Grad Intern R&D Global Regulatory Writing at Amgen

Career CategoryCollege JobJob DescriptionJoin Amgens Mission of Serving PatientsAt 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 WritingWhat You Will DoLets 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 GuideWrites 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 organizationReviews their own draft document content with mentor for feedbackParticipates in collaborative team activities for non-complex documents including support to collect input from authors/reviewersParticipates in the cross-functional document review process comment triage meeting attendance and incorporation of feedback for development of subsequent drafts or for finalizationParticipates (under close supervision) in project management activities ie timeline tracking and scheduling meetings with team membersGenerates appropriate in-text tables and figuresPerforms 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 platformsAttends 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 projectsDocuments in scope include CSRs/observational research study reports plain language summaries IBs risk management plans original protocols/informed consent forms/amendments nonstrategic regulatory documentsWhat We Expect of YouWe 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:18 years or olderGraduated with a bachelors degree from an accredited college or universityCurrently enrolled in an MBA program for an MBA internship OR a Masters program for a Masters internship OR a PharmD program for a PharmD internship OR Ph.D. for a PhD internship from an accredited college or university and completion of the first year of MBA OR Masters OR Pharm D OR Ph.D. program before the internship startsEnrolled in an accredited college or university following the potential internshipMust not be employed at the time the internship startsStudent must be located in the United States for the duration of the internshipPreferred Qualifications:Degree Concentration in Life Sciences Pharmacy Medicine Business or Related FieldExperience in interpretation of scientific dataScientific or medical knowledgeExposure to or working knowledge of basic statistical and medical communication principlesDemonstrated passion for writing and engagement in writing activities (extra-curricular scientific etc.)Strong oral and written communication skills including ability to write scientific documents and summarize scientific dataAble to collaborate with others and to build solid and positive relationships with crossfunctional team membersAble to work independently and to resolve basic problems on their own and more complicated problems under supervisionAttention to detail and accuracyOrganizational skills in time management and in project management; ability to manage more than one project simultaneouslyWorking knowledge of typical office applications (e.g. Microsoft Office SharePoint)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 well support your journey every step of the way.The base pay range for this opportunity in the U.S. is $30-$40 per hourBuild a network of colleagues that will endure and grow throughout your time with us and beyond.Bring your authentic self to the table and become the professional youre inspired to be through accepting a culture that values the diversity of thought and experience and will flex to your strengths and possibilities.Participate in executive and social networking events as well as community volunteer projects.Apply now and make a lasting impact with the Amgen team. - Please search for Keyword R-231226In 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.SponsorshipCandidates 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