Premium Employer

i

This company page is being actively managed by Amgen Team. If you also belong to the team, you can get access from here

Amgen Verified Tick

Compare button icon Compare button icon Compare
5.0

based on 6 Reviews

filter salaries All Filters

450 Amgen Jobs

Clinical Trials Disclosure Manager

4-6 years

Hyderabad / Secunderabad

1 vacancy

Clinical Trials Disclosure Manager

Amgen

posted 16d ago

Job Description


  
 

What you will do 
Let’s do this. Let’s change the world. In this vital role, you will lead the preparation of clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with applicable regulations, guidances, and company requirements.

  • Work closely with the transparency team and crossfunctional stakeholders to define redaction strategy, implement redactions, lead crossfunctional review and approval, ensure submission readiness, and hand off for timely submission or posting

  • Support trend analysis and continuous improvement initiatives

  • Manage projects, coordinate the work of other staff, and prioritize work in order to meet internal and external deadlines

  •   
     

    What we expect of you 

  • Master’s degree and 4 to 6 years of pharmaceutical industry experience OR

  • Bachelor’s degree and 6 to 8 years of pharmaceutical industry experience OR

  • Diploma and 10 to 12 years of pharmaceutical industry experience

  • Minimum of 2 years experience in preparation of regulatory documents for public disclosure

  • Familiarity with international regulations, guidances and best practices on clinical transparency & disclosure, including protection of personal information and commercially confidential information





  • Basic Qualifications:

  • Experience understanding and interpreting data/information and its practical application

  • Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through

  • Good communication skills including excellent spoken and written English

  • Ability to follow controlled processes

  • Leadership skills, including ability to teach, negotiate and influence

  • Project management skills, including ability to prioritize work in order to meet required deadlines

  • Problem solving ability



  • 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.

    Employment Type: Full Time, Permanent

    Read full job description

    Prepare for Manager roles with real interview advice

    What people at Amgen are saying

    Manager salary at Amgen

    reported by 2 employees with 8-10 years exp.
    ₹27.4 L/yr - ₹35 L/yr
    95% more than the average Manager Salary in India
    View more details

    What Amgen employees are saying about work life

    based on 6 employees
    80%
    75%
    50%
    100%
    Flexible timing
    Monday to Friday
    No travel
    Day Shift
    View more insights

    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
    Health Insurance
    International Relocation
    Child care
    Gymnasium
    Cafeteria
    Work From Home +6 more
    View more benefits

    Compare Amgen with

    Biocon Limited

    3.9
    Compare

    DRJ & CO

    5.0
    Compare

    Sun Pharmaceutical Industries

    4.0
    Compare

    Cipla

    4.1
    Compare

    Glenmark Pharmaceuticals

    3.9
    Compare

    Torrent Pharmaceuticals

    3.9
    Compare

    Zydus Lifesciences

    4.1
    Compare

    Lupin

    4.2
    Compare

    Aurobindo Pharma

    4.0
    Compare

    DIVI'S Laboratories

    3.8
    Compare

    Avantor

    3.7
    Compare

    dsm-firmenich

    4.1
    Compare

    Kemin Industries

    4.4
    Compare

    Biomerieux

    3.8
    Compare

    Flagship Biotech International

    3.3
    Compare

    Zenotech Laboratories

    3.6
    Compare

    PREMAS Biotech

    3.3
    Compare

    Datar Genetics

    3.1
    Compare

    Sisco Research Laboratories

    3.9
    Compare

    BiOZEEN

    3.0
    Compare

    Similar Jobs for you

    Senior Associate at Amgen Inc.

    Hyderabad / Secunderabad

    3-5 Yrs

    ₹ 5-7 LPA

    Senior Associate at Amgen Inc.

    Hyderabad / Secunderabad

    3-5 Yrs

    ₹ 5-7 LPA

    Clinical Trial Assistant at Life Force Homeopathy

    Chennai, Pune + 5

    2-4 Yrs

    ₹ 4-6 LPA

    Quality Control Specialist at Excelya

    Kolkata, Mumbai + 5

    1-5 Yrs

    ₹ 3-7 LPA

    Service Specialist at Accenture Solutions Pvt Ltd

    Bangalore / Bengaluru

    7-11 Yrs

    ₹ 9-13 LPA

    Research Professional at Patanjali Research Foundation

    Haridwar, New Delhi

    1-4 Yrs

    ₹ 2-6 LPA

    Principal Investigator at QPS Bioserve

    Hyderabad / Secunderabad

    3-7 Yrs

    ₹ 7-10 LPA

    Clinical Head at RADIANT DENTAL CARE

    Chennai

    5-7 Yrs

    ₹ 8-10 LPA

    Senior Associate at Amgen Inc.

    Hyderabad / Secunderabad

    1-4 Yrs

    ₹ 2-5 LPA

    Senior Associate at Amgen Inc.

    Hyderabad / Secunderabad

    2-7 Yrs

    ₹ 3-7 LPA

    Clinical Trials Disclosure Manager

    4-6 Yrs

    Hyderabad / Secunderabad

    16d ago·via naukri.com

    Sr. Associate Regulatory Affairs

    2-5 Yrs

    Hyderabad / Secunderabad

    23hr ago·via naukri.com

    Principal CMC Statistician

    10-14 Yrs

    Hyderabad / Secunderabad

    2d ago·via naukri.com

    Sr. Associate Regulatory Affairs

    1-6 Yrs

    Hyderabad / Secunderabad

    2d ago·via naukri.com

    Onboarding Specialist

    0-5 Yrs

    Hyderabad / Secunderabad

    2d ago·via naukri.com

    Sr. Associate Regulatory Affairs

    1-2 Yrs

    Hyderabad / Secunderabad

    2d ago·via naukri.com

    Sr. Associate Regulatory Affairs

    2-5 Yrs

    Hyderabad / Secunderabad

    2d ago·via naukri.com

    Sr. Associate Regulatory Affairs

    1-6 Yrs

    Hyderabad / Secunderabad

    2d ago·via naukri.com

    Tax Senior Manager

    2-7 Yrs

    Hyderabad / Secunderabad

    2d ago·via naukri.com

    Senior Associate Regulatory Affairs

    1-6 Yrs

    Hyderabad / Secunderabad

    2d ago·via naukri.com
    write
    Share an Interview