalore, Karnataka
Biocon Biologics
Posted 9 days ago
Job Viewed
Job Description
Key Responsibilities:
- Strong understanding of eCTD, NeeS, and ICH guidelines.
- Familiarity with Regulatory systems and Publishing tools.
- Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe Acrobat, MS Excel, SharePoint.
- Ability to perform end-to-end eCTD submission process, including Document level Publishing and Dossier compilation, and dispatch of submissions to respective Health Authorities (Developed and ROW Markets)
- Manage lifecycle submissions including variations, amendments, and renewals.
- Perform document-level publishing, hyperlinking, bookmarking, and validation.
- Conduct quality control checks to ensure submission readiness.
- Collaborate with cross-functional teams including Regulatory Affairs, CMC, and Clinical.
- Stay updated with global regulatory guidelines (ICH, FDA, EMA).
- Detail-oriented with a collaborative mindset.
- Minimum Qualifications and Experience
- B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc.
- Minimum 4 to 8 years
- Preferred Qualifications/ Skills
- Proficiency in managing Regulatory eCTD Submission for all Global Markets.
- Good knowledge on eCTD Guidance and understanding validation criteria requirement.
- Strong communication and interpersonal skills.
- Experience with electronic submission (New Development Product Filings / LCM).
- Strong project management skills, with the ability to manage multiple projects and deadlines simultaneously.
- High level of attention to detail and accuracy in document level publishing and submission compilation/validation.
- Ability to work collaboratively in a cross-functional team environment.
- Proficiency in using regulatory databases, information management systems, and other relevant software tools.
- Commitment to staying updated on regulatory changes and advancements in the field.
This advertiser has chosen not to accept applicants from your region.
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6
Publishing Specialist
Bengaluru, Karnataka
Biocon Biologics
Posted today
Job Viewed
Job Description
Key Responsibilities:
- Strong understanding of eCTD, NeeS, and ICH guidelines.
- Familiarity with Regulatory systems and Publishing tools.
- Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe Acrobat, MS Excel, SharePoint.
- Ability to perform end-to-end eCTD submission process, including Document level Publishing and Dossier compilation, and dispatch of submissions to respective Health Authorities (Developed and ROW Markets)
- Manage lifecycle submissions including variations, amendments, and renewals.
- Perform document-level publishing, hyperlinking, bookmarking, and validation.
- Conduct quality control checks to ensure submission readiness.
- Collaborate with cross-functional teams including Regulatory Affairs, CMC, and Clinical.
- Stay updated with global regulatory guidelines (ICH, FDA, EMA).
- Detail-oriented with a collaborative mindset.
- Minimum Qualifications and Experience
- B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc.
- Minimum 4 to 8 years
- Preferred Qualifications/ Skills
- Proficiency in managing Regulatory eCTD Submission for all Global Markets.
- Good knowledge on eCTD Guidance and understanding validation criteria requirement.
- Strong communication and interpersonal skills.
- Experience with electronic submission (New Development Product Filings / LCM).
- Strong project management skills, with the ability to manage multiple projects and deadlines simultaneously.
- High level of attention to detail and accuracy in document level publishing and submission compilation/validation.
- Ability to work collaboratively in a cross-functional team environment.
- Proficiency in using regulatory databases, information management systems, and other relevant software tools.
- Commitment to staying updated on regulatory changes and advancements in the field.
This advertiser has chosen not to accept applicants from your region.
7
Publishing Ethics Expert
Chennai, Tamil Nadu
RELX INC
Posted 3 days ago
Job Viewed
Job Description
Publishing Ethics Expert
Do you enjoy supporting Ethics investigations?
Do you have an interest in research integrity and publishing ethics?
Location: UK, China or NL
About our Team
STM Journals publishes more than 2,600 peer-reviewed journals. Elsevier is committed to nurturing and upholding research integrity within our journals and within the wider research community. The role of the Expert in Publishing Ethics is to support this commitment by advising on best practice in handling ethical allegations in all fields of research, conducting investigations when allegations of unethical misconduct is raised, providing input to initiatives which aim to prevent or detect ethical issues, and training internal and external stakeholders on the Committee on Publication Ethics (COPE) and Elsevier best practices and policies. The role involves support to editors, while always respecting and upholding the independence of editors' decision making.
About the Role
We are seeking a collaborative and analytical colleague, who is meticulous in their fact-checking and problem-solving, has a strong sense of natural justice and has excellent communication skills. Applicants will ideally have a qualification in a STM discipline and at least three years of relevant experience, either in publishing or related organisations (e.g. publisher or editor role), or research integrity within academic institutes.
Responsibilities
+ Assessment of activities by authors, reviewers, editors, guest editors and others
+ Supporting editors in assessing allegations including plagiarism, duplication, authorship disputes, peer review manipulation, and figure manipulation/duplication
+ Providing editors with comments on potential corrections, editor notes, expressions of concern and retraction notices
+ Liaison with legal and communications experts, as appropriate
+ Managing cases involving multiple journals and networks of stakeholders
+ Communicating precisely and diplomatically with all stakeholders.
+ Raising awareness and knowledge levels of ethical policies and procedures.
Requirements
+ A minimum of three years' relevant experience, direct publishing and editorial experience or Research Integrity experience is desirable
+ Degree in an academic discipline
+ Knowledge of peer-review and the publishing process, and ethical guidelines (e.g. COPE best practices)
+ Fluent English in both written and speaking
+ Excellent communications skills
+ Experience supporting editors or other senior academics
+ Ability to engage effectively with diverse stakeholders, academic societies, and professional organizations
Work in a way that works for you
We promote a healthy work/life balance across the organisation. We offer an appealing working prospect for our people. With numerous wellbeing initiatives, shared parental leave, study assistance and sabbaticals, we will help you meet your immediate responsibilities and your long-term goals.
+ Working flexible hours - flexing the times when you work in the day to help you fit everything in and work when you are the most productive
Working for you
We know that your wellbeing and happiness are key to a long and successful career. These are some of the benefits we are delighted to offer:
+ Generous holiday allowance with the option to buy additional days
+ Health screening, eye care vouchers and private medical benefits
+ Wellbeing programs
+ Life assurance
+ Access to a competitive contributory pension scheme
+ Save As You Earn share option scheme
+ Travel Season ticket loan
+ Electric Vehicle Scheme
+ Optional Dental Insurance
+ Maternity, paternity and shared parental leave
+ Employee Assistance Programme
+ Access to emergency care for both the elderly and children
+ RECARES days, giving you time to support the charities and causes that matter to you
+ Access to employee resource groups with dedicated time to volunteer
+ Access to extensive learning and development resources
+ Access to employee discounts scheme via Perks at Work
About the Business
A global leader in information and analytics, we help researchers and healthcare professionals advance science and improve health outcomes for the benefit of society. Building on our publishing heritage, we combine quality information and vast data sets with analytics to support visionary science and research, health education and interactive learning, as well as exceptional healthcare and clinical practice. At Elsevier, your work contributes to the world's grand challenges and a more sustainable future. We harness innovative technologies to support science and healthcare to partner for a better world.
---
We are committed to providing a fair and accessible hiring process. If you have a disability or other need that requires accommodation or adjustment, please let us know by completing our Applicant Request Support Form or please contact 1- .
Criminals may pose as recruiters asking for money or personal information. We never request money or banking details from job applicants. Learn more about spotting and avoiding scams here .
Please read our Candidate Privacy Policy .
We are an equal opportunity employer: qualified applicants are considered for and treated during employment without regard to race, color, creed, religion, sex, national origin, citizenship status, disability status, protected veteran status, age, marital status, sexual orientation, gender identity, genetic information, or any other characteristic protected by law.
USA Job Seekers:
EEO Know Your Rights .
RELX is a global provider of information-based analytics and decision tools for professional and business customers, enabling them to make better decisions, get better results and be more productive.
Our purpose is to benefit society by developing products that help researchers advance scientific knowledge; doctors and nurses improve the lives of patients; lawyers promote the rule of law and achieve justice and fair results for their clients; businesses and governments prevent fraud; consumers access financial services and get fair prices on insurance; and customers learn about markets and complete transactions.
Our purpose guides our actions beyond the products that we develop. It defines us as a company. Every day across RELX our employees are inspired to undertake initiatives that make unique contributions to society and the communities in which we operate.
Do you enjoy supporting Ethics investigations?
Do you have an interest in research integrity and publishing ethics?
Location: UK, China or NL
About our Team
STM Journals publishes more than 2,600 peer-reviewed journals. Elsevier is committed to nurturing and upholding research integrity within our journals and within the wider research community. The role of the Expert in Publishing Ethics is to support this commitment by advising on best practice in handling ethical allegations in all fields of research, conducting investigations when allegations of unethical misconduct is raised, providing input to initiatives which aim to prevent or detect ethical issues, and training internal and external stakeholders on the Committee on Publication Ethics (COPE) and Elsevier best practices and policies. The role involves support to editors, while always respecting and upholding the independence of editors' decision making.
About the Role
We are seeking a collaborative and analytical colleague, who is meticulous in their fact-checking and problem-solving, has a strong sense of natural justice and has excellent communication skills. Applicants will ideally have a qualification in a STM discipline and at least three years of relevant experience, either in publishing or related organisations (e.g. publisher or editor role), or research integrity within academic institutes.
Responsibilities
+ Assessment of activities by authors, reviewers, editors, guest editors and others
+ Supporting editors in assessing allegations including plagiarism, duplication, authorship disputes, peer review manipulation, and figure manipulation/duplication
+ Providing editors with comments on potential corrections, editor notes, expressions of concern and retraction notices
+ Liaison with legal and communications experts, as appropriate
+ Managing cases involving multiple journals and networks of stakeholders
+ Communicating precisely and diplomatically with all stakeholders.
+ Raising awareness and knowledge levels of ethical policies and procedures.
Requirements
+ A minimum of three years' relevant experience, direct publishing and editorial experience or Research Integrity experience is desirable
+ Degree in an academic discipline
+ Knowledge of peer-review and the publishing process, and ethical guidelines (e.g. COPE best practices)
+ Fluent English in both written and speaking
+ Excellent communications skills
+ Experience supporting editors or other senior academics
+ Ability to engage effectively with diverse stakeholders, academic societies, and professional organizations
Work in a way that works for you
We promote a healthy work/life balance across the organisation. We offer an appealing working prospect for our people. With numerous wellbeing initiatives, shared parental leave, study assistance and sabbaticals, we will help you meet your immediate responsibilities and your long-term goals.
+ Working flexible hours - flexing the times when you work in the day to help you fit everything in and work when you are the most productive
Working for you
We know that your wellbeing and happiness are key to a long and successful career. These are some of the benefits we are delighted to offer:
+ Generous holiday allowance with the option to buy additional days
+ Health screening, eye care vouchers and private medical benefits
+ Wellbeing programs
+ Life assurance
+ Access to a competitive contributory pension scheme
+ Save As You Earn share option scheme
+ Travel Season ticket loan
+ Electric Vehicle Scheme
+ Optional Dental Insurance
+ Maternity, paternity and shared parental leave
+ Employee Assistance Programme
+ Access to emergency care for both the elderly and children
+ RECARES days, giving you time to support the charities and causes that matter to you
+ Access to employee resource groups with dedicated time to volunteer
+ Access to extensive learning and development resources
+ Access to employee discounts scheme via Perks at Work
About the Business
A global leader in information and analytics, we help researchers and healthcare professionals advance science and improve health outcomes for the benefit of society. Building on our publishing heritage, we combine quality information and vast data sets with analytics to support visionary science and research, health education and interactive learning, as well as exceptional healthcare and clinical practice. At Elsevier, your work contributes to the world's grand challenges and a more sustainable future. We harness innovative technologies to support science and healthcare to partner for a better world.
---
We are committed to providing a fair and accessible hiring process. If you have a disability or other need that requires accommodation or adjustment, please let us know by completing our Applicant Request Support Form or please contact 1- .
Criminals may pose as recruiters asking for money or personal information. We never request money or banking details from job applicants. Learn more about spotting and avoiding scams here .
Please read our Candidate Privacy Policy .
We are an equal opportunity employer: qualified applicants are considered for and treated during employment without regard to race, color, creed, religion, sex, national origin, citizenship status, disability status, protected veteran status, age, marital status, sexual orientation, gender identity, genetic information, or any other characteristic protected by law.
USA Job Seekers:
EEO Know Your Rights .
RELX is a global provider of information-based analytics and decision tools for professional and business customers, enabling them to make better decisions, get better results and be more productive.
Our purpose is to benefit society by developing products that help researchers advance scientific knowledge; doctors and nurses improve the lives of patients; lawyers promote the rule of law and achieve justice and fair results for their clients; businesses and governments prevent fraud; consumers access financial services and get fair prices on insurance; and customers learn about markets and complete transactions.
Our purpose guides our actions beyond the products that we develop. It defines us as a company. Every day across RELX our employees are inspired to undertake initiatives that make unique contributions to society and the communities in which we operate.
This advertiser has chosen not to accept applicants from your region.
8
Regulatory Publishing Specialist
ThermoFisher Scientific
Posted 5 days ago
Job Viewed
Job Description
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
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.
Key responsibilities:
- 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.
Keys to Success:
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 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
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! 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.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1- *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
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.
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**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
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.
Key responsibilities:
- 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.
Keys to Success:
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 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
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! 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.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1- *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
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.
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