131 Regulatory Writing jobs in India
Associate Regulatory Writing
Hyderabad, Andhra Pradesh
Amgen
Posted 2 days ago
Job Viewed
Job Description
**ABOUT AMGEN**
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**Roles & Responsibilities:**
+ Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team
+ Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting
+ Collaborate with team members to resolve problems and escalate issues
+ Record and maintain written redaction strategy for the study and product
+ Manage timelines and coordinate work across team
+ Execute clinical trial disclosure business process and ensure deliverables and delivery timelines in compliance with regulations, Amgen policy and SOPs and guidance documents
+ Tactical point of contact for assigned areas of responsibility, completes assigned action items, and maintains documentation of assigned responsibilities
+ Assist/support trial disclosure audits and inspections
+ Serve as Process Administer for CTRS, support active CTRS users, system access, inquiries, and issue resolution
+ Generate /manage reports, trackers, portals and metric activities
**Required Skills:**
+ Experience understanding and interpreting data/information and its practical application
+ Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
+ Ability to follow controlled processes
+ Excellent spoken and written English
+ Project management skills, including ability to prioritize work in order to meet required deadlines
+ Problem solving ability
**Basic Qualifications:**
+ Bachelor's degree
+ Minimum of 1 year experience working with regulatory documents in a biotech/ pharmaceutical environment
+ Familiarity with clinical research and clinical regulatory documents
+ Knowledge of clinical trial disclosure regulations, guidelines, and best practices
**Preferred Qualifications:**
+ > One year experience preparing regulatory documents for public disclosure
+ Familiarity with Clinical Trial Registry System, NIH Protocol Registration System (PRS), ClinicalTrials.gov, EudraCT, EU CTIS, and other registries
+ Familiarity with redaction/anonymization of clinical trial documents
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**Roles & Responsibilities:**
+ Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team
+ Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting
+ Collaborate with team members to resolve problems and escalate issues
+ Record and maintain written redaction strategy for the study and product
+ Manage timelines and coordinate work across team
+ Execute clinical trial disclosure business process and ensure deliverables and delivery timelines in compliance with regulations, Amgen policy and SOPs and guidance documents
+ Tactical point of contact for assigned areas of responsibility, completes assigned action items, and maintains documentation of assigned responsibilities
+ Assist/support trial disclosure audits and inspections
+ Serve as Process Administer for CTRS, support active CTRS users, system access, inquiries, and issue resolution
+ Generate /manage reports, trackers, portals and metric activities
**Required Skills:**
+ Experience understanding and interpreting data/information and its practical application
+ Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
+ Ability to follow controlled processes
+ Excellent spoken and written English
+ Project management skills, including ability to prioritize work in order to meet required deadlines
+ Problem solving ability
**Basic Qualifications:**
+ Bachelor's degree
+ Minimum of 1 year experience working with regulatory documents in a biotech/ pharmaceutical environment
+ Familiarity with clinical research and clinical regulatory documents
+ Knowledge of clinical trial disclosure regulations, guidelines, and best practices
**Preferred Qualifications:**
+ > One year experience preparing regulatory documents for public disclosure
+ Familiarity with Clinical Trial Registry System, NIH Protocol Registration System (PRS), ClinicalTrials.gov, EudraCT, EU CTIS, and other registries
+ Familiarity with redaction/anonymization of clinical trial documents
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
This advertiser has chosen not to accept applicants from your region.
0
Associate Regulatory Writing
Hyderabad, Andhra Pradesh
Amgen
Posted 2 days ago
Job Viewed
Job Description
**ABOUT AMGEN**
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**Roles & Responsibilities:**
+ Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team
+ Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting
+ Collaborate with team members to resolve problems and escalate issues
+ Record and maintain written redaction strategy for the study and product
+ Manage timelines and coordinate work across team
+ Execute clinical trial disclosure business process and ensure deliverables and delivery timelines in compliance with regulations, Amgen policy and SOPs and guidance documents
+ Tactical point of contact for assigned areas of responsibility, completes assigned action items, and maintains documentation of assigned responsibilities
+ Assist/support trial disclosure audits and inspections
+ Serve as Process Administer for CTRS, support active CTRS users, system access, inquiries, and issue resolution
+ Generate /manage reports, trackers, portals and metric activities
**Required Skills:**
+ Experience understanding and interpreting data/information and its practical application
+ Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
+ Ability to follow controlled processes
+ Excellent spoken and written English
+ Project management skills, including ability to prioritize work in order to meet required deadlines
+ Problem solving ability
**Basic Qualifications:**
+ Bachelor's degree
+ Minimum of 1 year experience working with regulatory documents in a biotech/ pharmaceutical environment
+ Familiarity with clinical research and clinical regulatory documents
+ Knowledge of clinical trial disclosure regulations, guidelines, and best practices
**Preferred Qualifications:**
+ > One year experience preparing regulatory documents for public disclosure
+ Familiarity with Clinical Trial Registry System, NIH Protocol Registration System (PRS), ClinicalTrials.gov, EudraCT, EU CTIS, and other registries
+ Familiarity with redaction/anonymization of clinical trial documents
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**Roles & Responsibilities:**
+ Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team
+ Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting
+ Collaborate with team members to resolve problems and escalate issues
+ Record and maintain written redaction strategy for the study and product
+ Manage timelines and coordinate work across team
+ Execute clinical trial disclosure business process and ensure deliverables and delivery timelines in compliance with regulations, Amgen policy and SOPs and guidance documents
+ Tactical point of contact for assigned areas of responsibility, completes assigned action items, and maintains documentation of assigned responsibilities
+ Assist/support trial disclosure audits and inspections
+ Serve as Process Administer for CTRS, support active CTRS users, system access, inquiries, and issue resolution
+ Generate /manage reports, trackers, portals and metric activities
**Required Skills:**
+ Experience understanding and interpreting data/information and its practical application
+ Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
+ Ability to follow controlled processes
+ Excellent spoken and written English
+ Project management skills, including ability to prioritize work in order to meet required deadlines
+ Problem solving ability
**Basic Qualifications:**
+ Bachelor's degree
+ Minimum of 1 year experience working with regulatory documents in a biotech/ pharmaceutical environment
+ Familiarity with clinical research and clinical regulatory documents
+ Knowledge of clinical trial disclosure regulations, guidelines, and best practices
**Preferred Qualifications:**
+ > One year experience preparing regulatory documents for public disclosure
+ Familiarity with Clinical Trial Registry System, NIH Protocol Registration System (PRS), ClinicalTrials.gov, EudraCT, EU CTIS, and other registries
+ Familiarity with redaction/anonymization of clinical trial documents
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
This advertiser has chosen not to accept applicants from your region.
1
Associate Regulatory Writing
Hyderabad, Andhra Pradesh
Amgen
Posted 2 days ago
Job Viewed
Job Description
**ABOUT AMGEN**
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**Roles & Responsibilities:**
+ Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team
+ Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting
+ Collaborate with team members to resolve problems and escalate issues
+ Record and maintain written redaction strategy for the study and product
+ Manage timelines and coordinate work across team
+ Execute clinical trial disclosure business process and ensure deliverables and delivery timelines in compliance with regulations, Amgen policy and SOPs and guidance documents
+ Tactical point of contact for assigned areas of responsibility, completes assigned action items, and maintains documentation of assigned responsibilities
+ Assist/support trial disclosure audits and inspections
+ Serve as Process Administer for CTRS, support active CTRS users, system access, inquiries, and issue resolution
+ Generate /manage reports, trackers, portals and metric activities
**Required Skills:**
+ Experience understanding and interpreting data/information and its practical application
+ Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
+ Ability to follow controlled processes
+ Excellent spoken and written English
+ Project management skills, including ability to prioritize work in order to meet required deadlines
+ Problem solving ability
**Basic Qualifications:**
+ Bachelor's degree
+ Minimum of 1 year experience working with regulatory documents in a biotech/ pharmaceutical environment
+ Familiarity with clinical research and clinical regulatory documents
+ Knowledge of clinical trial disclosure regulations, guidelines, and best practices
**Preferred Qualifications:**
+ > One year experience preparing regulatory documents for public disclosure
+ Familiarity with Clinical Trial Registry System, NIH Protocol Registration System (PRS), ClinicalTrials.gov, EudraCT, EU CTIS, and other registries
+ Familiarity with redaction/anonymization of clinical trial documents
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**Roles & Responsibilities:**
+ Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team
+ Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting
+ Collaborate with team members to resolve problems and escalate issues
+ Record and maintain written redaction strategy for the study and product
+ Manage timelines and coordinate work across team
+ Execute clinical trial disclosure business process and ensure deliverables and delivery timelines in compliance with regulations, Amgen policy and SOPs and guidance documents
+ Tactical point of contact for assigned areas of responsibility, completes assigned action items, and maintains documentation of assigned responsibilities
+ Assist/support trial disclosure audits and inspections
+ Serve as Process Administer for CTRS, support active CTRS users, system access, inquiries, and issue resolution
+ Generate /manage reports, trackers, portals and metric activities
**Required Skills:**
+ Experience understanding and interpreting data/information and its practical application
+ Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
+ Ability to follow controlled processes
+ Excellent spoken and written English
+ Project management skills, including ability to prioritize work in order to meet required deadlines
+ Problem solving ability
**Basic Qualifications:**
+ Bachelor's degree
+ Minimum of 1 year experience working with regulatory documents in a biotech/ pharmaceutical environment
+ Familiarity with clinical research and clinical regulatory documents
+ Knowledge of clinical trial disclosure regulations, guidelines, and best practices
**Preferred Qualifications:**
+ > One year experience preparing regulatory documents for public disclosure
+ Familiarity with Clinical Trial Registry System, NIH Protocol Registration System (PRS), ClinicalTrials.gov, EudraCT, EU CTIS, and other registries
+ Familiarity with redaction/anonymization of clinical trial documents
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
This advertiser has chosen not to accept applicants from your region.
2
Associate Regulatory Writing
Hyderabad, Andhra Pradesh
Amgen
Posted 2 days ago
Job Viewed
Job Description
**ABOUT AMGEN**
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**Roles & Responsibilities:**
+ Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team
+ Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting
+ Collaborate with team members to resolve problems and escalate issues
+ Record and maintain written redaction strategy for the study and product
+ Manage timelines and coordinate work across team
+ Execute clinical trial disclosure business process and ensure deliverables and delivery timelines in compliance with regulations, Amgen policy and SOPs and guidance documents
+ Tactical point of contact for assigned areas of responsibility, completes assigned action items, and maintains documentation of assigned responsibilities
+ Assist/support trial disclosure audits and inspections
+ Serve as Process Administer for CTRS, support active CTRS users, system access, inquiries, and issue resolution
+ Generate /manage reports, trackers, portals and metric activities
**Required Skills:**
+ Experience understanding and interpreting data/information and its practical application
+ Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
+ Ability to follow controlled processes
+ Excellent spoken and written English
+ Project management skills, including ability to prioritize work in order to meet required deadlines
+ Problem solving ability
**Basic Qualifications:**
+ Bachelor's degree
+ Minimum of 1 year experience working with regulatory documents in a biotech/ pharmaceutical environment
+ Familiarity with clinical research and clinical regulatory documents
+ Knowledge of clinical trial disclosure regulations, guidelines, and best practices
**Preferred Qualifications:**
+ > One year experience preparing regulatory documents for public disclosure
+ Familiarity with Clinical Trial Registry System, NIH Protocol Registration System (PRS), ClinicalTrials.gov, EudraCT, EU CTIS, and other registries
+ Familiarity with redaction/anonymization of clinical trial documents
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**Roles & Responsibilities:**
+ Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team
+ Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting
+ Collaborate with team members to resolve problems and escalate issues
+ Record and maintain written redaction strategy for the study and product
+ Manage timelines and coordinate work across team
+ Execute clinical trial disclosure business process and ensure deliverables and delivery timelines in compliance with regulations, Amgen policy and SOPs and guidance documents
+ Tactical point of contact for assigned areas of responsibility, completes assigned action items, and maintains documentation of assigned responsibilities
+ Assist/support trial disclosure audits and inspections
+ Serve as Process Administer for CTRS, support active CTRS users, system access, inquiries, and issue resolution
+ Generate /manage reports, trackers, portals and metric activities
**Required Skills:**
+ Experience understanding and interpreting data/information and its practical application
+ Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
+ Ability to follow controlled processes
+ Excellent spoken and written English
+ Project management skills, including ability to prioritize work in order to meet required deadlines
+ Problem solving ability
**Basic Qualifications:**
+ Bachelor's degree
+ Minimum of 1 year experience working with regulatory documents in a biotech/ pharmaceutical environment
+ Familiarity with clinical research and clinical regulatory documents
+ Knowledge of clinical trial disclosure regulations, guidelines, and best practices
**Preferred Qualifications:**
+ > One year experience preparing regulatory documents for public disclosure
+ Familiarity with Clinical Trial Registry System, NIH Protocol Registration System (PRS), ClinicalTrials.gov, EudraCT, EU CTIS, and other registries
+ Familiarity with redaction/anonymization of clinical trial documents
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
This advertiser has chosen not to accept applicants from your region.
3
Manager, Global Regulatory Writing
Hyderabad, Andhra Pradesh
Amgen
Posted 2 days ago
Job Viewed
Job Description
**Join Amgen's Mission of Serving Patients**
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**Global Regulatory Writing Manager**
**What you will do**
**Let's make an impact. Let's change the world. In this crucial role, you'll cultivate strong business relationships with key cross-functional team members. You may also take on the role of functional area lead on product teams, oversee writing activities for product submissions (with supervision), mentor and train junior writers, and support various departmental initiatives as needed.**
**Roles & Responsibilities:**
+ Prepare regulatory submission documents as assigned, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric Investigation Plans, and other regulatory documents
+ Perform the formal review and approval of authored documents, ensuring compliance with applicable standard operating procedures
+ With significant supervision, manage regulatory writing activities for product submissions, including new and supplemental drug applications and biologics license applications
+ Act as the functional area lead on product teams, such as the Global Regulatory Team, Evidence Generation Team, Global Safety Team, and Label Working Group.
+ May contribute functional area input to the Global Regulatory Plan and team objectives
+ May collaborate with contract and freelance writers.
+ May assist in training and mentoring junior medical writers.
+ May contribute to departmental and cross-departmental initiatives, as needed.
+ Develop document timelines with input from the team.
+ Stay up to date with relevant professional information and emerging technologies.
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The (vital attribute) professional we seek is a (type of person) with these qualifications.
**Basic Qualifications:**
+ 9-13 years of directly related experience
**Preferred Qualifications:**
**Functional Skills:**
+ Proficiency with word processing and other Microsoft Office Programs
+ Significant knowledge of scientific/technical writing and editing, and of overall clinical development process for new compounds
+ Ability to understand and follow complex standard operating procedures (SOP's), guidance documents, and work instructions
+ Understanding and application of principles, concepts, theories and standards of scientific/technical field
+ Substantial knowledge and understanding of International Council on Harmonization (ICH) and Good Clinical Practice (GCP) guidance's and requirements
**Soft Skills:**
+ Excellent written/oral communication skills and attention to detail
+ Ability to effectively demonstrate leadership in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment
+ Proficient time and project management skills.
+ Self-starter with a drive and perseverance to achieve results
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now**
**for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
**careers.amgen.com**
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**Global Regulatory Writing Manager**
**What you will do**
**Let's make an impact. Let's change the world. In this crucial role, you'll cultivate strong business relationships with key cross-functional team members. You may also take on the role of functional area lead on product teams, oversee writing activities for product submissions (with supervision), mentor and train junior writers, and support various departmental initiatives as needed.**
**Roles & Responsibilities:**
+ Prepare regulatory submission documents as assigned, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric Investigation Plans, and other regulatory documents
+ Perform the formal review and approval of authored documents, ensuring compliance with applicable standard operating procedures
+ With significant supervision, manage regulatory writing activities for product submissions, including new and supplemental drug applications and biologics license applications
+ Act as the functional area lead on product teams, such as the Global Regulatory Team, Evidence Generation Team, Global Safety Team, and Label Working Group.
+ May contribute functional area input to the Global Regulatory Plan and team objectives
+ May collaborate with contract and freelance writers.
+ May assist in training and mentoring junior medical writers.
+ May contribute to departmental and cross-departmental initiatives, as needed.
+ Develop document timelines with input from the team.
+ Stay up to date with relevant professional information and emerging technologies.
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The (vital attribute) professional we seek is a (type of person) with these qualifications.
**Basic Qualifications:**
+ 9-13 years of directly related experience
**Preferred Qualifications:**
**Functional Skills:**
+ Proficiency with word processing and other Microsoft Office Programs
+ Significant knowledge of scientific/technical writing and editing, and of overall clinical development process for new compounds
+ Ability to understand and follow complex standard operating procedures (SOP's), guidance documents, and work instructions
+ Understanding and application of principles, concepts, theories and standards of scientific/technical field
+ Substantial knowledge and understanding of International Council on Harmonization (ICH) and Good Clinical Practice (GCP) guidance's and requirements
**Soft Skills:**
+ Excellent written/oral communication skills and attention to detail
+ Ability to effectively demonstrate leadership in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment
+ Proficient time and project management skills.
+ Self-starter with a drive and perseverance to achieve results
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now**
**for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
**careers.amgen.com**
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
This advertiser has chosen not to accept applicants from your region.
4
Sr Associate Regulatory Writing
Hyderabad, Andhra Pradesh
Amgen
Posted 2 days ago
Job Viewed
Job Description
**ABOUT AMGEN**
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**Roles & Responsibilities:**
+ Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, or prepare documents for public registries e.g. ClinicalTrials.gov
+ Work closely with cross functional stakeholders to define redaction strategy and disclosure, lead review and approval, ensure submission readiness, and hand off for timely submission or posting
+ Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting
+ Communicate with team members or cross-functional stakeholders to resolve problems and escalate issues
+ Record and maintain written redaction strategy for the study and product
+ Support trend analysis and process improvement
+ Execute clinical trial disclosure business process and ensure
+ delivery in compliance with regulations, Amgen's policy and SOPs/ and guidance documents
+ Tactical point of contact for assigned areas of responsibility, completes assigned action items, and maintains documentation of assigned responsibilities
+ Assist/support trial disclosure audits and inspections
+ Serve as Process Administer for CTRS, support active CTRS users, system access, inquiries, and issue resolution
+ Generate /manage reports, trackers, portals and metric activities
**Required Skills:**
+ Experience understanding and interpreting data/information and its practical application
+ Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
+ Ability to follow controlled processes
+ Excellent spoken and written English
+ Ability to communicate and negotiate to influence stakeholders
+ Project management skills, including ability to prioritize work in order to meet required deadlines
+ Problem solving ability
**Basic Qualifications:**
+ Bachelor's degree
+ Minimum of 2 years experience in preparing regulatory documents for public disclosure
+ Understanding of clinical research and clinical regulatory documents
+ Working knowledge of clinical trial disclosure regulations, guidelines, and best practices
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**Roles & Responsibilities:**
+ Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, or prepare documents for public registries e.g. ClinicalTrials.gov
+ Work closely with cross functional stakeholders to define redaction strategy and disclosure, lead review and approval, ensure submission readiness, and hand off for timely submission or posting
+ Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting
+ Communicate with team members or cross-functional stakeholders to resolve problems and escalate issues
+ Record and maintain written redaction strategy for the study and product
+ Support trend analysis and process improvement
+ Execute clinical trial disclosure business process and ensure
+ delivery in compliance with regulations, Amgen's policy and SOPs/ and guidance documents
+ Tactical point of contact for assigned areas of responsibility, completes assigned action items, and maintains documentation of assigned responsibilities
+ Assist/support trial disclosure audits and inspections
+ Serve as Process Administer for CTRS, support active CTRS users, system access, inquiries, and issue resolution
+ Generate /manage reports, trackers, portals and metric activities
**Required Skills:**
+ Experience understanding and interpreting data/information and its practical application
+ Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
+ Ability to follow controlled processes
+ Excellent spoken and written English
+ Ability to communicate and negotiate to influence stakeholders
+ Project management skills, including ability to prioritize work in order to meet required deadlines
+ Problem solving ability
**Basic Qualifications:**
+ Bachelor's degree
+ Minimum of 2 years experience in preparing regulatory documents for public disclosure
+ Understanding of clinical research and clinical regulatory documents
+ Working knowledge of clinical trial disclosure regulations, guidelines, and best practices
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
This advertiser has chosen not to accept applicants from your region.
5
Sr Associate Regulatory Writing
Hyderabad, Andhra Pradesh
Amgen
Posted 2 days ago
Job Viewed
Job Description
**ABOUT AMGEN**
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**Roles & Responsibilities:**
+ Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, or prepare documents for public registries e.g. ClinicalTrials.gov
+ Work closely with cross functional stakeholders to define redaction strategy and disclosure, lead review and approval, ensure submission readiness, and hand off for timely submission or posting
+ Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting
+ Communicate with team members or cross-functional stakeholders to resolve problems and escalate issues
+ Record and maintain written redaction strategy for the study and product
+ Support trend analysis and process improvement
+ Execute clinical trial disclosure business process and ensure
+ delivery in compliance with regulations, Amgen's policy and SOPs/ and guidance documents
+ Tactical point of contact for assigned areas of responsibility, completes assigned action items, and maintains documentation of assigned responsibilities
+ Assist/support trial disclosure audits and inspections
+ Serve as Process Administer for CTRS, support active CTRS users, system access, inquiries, and issue resolution
+ Generate /manage reports, trackers, portals and metric activities
**Required Skills:**
+ Experience understanding and interpreting data/information and its practical application
+ Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
+ Ability to follow controlled processes
+ Excellent spoken and written English
+ Ability to communicate and negotiate to influence stakeholders
+ Project management skills, including ability to prioritize work in order to meet required deadlines
+ Problem solving ability
**Basic Qualifications:**
+ Bachelor's degree
+ Minimum of 2 years experience in preparing regulatory documents for public disclosure
+ Understanding of clinical research and clinical regulatory documents
+ Working knowledge of clinical trial disclosure regulations, guidelines, and best practices
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**Roles & Responsibilities:**
+ Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, or prepare documents for public registries e.g. ClinicalTrials.gov
+ Work closely with cross functional stakeholders to define redaction strategy and disclosure, lead review and approval, ensure submission readiness, and hand off for timely submission or posting
+ Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting
+ Communicate with team members or cross-functional stakeholders to resolve problems and escalate issues
+ Record and maintain written redaction strategy for the study and product
+ Support trend analysis and process improvement
+ Execute clinical trial disclosure business process and ensure
+ delivery in compliance with regulations, Amgen's policy and SOPs/ and guidance documents
+ Tactical point of contact for assigned areas of responsibility, completes assigned action items, and maintains documentation of assigned responsibilities
+ Assist/support trial disclosure audits and inspections
+ Serve as Process Administer for CTRS, support active CTRS users, system access, inquiries, and issue resolution
+ Generate /manage reports, trackers, portals and metric activities
**Required Skills:**
+ Experience understanding and interpreting data/information and its practical application
+ Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
+ Ability to follow controlled processes
+ Excellent spoken and written English
+ Ability to communicate and negotiate to influence stakeholders
+ Project management skills, including ability to prioritize work in order to meet required deadlines
+ Problem solving ability
**Basic Qualifications:**
+ Bachelor's degree
+ Minimum of 2 years experience in preparing regulatory documents for public disclosure
+ Understanding of clinical research and clinical regulatory documents
+ Working knowledge of clinical trial disclosure regulations, guidelines, and best practices
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
This advertiser has chosen not to accept applicants from your region.
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6
Scientific Writing Intern
Bengaluru, Karnataka
BioTecNika
Posted 5 days ago
Job Viewed
Job Description
Key Responsibilities:
● Content Research & Curation: Identify, verify, and prepare relevant biotech/life science opportunities, updates, and resources for our audience.
● Article Writing: Create engaging career guidance articles tailored to students and professionals.
● News & Research Summaries: Curate and simplify the latest developments in biotechnology, life sciences, and allied fields.
● Creative & Media Support: Assist in designing presentations, brochures, posters, infographics, and social media creatives.
● Engagement & Outreach: Ensure all content is clear, accurate, and engaging to connect effectively with readers.
Digital Skills and Tools Utilization:
● Social Media Engagement: Utilize LinkedIn, Instagram, Facebook, and YouTube to increase visibility and engage relevant audiences.
● Email Marketing and Web Presence: Implement email marketing strategies and maintain an active website.
● Data Mining and Analysis: Employ analytical tools to gather information on target audiences, including email addresses and LinkedIn profiles, and trade show participation.
Educational Requirements:
● Bachelor’s or Master’s degree in life sciences, biotechnology, Chemistry, pharma or a related field.
● Proven passion and ability for writing and must be a voracious reader.
● Strong research skills and attention to detail.
● Knowledge of scientific writing and digital content creation.
● Familiarity with social media platforms and digital marketing concepts.
● Ability to work independently and in a team.
● Enthusiasm for learning about industry trends.
Benefits:
● Work with an international life sciences company and leading life sciences and
biotechnology news portal Biotecnika.
● Gain experience in scientific writing, journalism, and digital marketing.
● Exposure to the latest trends and developments in life sciences and
biotechnology.
● Networking opportunities with professionals and researchers.
● Certificate of completion at the end of the internship.
Duration: The internship will be for a period of six months, with the possibility of an
extension based on performance.
This advertiser has chosen not to accept applicants from your region.
7
Experienced Scientific Writing Author
Fengkai Group Co., Limited
Posted 5 days ago
Job Viewed
Job Description
Responsibilities
- Taking ownership and responsibility for development (write, review, proofread, and data-check) of high-quality, client-ready scientific, medical, and educational materials like slides, abstracts, posters, manuscripts, MSL/training slide decks, infographics, congress and meetings materials, literature searches and reviews, standard response letters/medical information letters, and HCP engagement content according to client and audience needs with excellent attention to detail.
- Actively involved in reviewing materials developed by scientific writers to ensure strategic alignment and scientific accuracy as needed and providing clear constructive feedback, support, and supervision to writers. Mentor and train scientific writers by sharing best practices and client preferences, thereby contributing to skill development within the team.
- Having excellent knowledge of product/account to enable meaningful interactions with clients and authors, including consultancy where necessary. Liaising and building and maintaining strong and long-standing professional relationships with international pharmaceutical clients, healthcare professionals, internal and external stakeholders including authors, reviewers and key opinion leaders across therapeutic areas -- learning to anticipate their needs. This includes educating and advising clients on how to best implement their strategic and tactical plans and proactively provide recommendations to clients on how to improve scientific content and propose new document types/ways to disseminate client date more effectively.
- Effectively and proactively communicate with team members, authors/faculty, clients and vendors.
- Attend workshops/seminars/trainings to hone your skills and contribute to organizational objectives.
- Attending client and other external meetings and supporting senior team members as needed
- Apply your scientific and creative knowledge and work closely with client directors in developing ideas and executing effective medical communications initiatives in the digital space, including publication extenders, creation of infographics, interactive assets, website content, patient narratives, and medical information engagement plans. Also, Supporting with the development of visual content and materials using effective data visualization techniques and approaches. Contributing to innovative “out of the box” solutions for medical writing projects.
- You will be responsible for ensuring all materials follow/comply with client requirements/SOPs, style guides, client templates, client preferences (as applicable), and FengKai internal SOPs. Any updates to either of these items should be made consistently and documents should remain up to date.
- Perform as a document specialist, provide intellectual input across document types, and contribute to making cutting-edge research accessible to specific audiences as appropriate, by maintaining current awareness of developments across therapeutic areas or disciplines.
- Supporting with pitches, both during the preparation phase and the actual pitch.
Qualifications and Prerequisites
- Minimum of 3 years of experience in relevant fields of scientific writing.
- Possess a Ph.D. in Pharmacology, M.D., Ph.D. in Life Sciences, Pharm.D., or Ed.D.
- Clear, concise, scientific style of writing, with a high level of attention to detail and excellent language skills.
- Ability to adapt writing style to different materials and target audiences.
- Basic knowledge of biostatistics.
- Literature reviewing and evaluation capabilities.
- Very good working knowledge of MS Office.
This advertiser has chosen not to accept applicants from your region.
8
Experienced Scientific Writing Author
Fengkai Group Co., Limited
Posted 5 days ago
Job Viewed
Job Description
Responsibilities
- Taking ownership and responsibility for development (write, review, proofread, and data-check) of high-quality, client-ready scientific, medical, and educational materials like slides, abstracts, posters, manuscripts, MSL/training slide decks, infographics, congress and meetings materials, literature searches and reviews, standard response letters/medical information letters, and HCP engagement content according to client and audience needs with excellent attention to detail.
- Actively involved in reviewing materials developed by scientific writers to ensure strategic alignment and scientific accuracy as needed and providing clear constructive feedback, support, and supervision to writers. Mentor and train scientific writers by sharing best practices and client preferences, thereby contributing to skill development within the team.
- Having excellent knowledge of product/account to enable meaningful interactions with clients and authors, including consultancy where necessary. Liaising and building and maintaining strong and long-standing professional relationships with international pharmaceutical clients, healthcare professionals, internal and external stakeholders including authors, reviewers and key opinion leaders across therapeutic areas -- learning to anticipate their needs. This includes educating and advising clients on how to best implement their strategic and tactical plans and proactively provide recommendations to clients on how to improve scientific content and propose new document types/ways to disseminate client date more effectively.
- Effectively and proactively communicate with team members, authors/faculty, clients and vendors.
- Attend workshops/seminars/trainings to hone your skills and contribute to organizational objectives.
- Attending client and other external meetings and supporting senior team members as needed
- Apply your scientific and creative knowledge and work closely with client directors in developing ideas and executing effective medical communications initiatives in the digital space, including publication extenders, creation of infographics, interactive assets, website content, patient narratives, and medical information engagement plans. Also, Supporting with the development of visual content and materials using effective data visualization techniques and approaches. Contributing to innovative “out of the box” solutions for medical writing projects.
- You will be responsible for ensuring all materials follow/comply with client requirements/SOPs, style guides, client templates, client preferences (as applicable), and FengKai internal SOPs. Any updates to either of these items should be made consistently and documents should remain up to date.
- Perform as a document specialist, provide intellectual input across document types, and contribute to making cutting-edge research accessible to specific audiences as appropriate, by maintaining current awareness of developments across therapeutic areas or disciplines.
- Supporting with pitches, both during the preparation phase and the actual pitch.
Qualifications and Prerequisites
- Minimum of 3 years of experience in relevant fields of scientific writing.
- Possess a Ph.D. in Pharmacology, M.D., Ph.D. in Life Sciences, Pharm.D., or Ed.D.
- Clear, concise, scientific style of writing, with a high level of attention to detail and excellent language skills.
- Ability to adapt writing style to different materials and target audiences.
- Basic knowledge of biostatistics.
- Literature reviewing and evaluation capabilities.
- Very good working knowledge of MS Office.
This advertiser has chosen not to accept applicants from your region.
9