Project Specialist II

Additional Location(s): US-MA-Marlborough; US-MA-Bedford; US-MA-Boston; US-MA-Burlington; US-MA-Cambridge; US-MA-Lexington; US-MA-Lowell; US-MA-Natick; US-MA-Quincy; US-MA-Western/Springfield; US-MA-Worcester; US-MN-Arden Hills; US-MN-Mankato/Rochester; US-MN-Maple Grove; US-MN-Minneapolis; US-MN-Minnetonka; US-MN-Northern/Duluth; US-MN-Plymouth

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About the role:

The Project Specialist II will work as a team member on the Global Medical Affairs team to support clinical evaluation needs cross-divisionally, operating in a coordinated, integrated manner, and engaged in best practices that will deliver value back to the organization across the product lifecycle. The role entails combining the understanding of Project Management principles with scientific and research methodology to develop strategic solutions to EU MDR clinical evidence and risk management requirements for Boston Scientific in partnership with management. As a Project Specialist II, you will enjoy a high degree of organizational latitude and will have accountability and responsibility for project planning, leadership, and success.

Your responsibilities will include:

• Assembling and driving large cross-functional project teams, identifying resources required, and developing detailed cross-functional project plans to ensure the on-time completion and launch of projects. Formulating the project plan, in accordance with the goals and timing, set by management.
• Leading the project, within the project budget and program strategy, in terms of quality, money, time, information and organization, monitoring progress and managing external resources (if any).
• Acting as a liaison with project stakeholders and effectively communicating project expectations to team members and stakeholders in a timely and clear fashion.
• Actively evaluating the project for opportunities to improve performance; as well as continuously monitor risk and mitigate as appropriate.
• Assisting with activities and projects related to Clinical Evaluation Plans [CEPs], Clinical Evaluation Reports [CERs], Post-market Clinical Follow-up [PMCF] Plans, PMCF Evaluation Reports, and Summary of Safety and Clinical Performance [SSCP], etc. in alignment with applicable clinical and regulatory standards and business needs. 
• Supporting Clinical Evaluation related processes impacting QMS

Required qualifications: 

• Bachelor's degree plus 2-4 years of related work experience or an equivalent combination of education and work experience.
• The position is technical in nature and the applicant must have experience in clinical research, clinical affairs, regulatory affairs, or quality systems, in the medical device or pharmaceuticals industry.
• Analytical skills, including ability to review and synthesize medical literature efficiently and effectively. 
• Strong sense of responsibility and urgency. Ability to take ownership of projects.
• Flexibility and ability to manage simultaneous priorities, and changing deadlines.

Preferred qualifications: 

• 1-3+ years of project coordination/project management experience.
• Experience with MEDDEV 2.7/1 Rev 4, the medical device directives (MDD 93/42/EEC; AIMDD 90/385/EEC) and the EU MDR 2017/745.
• Demonstrate strong leadership, verbal, and written communication skills, with ability to navigate a fast-paced environment, develop solution driven teams and manage multiple projects simultaneously in a tight deadline driven environment.
• Proficient in the use of Microsoft Office suite (especially Microsoft Word and PowerPoint)
   

Requisition ID: 560405

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.