Opportunity for B. Pharma/ M. Pharma/ Pharma D/ Ph D/ B. Sc/ M. Sc as a Scientif
PHARMACY INDIA, May, MO, United States
Position Summary
To coordinate and author documents needed for regulatory submissions, ensuring the coordination and integration of the scientific, medical, and regulatory input from cross‑functional team members.
Key Responsibilities
Coordinate and author regulatory documents such as Investigator’s Brochures (IB), development safety update reports, periodic benefit‑risk evaluation reports, clinical study reports (CSR), protocols, and high‑level summary documents, ensuring coordination and integration of the scientific, medical, and regulatory input from dev team members.
Participate in relevant document subteams and ensure effective planning and management of timelines for all components of assigned documents.
Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.
Maintain document prototypes and shells.
Comply with internal and external processes and guidelines while managing the review process and resolve issues, errors, or inconsistencies with relevant team members to ensure timely completion and high quality of assigned documents.
Review and edit documents as required.
Skill & Knowledge
Demonstrated strong writing skills in authoring and managing the production of IB, Safety Aggregate Report, Clinical Protocols, and/or CSR.
Ability to analyze and interpret complex data from a broad range of scientific disciplines.
Understanding of global pharmaceutical drug development.
Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross‑functional team.
Working knowledge of a document management system and basic knowledge of the document publishing process.
Job Details
Position: Scientific Writer II
Qualifications: B.Pharm, M.Pharm, B.Sc., M.Sc., Pharma D, Ph.D.
Experience: 2–4 years
Salary: Competitive
Location: Hyderabad
Employment Type: Full Time, Regular
Apply Online: Available on Bristol Myers Squibb career portal
#J-18808-Ljbffr
To coordinate and author documents needed for regulatory submissions, ensuring the coordination and integration of the scientific, medical, and regulatory input from cross‑functional team members.
Key Responsibilities
Coordinate and author regulatory documents such as Investigator’s Brochures (IB), development safety update reports, periodic benefit‑risk evaluation reports, clinical study reports (CSR), protocols, and high‑level summary documents, ensuring coordination and integration of the scientific, medical, and regulatory input from dev team members.
Participate in relevant document subteams and ensure effective planning and management of timelines for all components of assigned documents.
Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.
Maintain document prototypes and shells.
Comply with internal and external processes and guidelines while managing the review process and resolve issues, errors, or inconsistencies with relevant team members to ensure timely completion and high quality of assigned documents.
Review and edit documents as required.
Skill & Knowledge
Demonstrated strong writing skills in authoring and managing the production of IB, Safety Aggregate Report, Clinical Protocols, and/or CSR.
Ability to analyze and interpret complex data from a broad range of scientific disciplines.
Understanding of global pharmaceutical drug development.
Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross‑functional team.
Working knowledge of a document management system and basic knowledge of the document publishing process.
Job Details
Position: Scientific Writer II
Qualifications: B.Pharm, M.Pharm, B.Sc., M.Sc., Pharma D, Ph.D.
Experience: 2–4 years
Salary: Competitive
Location: Hyderabad
Employment Type: Full Time, Regular
Apply Online: Available on Bristol Myers Squibb career portal
#J-18808-Ljbffr