Technical Writer

Kelly Services-Portugal; Raynham (MA); Remote; USD 90,000 - 130,000; Full time

Benefits offered by this job

Remote work

Full benefits

Paid time off

401K and retirement benefits

Job summary

Kelly Science & Clinical FSP seeks a Sr. Technical Writer for a remote opportunity supporting a Medical Device client. The role provides oversight and execution of CER and SSCP reports within Kelly FSP, a managed service provider unit.

The writer will mentor junior teammates, perform technical reviews for regulatory compliance, and collaborate across the team to meet project timelines. This full-time position offers comprehensive benefits and a flexible work arrangement.

Qualifications

• Experience with CER regulatory requirements, evidence generation and CER document creation.
• Strong verbal communication skills and interpersonal relationships.
• Familiarity with clinical research, quality/regulatory compliance and adverse event processes.

Responsibilities

• Plan and write CERs and SSCPs and mentor junior technical writers.
• Conduct technical reviews to ensure accuracy and regulatory compliance.
• Collaborate with team members to address contributor needs and timelines.
• Manage daily activities to meet project timelines and deliverables.
• Participate in workshops to improve process efficiency and regulatory understanding.
• Support audits and inspections as subject matter authority when needed.

Skills

CER regulatory requirements

Clinical research knowledge

Verbal communication

Interpersonal relationships

Education

BA/BS/BSN degree

Job description

Kelly Science and Clinical FSP is currently seeking a Technical Writer for a remote opportunity supporting our Medical Device client. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you will be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time.

The Sr. Technical Writer provides oversight and execution of Clinical Evaluation Reports (CER) and Summary of Safety and Clinical Performance Reports (SSCP)

DUTIES & RESPONSIBILITIES

• Under supervision and in accordance with all applicable federal, state and local laws/regulations and Corporation's procedures and guidelines, this position is responsible for: Planning and writing CERs and SSCPs and mentoring junior technical writers.
• Conducting technical reviews to ensure document accuracy and compliance to local procedures, guidelines and regulatory requirements.
• Partnering with team members to address needs of each contributor.
• Managing daily activities to ensure timelines are met.
• Participating in workshops and other initiatives to help define and continuously improve process efficiency.
• Participating in continuous education activities to improve understanding of associated regulatory requirements and industry trends/practices.
• Supporting and, at times, acting as a subject matter authority during audits and inspections pertaining to processes and reports.
• Responsible for communicating business related issues or opportunities to next
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

EXPERIENCE AND EDUCATION

• BA, BS, or BSN is required; advanced degree is preferred

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

• Experience within the medical device industry and knowledge of CER regulatory requirements, evidence generation, and CER document creation
• Strong verbal communication skills and interpersonal relationships
• Demonstrated knowledge and experience in clinical research, quality regulatory compliance, adverse event reporting, medical device risk management process, and common statistical methods is preferred

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources.

Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type.

• Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability.
• As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account.
• In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.

Why Kelly Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.