The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

Our client is seeking a Clinical Labeling Specialist in New Brunswick, NJ.

Role Description

This position will require person to be onsite full-time during training period with option to work 50% from home after completion of training.

• Supports timely delivery of clinical supplies through effective management of assigned projects.

• Manages multiple projects and tracks all activities and milestones related to assigned projects. Identifies and reports issues to appropriate levels of management in a timely manner.

• Works with external partners to ensure clinical labels are created with exacting specification.

• Generates clinical labeling source documentation as required.

• Reviews and approves vendor generated label proofs/specifications and other related documents.

• Utilizes electronic verification software to perform check on label proof. Routes final label for review and approval accordingly.

• Participates in assigned training including cGMP and safety training

• Ensures regulatory, cGMP, GDP compliance of activities in assigned areas of responsibility. Reports any deviations to the appropriate management.

• Works cross-functionally with individuals and project teams in various areas

• Liaises with responsible Trial Supplies Manager on aspects of clinical supplies packaging and labelling design and study requirements and resolves issues.

Skills & Requirements

• Bachelors degree or equivalent in pharmacy, engineering, business or life sciences

• Ability to plan, manage and execute multiple projects and to deliver against critical timelines in a fast-paced, rapidly changing environment.

• Strong project management skills and detail oriented.

• Possesses solid oral and written communication skills.

• Good decision making and organizational skills.

• Ability to effectively communicate ideas and to influence others to achieve results.

• Ability to understand and apply regulatory and cGMP principles.

• Good understanding of pharmaceutical or medical terminology

• Proficiency in standard MS office technology, including Microsoft Suite (Outlook, PowerPoint, Excel) and additional applications such as Adobe. Willing to learn additional applications as needed

• Experience working on multi-disciplinary teams and projects

• Good knowledge of rigorous pharmaceutical and/or scientific documentation practices and change control processes (e.g. revision control) is preferred.

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’. We also believe that actions speak louder than words. In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

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