Senior Manager, Global Regulatory Writing

Amgen

  • Hyderabad, Telangana
  • Permanent
  • Full-time
  • 7 days ago
Career Category RegulatoryJob DescriptionAt 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 six therapeutic areas –Oncology, Inflammation, Obesity, General Medicine, Biosimilars, 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.Regulatory Writing Senior ManagerWhat you will doLet’s do this. Let’s change the world. In this vital role you will Prepare and oversee the preparation of regulatory submission documents that comply with global regulatory standards
  • Write or oversee the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phase 1 through 4)
  • Write CTD sections including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety documents, across therapeutic areas and for biosimilars
  • Write other regulatory submission documents (eg, RTQs, PIP, white papers, breakthrough therapy applications, orphan drug applications)
  • Manage study timelines for regulatory documents and regulatory submission strategy
  • Act as a functional area representative and lead on product teams
  • Manage, train and mentor medical writers
  • Manage the work of GRW staff
  • Assist with the following activities: hiring, resourcing therapeutic areas and project teams, and departmental governance
  • Ensure quality of regulatory submission documents at all stages of development
  • Provide expertise and guidance on document design and principles of good medical writing to the department and product teams
  • Participate in departmental meetings, as well as departmental and cross-departmental initiatives, as appropriate
What we expect of youWe are all different, yet we all use our unique contributions to serve patients.Basic Qualifications:
  • Doctorate degree and 13-15 years of Writing Regulatory or scientific submission/documents experience OR
  • Master’s degree and 15-17 years of Writing Regulatory or scientific submission/documents experience OR
  • Bachelor’s degree and 16-18 years of Writing Regulatory or scientific submission/documents experience
Preferred Qualifications:
  • BS, MS or higher degree in biology, chemistry or other scientific discipline
  • Experience in writing clinical and regulatory documents
  • Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment
  • Ability to analyze medical data and interpret its significance
  • Advanced knowledge of scientific/technical writing and editing and of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry compliance
  • Advanced written/oral communication skills and attention to detail
  • Understanding and application of principles, concepts, theories and standards of scientific/technical field
  • Strong time and project management skills, negotiating skills, and perseverance with a drive for results
  • Knowledge of management skills and supervising the work of others
  • Strong leadership in a team environment
  • Strong negotiator
  • Experience in mentoring, training, and directing others
What you can expect of usAs 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 nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAs 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..

Amgen