Job Description
Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.
As a new addition to our Clinical Supplies-Operations Team, we are looking for a Label Operations Specialist (m/f/d) based in our offices in Schachen, Switzerland (Full-time, indefinite).
On this position you will coordinate internal and external timely label printing activities with various work centers (label design & printing, packaging and quality) and you will serve as the subject matter expert on all label-related matters for both internal and external parties.
THE PRIMARY ACTIVITIES INCLUDE BUT ARE NOT LIMITED TO:
Coordinate job progress (Label Translations, Labels Design and Label Printing) across all applicable work centers.
Track project risks and implement mitigation plans.
Recommend where needed, unique labeling solutions that meet clinical study needs.
Investigate deviations, set follow-ups and write Notices of Event. Act as primary contact in case of deviations and define and implement preventive and corrective actions as applicable.
Act as the main stakeholders for third party packaging companies and negotiate label printing timelines with contract manufacturers and request/review quotes.
Monitor the adherence to project schedules and document progress in the respective databases.
Assist the work centers (Global Project Management, Packaging, Operations Planning, Quality disposition group) for issue resolution as needed.
Provide input and partner with the Operations Planning work center to develop the labeling strategy for the individual clinical products.
Collaborate with global master planning and project management (demand and supply project managers) to establish priorities across different projects.
Act as a subject matter expert on the label operations process for both internal and external parties.
Write and review global standard operating procedures (SOP) in English and German.
QUALIFICATIONS:
Technical Skills:
Bachelor’s degree in a scientific, business, or related discipline
2+ years of experience with GMP requirements
Experience in a clinical supply related area (planning, scheduling, coordination, Label Operations ,etc.) would be highly preferred
Hands-on experience with quality procedures
2+ years of experience in SOP writing and SOP execution
Proficiency in Microsoft applications (Word, Excel, PowerPoint)
Minimum of 2+ years hands-on experience in Project Management within the pharmaceutical industry
Business fluency in German, C2- native level
English knowledge at an intermediate level, B2-level
SAP knowledge would be preferred
Personal competences:
Excellent ability to multi-task, flexibility and high self-organizational skills
Ability to prioritize tasks and cope with a changing, diverse workload
Detail oriented and proactive
Team oriented and able to work independently
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
THE COMPANY…
Our company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Weystrasse, Citybay, Schachen and Kriens). A fifth location has been recently established in Zurich, aimed at accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our mission to save and improve lives around the world. The new location has a target date of 2021 for operational readiness.
We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us.
Our Werthenstein BioPharma site in Schachen is where we conduct cutting-edge research, develop and analyze new biological agents, produce new products and supply clinical trial products for global clinical studies. The site is also home to one of our global forensic laboratories where we carefully monitor our products through the supply chain to ensure security and safety for our patients.
WHO WE ARE …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
WHAT WE LOOK FOR …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
INVENT.
IMPACT.
INSPIRE.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
Not SpecifiedShift:
Not IndicatedValid Driving License:
Hazardous Material(s):
noNumber of Openings:
1Requisition ID:R95284