Job details

Sr. Labeling Project Specialist Contractor- Marlborough, MA

RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.

The Senior Labeling Project Specialist (LPS) plans, manages, trains, and directs the creation and revision of product literature and labeling through their own work and through others. The LPS works closely with project teams to ensure labeling content is developed per, and compliant to, all applicable procedures, regulations, and standards. The LPS ensures labeling deliverables are completed per the schedule and maintains a high standard of quality.

The LPS will work to streamline processes, cross-train personnel, and continuously improve. The LPS will engage with stakeholders and work collaboratively across functions, regions, and business units. The LPS is the resident expert and primary point of contact for all things related to product literature and labeling. 

12 Month Contract

Responsibilities:

Managing product labeling projects.
Developing labeling project strategies and schedules to outline work plans, timelines, roles, and resources. Anticipate potential barriers and develop alternatives and mitigation strategies.
Facilitating training on labeling procedures and labeling software and systems.
Leading product labeling project teams to complete activities per policies and practices to produce and release product labeling deliverables.
Effectively communicating project statuses, challenges, and successes on a regular basis to project and functional management in various meetings.
Ensuring on-time completion of deliverables.
Monitoring and working with project management and functional management to address issues that could negatively impact schedule or quality.
Coordinating all product labeling deliverables (will vary by project), including labels, IFUs, and carton and pouch artwork, etc.
Leading cross functional teams through content development for labeling deliverables by managing the drafts, collecting input and source data, making changes, tracking revisions, and keeping teams on schedule.
Fostering and improving content consistency across labeling.
Facilitating team reviews of labeling deliverables to ensure content is accurate, complete, fully compliant to relevant regulations and requirements, and meets the needs of the customer.
Coordinating desktop publishing and labeling artwork generation.
Coordinating implementation/release activities of labeling deliverables, including elabeling.
Managing content changes (and mitigating the impact on schedule and consistency) by pushing teams to focus on accuracy and completeness.
Leveraging expertise with labeling procedures, requirements, and quality system to ensure all deliverables are fully compliant and free of errors.

Requirements:

Associate degree or bachelor’s degree
7+ years’ work experience in regulated industry
Medical Device experience
5+ years Labeling experience
Direct labeling or technical writing experience desired
High attention to detail
Ability to manage several projects concurrently
Ability to learn new skills and adapt to business needs
Medical Electrical Equipment / Capital Equipment experience
Adobe Suite Creative Suite experience strongly preferred
MS Office and MS Project experience strongly preferred
Project Management experience
Prisym, Bartender or other label design software and database experience preferred
Scrum and agile methodology experience preferred
Ability to travel up to 15% including some international travel

Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!

We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.

Job Opportunity Verification

At RQM+, we prioritize the security of our job applicants. To ensure a safe application process:

All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers

Every candidate going through the interview process will participate in a voice and/or video interview.

Exercise caution with unsolicited job offers or requests for sensitive information.

RQM+ Glassdoor Company Review

2.9

RQM+ DE&I Review

No rating

CEO of RQM+

MARGARET KEEGAN

Approve of CEO

Average salary estimate

$100000 / YEARLY (est.)

min

max

$90000K

$110000K

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What You Should Know About Sr. Labeling Project Specialist Contractor- Marlborough, MA, RQM+

Are you ready to take your project management skills to the next level? At RQM+, we are looking for a passionate and experienced Sr. Labeling Project Specialist Contractor to join our team in Marlborough, MA. As the leading MedTech service provider, we have built our reputation on 40 years of regulatory expertise, providing our clients with top-notch clinical trial, lab, and reimbursement services. In this role, you’ll be at the forefront of developing and managing product literature and labeling, ensuring compliance with all relevant regulations. You’ll lead project teams, streamline processes, and train your colleagues, creating a collaborative atmosphere where great ideas thrive. Your ability to multitask and maintain high-quality standards will be key as you oversee numerous labeling projects simultaneously, all while ensuring timely completion of deliverables. We pride ourselves on our commitment to continuous improvement, and you’ll play a vital role in driving that initiative. You’ll interact with stakeholders across various functions and regions, becoming the go-to expert for all matters related to product labeling. Your experience in the medical device industry, combined with your project management prowess, is exactly what we need to shift our operations into high gear. At RQM+, every team member’s contribution counts, and we can’t wait to see the impact you’ll make!

Frequently Asked Questions (FAQs) for Sr. Labeling Project Specialist Contractor- Marlborough, MA Role at RQM+

What are the responsibilities of the Sr. Labeling Project Specialist at RQM+?

The Sr. Labeling Project Specialist at RQM+ is responsible for managing product labeling projects, developing labeling strategies, facilitating training, and leading project teams to ensure compliance with policies and industry standards. The role also involves coordinating deliverables like labels and packaging designs, communicating project statuses, and fostering content consistency across all labeling materials.