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Sr Associate Regulatory Writing
Amgen
posted 14d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Sr. Associate, Regulatory Writing
Writes and edits non-complex regulatory documents ( eg , simple clinical study report, investigator brochure) and simple standalone documents ( eg , informed consent forms )
Participates in collaborative team activities for non-complex documents, including support to collect input from authors/reviewers
Participates in the cross-functional document review process, comment triage, meeting attendance, and incorporation of feedback for development of subsequent drafts or for finalization
Generates appropriate in-text tables and figures
Manages the development of regulatory documents, ensuring compliance with guidelines and timelines ; collaborate with Project T eams to track progress, facilitate reviews, and ensure documents meet regulatory standards for submission.
Learns and uses organizationally required authoring tools and technology platforms
Attends cross-functional meetings with other writers and departments, as appropriate , to share and gather information relevant for successful completion of their own and inter-dependent project s
Documents in scope include , but are not limited to:Clinical Study Reports, Observational Research Study Reports , Plain Language Summaries, I nvestigator B rochure s, local R isk M anagement P lan s , non-complex Original Protocols/ Protocol Amendments, and ICFs .
Understands and complies with SOPs, templates, best practices, policies, Regulatory Writing Style Guides
Basic Qualifications
Bachelor’s degree
Minimum of 2 years of experience in preparing regulatory documents
Familiarity with clinical research and clinical regulatory documents
Knowledge of clinical study regulations, guidelines, and best practices
Preferred Qualifications
Scientific or medical knowledge
Experience analyzing interpretating scientific data
Exposure to or working knowledge of basic statistical and medical communication principles
Demonstrated passion for writing (extra-curricular, scientific, etc.)
Strong oral and written communication skills, including ability to write scientific documents and summarize scientific data
Able to collaborate with others, and to build solid and positive relationships with cross-functional team members
Able to work independently and problem solve
Attention to detail and accuracy
Organizational skills in time and project management; ability to manage more than one project simultaneously
Working knowledge of typical office applications ( eg , Microsoft Office, SharePoint)
Employment Type: Full Time, Permanent
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What people at Amgen are saying
Senior Associate salary at Amgen
reported by
13
employees
with 4-12
years exp.
₹8.5
L/yr - ₹25
L/yr
75%
more
than the average Senior Associate Salary in India
View more details
What Amgen employees are saying about work life
based on 7 employees
Flexible timing
Monday to Friday
No travel
Night Shift
Amgen Benefits
Submitted by Company
Health Insurance Child care Education Assistance Employee volunteer program and company matching donation program Flexible work environment Competitive base pay and annual bonus opportunities
Submitted by Employees
View more benefits 
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