29 Pharmaceutical Writer jobs in India

Our client , a globally recognized pharmaceutical leader, is seeking a highly experienced Senior Medical Writer to join their dynamic, fully remote research and development team. This critical role involves crafting clear, accurate, and compliant regulatory documents, clinical study reports, and scientific publications. You will be instrumental in communicating complex scientific data effectively to regulatory agencies, healthcare professionals, and other key stakeholders worldwide. The ideal candidate possesses a strong scientific background, exceptional writing skills, and a thorough understanding of pharmaceutical drug development processes and regulatory guidelines.

Responsibilities:

• Author, edit, and finalize a variety of regulatory documents, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and responses to regulatory authorities.
• Prepare clinical study protocols, Investigator's Brochures (IBs), Clinical Study Reports (CSRs), and other clinical development documents.
• Contribute to the development of manuscripts for publication in peer-reviewed journals and abstracts for scientific conferences.
• Ensure all medical writing outputs are scientifically accurate, medically sound, and adhere to applicable regulatory guidelines (e.g., ICH, FDA, EMA).
• Collaborate effectively with cross-functional teams, including clinical operations, biostatistics, regulatory affairs, and research scientists.
• Manage multiple writing projects simultaneously, ensuring timely completion and adherence to project timelines.
• Review and provide scientific and editorial input on documents authored by others.
• Stay current with therapeutic area advancements, regulatory intelligence, and medical writing best practices.
• Participate in relevant team meetings and contribute to strategic planning related to documentation.
• Ensure consistency in terminology and style across all company documents.

Qualifications:

• Master's or Ph.D. in a life science discipline (e.g., Pharmacology, Biology, Chemistry, Medicine) or equivalent experience.
• Minimum of 5-7 years of experience in medical writing within the pharmaceutical or biotechnology industry.
• Demonstrated expertise in preparing a range of regulatory submission documents.
• In-depth knowledge of drug development processes and relevant regulatory guidelines.
• Exceptional writing, editing, and proofreading skills with a strong command of scientific terminology.
• Ability to interpret complex scientific and clinical data and present it clearly and concisely.
• Excellent organizational and project management skills, with the ability to manage competing priorities in a remote setting.
• Strong interpersonal and communication skills for effective collaboration with diverse teams.
• Proficiency in Microsoft Office Suite and familiarity with document management systems.
• Proven ability to work independently and meet stringent deadlines.

This remote opportunity offers the chance to make a significant impact on global health by contributing to the development of life-changing therapies.

**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.

**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.

**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.

**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.

**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.

**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.

**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.