Job Summary

Responsibilities

Labeling Team scope includes development of strategy, creation, and management of global labeling requirements, specifications and released artwork for multiple types of manuals, instructions for use, package serts, release notes, product & package labeling in addition to Global UDI and Global electronic instructions for use (eIFU) activities.   Scope of team also includes the implementation and maintenance of labeling related platforms and tools and harmonizing legacy processes and practices across TCT and MedTech locations.  

Interns can expect to participate in global labeling requirements development, labeling & labeling component design (e.g. desktop publishing, technical illustrations),  technical writing, global UDI data / master data collection, eIFU publication, proofreading & editing of label content, translation / localization management across product portfolio for multiple types of labeling deliverables for a variety of medical devices used in blood centers, plasma centers, and hospitals.

Specific activities / projects may include, but are not limited to:

• Review / Revise / Create drawings, specifications, labels, and instructions for use
• Create Charts, Graphs, flow charts, spreadsheets, and / or forms for illustrative conents
• With guidance, run simulated procedures to improve usability of manuals for legacy devices
• With guidance, create / update consistent global labeling requirements (design inputs) for specific products – updating to current standards
• Support the data collection / data clean up of regulated product data for specific product codes for publication across applicable global UDI databases such as FDA GUDID, EU EUDAMED, Australia (New), Saudi Arabia, South Korea,
• Support the implementation and publication of eIFU for specific product lines, including preparing legacy labeling for “electronic portability/ electronic distribution readiness”
• Preparing reports, analytics, and analysis of labeling related metrics related to process / tool performance and identify potential areas for ongoing improvement efforts
• Other labeling team related activities as needed

Requirements

• Intern candidates must be permanently authorized to work in the U.S.
• Our internships are unable to accommodate OPT. 
• Interns are responsible for their own housing.
• Currently enrolled as a student at an accredited college
• Pursuing a degree program in any of the following disciplines; Engineering, Biology, Regulatory, Graphic Arts, Design, Medical Writing, Professional Writing or any other related field.
• Be classified as a minimum of a sophomore.
• Must be planning to return to school at the end of their break
• Design, Graphic Arts, and / or instructional design focus preferred.   
• Technical Writing / Professional writing skills.  
• Microsoft Office Suite, MS Illustrator, Visio, Adobe.
• Ability to distill complex process content to brief, concise, and understandable language and / or illustrations. 
• Curiosity and drive to see how innovative labeling strategies and solutions can bring complex global compliance, business, technical and human factors requirements together. 

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

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CURRENT COREWELL HEALTH TEAM MEMBERS – Please apply through Find Jobs from your Workday team member account. This career site is for Non-Corewell Health team members only.

Corewell Health is committed to providing a safe environment for our team members, patients, visitors, and community. We require a drug-free workplace and require team members to comply with the MMR, Varicella, Tdap, and Influenza vaccine requirement if in an on-site or hybrid workplace category. We are committed to supporting prospective team members who require reasonable accommodations to participate in the job application process, to perform the essential functions of a job, or to enjoy equal benefits and privileges of employment due to a disability, pregnancy, or sincerely held religious belief.

Corewell Health grants equal employment opportunity to all qualified persons without regard to race, color, national origin, sex, disability, age, religion, genetic information, marital status, height, weight, gender, pregnancy, sexual orientation, gender identity or expression, veteran status, or any other legally protected category.

An interconnected, collaborative culture where all are encouraged to bring their whole selves to work, is vital to the health of our organization. As a health system, we advocate for equity as we care for our patients, our communities, and each other. From workshops that develop cultural intelligence, to our inclusion resource groups for people to find community and empowerment at work, we are dedicated to ongoing resources that advance our values of diversity, equity, and inclusion in all that we do. We invite those that share in our commitment to join our team.

You may request assistance in completing the application process by calling 616.486.7447.

1. Near miss reporting tracking, updating and report.
2. Support safety patrol/ audit.
3. PPE trcking record.
4. Support contractor management.
5. Support HSE documents.
6. Scrap area and waste storage area inspection and actions as superior assignment.
7. Join Emergency case practice e.g Fire ,Boiler ,LPG,Water&coolant over Flow ,Radiation ,Chemical ,Covid19 simulation etc.
8. Coordinate and contcat HSE job with department concern.
9. Improve safety videos and digitalization for HSE topics as superior assignement.
10. Safety Road activity support.
11. First Aid room/First aid box inspection.
12. Other health, safety and environmental related tasks as assigned by superior.

Job Overview
Acts as a Lead Medical Writer on straightforward projects (e.g. simpler documents under standard timelines). Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. Negotiates timelines and discusses/resolves customer comments, with senior support as needed.
Keeps abreast of current medical and/or technical writing/regulatory knowledge, including GCP, along with developments and advances in drug development/medical and/or technical writing.

Essential Functions
• Take a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating and adhering to timelines, organizing document reviews, communicating directly with the customer.
• Manage day-to-day workload: identify project needs, track timelines and implement customer requests, keeping manager/senior staff abreast of progress on tasks and any potential problems with project work.
• Attend project team meetings with or without other writers. Participate in/lead comments resolution or similar meetings with external customers.
• May give simple presentation to an existing customer (e.g. on processes at a Kick-off meeting).
• Complete project finance activities, including monitoring and forecasting budgeted hours.
• Awareness of budgets and project finance principles, moving towards review and understanding of budgets relating to assigned projects, including out of scope activities.

Qualifications
• Bachelor's Degree Bachelor's Degree in life sciences related discipline or related field Req
• Master's Degree Master's Degree in life sciences related discipline or related field  Pref
• Ph.D. Ph.D. in life sciences related discipline or related field Pref
• Typically requires 1-3 years of prior relevant experience and related competency levels. Req
• Familiarity with the structural and content requirements of clinical study reports, protocols, and similar documents.
 Req
• Good understanding of common statistical methods used in clinical trials and/or interpretation of their results.
 Req
• Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output Pref
• Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner. Req
• In depth knowledge of drug development, medical writing, and associated regulations. Good understanding of statistical principles and of medical terminology across a range of therapeutic areas. Req
• Excellent written and oral communication skills including grammatical/technical writing skills.
• Excellent attention to detail and accuracy.
• Communicates clearly, effectively and confidently with others.
• Demonstrated abilities in collaboration with others and independent thought.
• Demonstrates confidence and maturity in most routine medical writing situations.
• Demonstrates good judgement in requesting input from senior staff.
• Ability to establish and maintain effective working relationships with coworkers, managers and customers.
• Ability to effectively manage multiple tasks and projects.
• Must be computer literate.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

Job Summary

Responsibilities

As a Medical Affairs Summer Intern, you will be responsible for supporting the Medical Affairs US Biopharma team in various tasks. The role of a Medical Affairs team is to provide scientific and clinical support for commercial products and act as the medical face of a pharmaceutical company.

• Conducting literature reviews and summarizing scientific articles .
• Assisting with the development of scientific materials, such as slide decks and scientific posters .
• Creating Standardized Medical Response letters and supporting other medical information activities.
• Supporting the planning and execution of advisory boards, scientific symposia, and other medical education initiatives .
• Collaborating with cross-functional teams, including Global Medical Affairs, Regulatory Affairs, and Commercial teams .
• Participating in team meetings and presenting on assigned projects. 

Requirements

• Currently enrolled as a student at an accredited school of pharmacy and have completed at least their 2nd year of curriculum
• Be classified as a minimum of a sophomore
• Must be planning to return to school at the end of his/her break
• Strong communication skills, both written and verbal
• Ability to work independently and as part of a team 
• Strong organizational skills and attention to detail
• Ability to analyze complex data sets and summarize finding
• Intern candidates must be permanently authorized to work in the U.S.
• Our internships are unable to accommodate OPT
• Interns are responsible for their own housing

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.