Sr. Project/Program Manager

Location: Boston, MA or REMOTE

Duration: 12 months with possibility to extend or convert, based on business needs and performance

**Please note, in order to convert to FTE a candidate must be local to the Boston site to work a hybrid schedule 3 days in office, 2 days remote)

Pay: $70-73.50 per hour

Description:

We are looking for an experienced Project Manager with a strong background in medical device development - pre-filled syringes and autoinjectors are a BIG PLUS, to join our device group. The successful candidate, under the guidance of the project lead, will manage the end-to-end development of device/combination products. The project manager will collaborate with cross functional teams within and outside of the device group. These may include but are not limited to regulatory, quality, packaging, CMC, CMOs and other functions as required by the project.

Key Responsibilities:

• People leadership, team culture and values:

Successfully manage without authority team of cross functional members, inspire and address conflicts, drive for productive resolution. Acknowledge and embrace productive values, contributing to successful project teams. Lead the implementation and adherence of these values.

• Planning and execution: 

With the guidance of the project lead and collaboration of the project team, facilitate the planning and execution process, including resource allocation and budgets. drive to a predictive plan, adhere to agreed framework and practices.

• Cross-functional Collaboration:

Work closely with CMC, formulation, drug product teams, and other cross functional teams to ensure seamless integration of device and drug components. Facilitate alignment between device development and drug lifecycle activities.

• CMOs management

Serve as the primary device point of contact for external CMOs and device suppliers; oversee timelines, deliverables, and issue resolution.

• Design Controls & Risk Management:

Ensure rigorous application of design control processes per FDA and ISO standards (e.g., ISO 13485, ISO 14971). Lead device project risk assessments and maintain robust documentation (e.g., DHF).

• Regulatory Support:

Coordinate the development of documentation to support regulatory submissions, including combination product sections of INDs, NDAs, and EU dossiers.

• Project Governance:

In partnership with the DRP and project team, the PM will prepare project status reports to the leadership team and governance committees.

• Meeting Facilitation & Communication:

Lead device sub-team meetings, manage agendas and minutes, drive decision-making and issue resolution, and ensure alignment across all functions.

Qualifications:

• Bachelor’s degree in engineering, life sciences, or related technical field (Master’s preferred)

• 5+ years of project management experience in medical device or combination product development

• Strong working knowledge of combination product regulations (21 CFR Part 4), design controls, and risk management principles

• Excellent cross-functional collaboration skills with various functions and groups

• PMP certification or equivalent preferred

• Proficient in project management software (MS Project, Smartsheet, Jira) and communication tools

Preferred Skills:

• Proven experience leading development of pre-filled syringes and/or autoinjectors.

• Demonstrated experience working with external CMOs and device suppliers

• Experience with technology transfer and device commercialization

• Familiarity with clinical supply chain and regulatory submission processes for combination products

• Exposure to global regulatory pathways including FDA, EMA, and other international agencies

• Understanding of human factors engineering and usability testing in device development

Benefits:

When it comes to working, we want to help take some of life’s pressures off - where we can. So, Kelly employees get access to great benefits, perks, and discounts.

•     EnrollVB Program

     ► Teledoc    ► Supplemental Medical    ► Min. Essential Coverage

    ► Dental        ► Vision            ► Legal & Financial

    ► Accident    ► Short Term Disability    ► Critical illness

    ► Term Life    ► Whole Life

•     Access 2 Wellness - lower medication costs 

•    Kelly’s Life Advisor Wellness Program - access to counselors to assist with a wide range of issues, including Life Coaching sessions

•     Retirement Savings

•     Direct Deposit.  Weekly pay

•     Free skills enhancement and training with More than 6,000 courses and 55,000 eBooks and publications are available

•    Employee Discounts/Perk Spot - Thousands of popular retailers and service providers, you can obtain discounts for almost anything you can buy.

•    Holiday and Service plans where applicable