Grad Intern R&D Global Regulatory Writing

Career Category

College Job

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Grad Intern - R&D Global Regulatory Writing

What You Will Do

Lets do this. Lets change the world. During this program you will help prepare scientific and regulatory submission documents that comply with global regulatory standards.

• Understands and complies with SOPs templates best practices policies Amgen Style Guide
• Writes and edits sections of non-complex regulatory documents (eg simple clinical study report CSR investigator brochure) and simple standalone documents (eg patient narratives) with mentor oversight as defined by the organization
• Reviews their own draft document content with mentor for feedback
• 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
• Participates (under close supervision) in project management activities ie timeline tracking and scheduling meetings with team members
• Generates appropriate in-text tables and figures
• Performs document-level QC (including abbreviations references to sources data in text versus data in tables figures or graphs etc.)
• 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 projects
• Documents in scope include CSRs / observational research study reports plain language summaries IBs risk management plans original protocols / informed consent forms / amendments nonstrategic regulatory documents

What We Expect of You

We are all different yet we all use our unique contributions to serve patients. The innovative proactive individual we seek is a problem solver with these qualifications :

Basic Qualifications :

Amgen requires that all individuals applying for a grad internship t at Amgen must meet the following criteria :

Preferred Qualifications :

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 well support your journey every step of the way.

The base pay range for this opportunity in the U.S. is $30-$40 per hour

Apply now and make a lasting impact with the Amgen team.

In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Sponsorship

Candidates must be authorized to work in the U.S. for the duration of this program. Sponsorship for future FTE roles is not guaranteed.

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.

Salary Range

Required Experience :

Intern

Key Skills

Laboratory Experience,Vendor Management,Design Controls,C / C++,FDA Regulations,Intellectual Property Law,ISO 13485,Research Experience,SolidWorks,Research & Development,Internet Of Things,Product Development

Employment Type : Full-Time

Experience : years

Vacancy : 1

Hourly Salary Salary : 30 - 40