Additional Locations: Costa Rica-Heredia

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

At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.

Hybrid Roles:

Boston Scientific’s hybrid workplace includes Working From Home and onsite. You will have the opportunity to discuss details in the interview. 

About the role:

The Scientific Communications Manager is primarily responsible for clinical evaluation and post-market clinical follow-up (PMCF) documentation for the BSC Urology Division, acting as a people leader and functional leader to drive process and strategy at the portfolio level. This role will split time between leading clinical evaluation projects and leading people, with the balance of effort shifting as the number of direct reports grows over time. Typical deliverables include clinical evaluation plans and reports (CEP/CER), post-market clinical follow-up plans and evaluation reports (PMCF-P/PMCF-ER), and PMCF activity reports. This role serves as the Scientific Communications lead on cross functional teams supporting product approval, market expansion, and mandated post-market requirements in close partnership with Regulatory Affairs, Research & Development, Design Quality Assurance, Clinical Strategy, Clinical Operations, and Medical Safety.

 Your responsibilities include:

• Lead the expansion of the Urology Scientific Communications team in Costa Rica by hiring, training, and managing a new team of Scientific Communications Specialists.
• Lead the development of CERs and related documents (CEPs, PMCF Plans, PMCF Reports, SSCPs) by evaluating clinical investigation data, PMCF data, and scientific literature; reviewing hazard analyses and other risk documents, reviewing product complaint data, analyzing scientific data, and staying abreast of current clinical practice. 
• Lead project teams to define scope and generate state of the art reports characterizing disease states, clinical outcomes, and therapeutic alternatives for assigned device portfolios. 
• Lead the development of clinical evaluation strategy, including clinical evidence requirements to support indications and clinical benefits, defining safety and performance objectives, and PMCF requirements for a portfolio of products.
• Establish resource plans in collaboration with the Sci Comm leadership team to meet document timelines required by BSC procedures, product development teams, and global Regulatory Bodies.
• Proactively track and report progress towards goal achievement, KPIs, and metrics.
• Lead and facilitate individual and team development activities (e.g. establishing individual development plans, intentionally assigning work to facilitate skills development, setting agendas for and leading team meetings, knowledge sharing, training, mentoring, team building).
• Serve as functional reviewer for team deliverables.
• Proactively identify process improvement opportunities and lead the development and implementation of improved workflows.
• Contribute to cross-divisional communities of practice and centers of excellence.
• Interact with regulatory agencies as needed, by providing front- and back-room audit support or addressing clinical queries in support of product safety and performance; lead audit readiness activities.
• Effectively collaborate across functions on new product development and sustaining core teams, providing clinical evaluation deliverables and expertise to cross-functional deliverables.
• Provide input into hazard analyses and instructions for use for assessment of potential harms and support of product safety and performance.
• Review cross-functional deliverables, including risk documentation and PSURs for assigned products.
• Demonstrate advanced understanding in evolving requirements of international regulations, including requirements laid out in EU MDR.

What we’re looking for in you:

Minimum Qualifications

• Master’s Degree with 10+ years of related work experience or Bachelor’s degree with 10+ years of related work experience (Clinical Evaluation / Medical Writing / Clinical Trials / Medical Affairs / Epidemiology)
• Knowledge of clinical research methodologies (clinical investigation design and biostatistics, systematic literature review)
• Demonstrated project management and cross-functional team leadership of long-term projects from initiation to completion
• Experience writing CERs and related documents compliant with EUMDR
• Ability to analyze, interpret, and summarize scientific data and medical literature
• Working knowledge of Adobe PDF, MS Word, and Excel
• Ability to use in-depth clinical knowledge in cross functional team meetings
• Proven ability to solve complex problems through effective collaboration
• Proven ability to manage timelines
• Please submit Resume In English

Preferred Qualifications

• Advanced Degree preferred (PhD, PharmD, MD)
• Experience as a people leader
• Experience with information management (experience with relevant databases such as PubMed, Ovid, or Embase)
• Experience with literature management software such as Distiller and EndNote

Internal candidates requirements:

• A year in the current position, in the company.
• Performance Evaluation: Successful or above
• Don’t have disciplinary actions in the last 6 months.

Requisition ID: 600087

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!

Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination, and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.