Clinical Affairs Specialist 3 - Sunnyvale, United States - Intuitive

Intuitive Sunnyvale, United States

2 weeks ago

Description

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Primary Function of Position

This position reports to the Manager, Clinical Affairs, Advertising & Promotion (A&P) Review and is mainly responsible for reviewing A&P material for conformance to known clinical evidence landscape and applicable A&P guidelines and regulations, with potential for future additional clinical responsibilities including literature review and medical writing such as study protocols, clinical study reports, and peer-reviewed publications. This position will also provide clinical guidance during the review and the development of marketing material based on clinical evidence. The candidate will be required to be capable of interpreting results from published literature and be able to correlate a clinically meaningful understanding to marketing materials in accordance with the desired messaging.

As a key cross-functional constituent, this employee will work closely with functions across the organization - Marketing, Regulatory Affairs, Clinical Development Engineering (CDE), Global Access Value Economics (GAVE), and commercial functions to ensure scientific accuracy and meet business priorities.

This position requires being on-site at the Sunnyvale, CA locations 3-4 times per year.

Essential Job Duties

Critically review clinical content in promotional material and provide consultancy to cross-functional stakeholders to ensure a balance of messages and relevance of the content in accordance with applicable medical device regulations and available clinical evidence.
Ensure content is adequately substantiated by scientific data (verifying the content is accurately cited and properly referenced); check authenticity and validity of references; establish that references in promotional materials specifically support clinical claims made in the material; and ensure the context of the reference is appropriately reflected in the promotional claims in the material.
Provides clinical affairs guidance in partnership with regulatory affairs and marketing during the development of marketing materials as needed.
Pursues and comprehends diverse viewpoints from internal and external key stakeholders to provide risk assessment and mitigation strategies as well as effective negotiation leading to resolution for approval of marketing materials.
Support and/or provide training or develop internal guidance documents related to best practices for clinical claim development and substantiation.
May assist with development of clinical literature reports or other clinical documents such as protocols, clinical study reports, and peer-reviewed publications.
Ensure compliance with corporate (e.g., SOP's) and regulatory requirements (e.g., GCP and US and OUS guidelines)

Qualifications

Required Skills and Experience

Knowledge Requirements: (Ability is based on: education, training, skills, and experience.) In order to adequately perform the responsibilities of this position, the person must have:

At least 2-4 years of experience in clinical research, medical sciences, outcome research, clinical evaluation, or medical writing. Experience in the medical device industry is preferred.
The ability to develop subject matter expertise in outcome data from clinical studies in a variety of clinical specialties (such as urology, gynecology, general, and thoracic surgery).
Significant knowledge of clinical study design, outcomes research, and critical review of literature. Knowledge of Good Clinical Practice and 21 CFR Part 812.
Basic understanding of statistics and statistical methods commonly used in peer-reviewed articles.
Excellent ability to interact with internal and external stakeholders. Ability to work effectively and collaboratively on cross-functional teams, including marketing, engineering, regulatory affairs, etc.
Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing.
Excellent critical and analytical thinking skills.
Exceptional communication, presentation, and interpersonal skills with a high level of attention to detail, accuracy, and organization.
Ability to learn quickly and self-educate on different surgical specialties (Self-starter attitude)
Results-driven attitude and excellent problem-solving skills, consistently shows dedication or solid work ethic to help meet aggressive timelines or multiple projects when necessary.

Required Education and Training

MD, PhD, or M.S. degree in a medical, bioengineering, or scientific field is desired.
Must have a minimum of 2-4 years of clinical research with medical writing experience.

Preferred Skills and Experience

Understanding of US FDA advertising /promotional regulations is a plus.
Veeva PromoMats review experience is a plus.
Experience in partnering with KOLs in publication development is a plus.
Experience in authoring clinical protocols, study reports, or EU MDR clinical evaluation is a plus.

Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.

Regulatory Affairs Senior Specialist

4 hours ago

Cepheid Sunnyvale, United States

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved ...
Regulatory Affairs Specialist-4694

3 weeks ago

Infosoft Palo Alto, United States

One of our clients is looking for a talented and highly motivated **Sr. Regulatory Affairs Specialist**. Please **send your resume** if you would like to pursue this opportunity and you authorize Infosoft to represent you for this position. · Here are the job position details for ...
Regulatory Affairs Specialist

3 weeks ago

iHealth Labs Sunnyvale, United States

Job Description · Job Description · Work Location: Sunnyvale, California Salary Range: $90,000 - $100,000 · Job Type: Full-Time Onsite · Our Company: · Founded in 2010, iHealth Labs is dedicated to empowering people to live healthier lives. The company is a leading provider of ...
Regulatory Affairs Specialist

2 weeks ago

iHealth Labs Sunnyvale, United States

Job Description Job Description Work Location: Sunnyvale, California Salary Range: $90,000 - $100,000Job Type: Full-Time OnsiteOur Company:Founded in 2010, iHealth Labs is dedicated to empowering people to live healthier lives. The company is a leading provider of cloud-connected ...
Regulatory Affairs Specialist

3 weeks ago

LanceSoft Santa Clara, United States

Job Title: Regulatory Operations · Location: Santa Clara, CA 95054 · Duration: 6 Months · Description / Summary: · This role will provide compliance support to the Regulatory Affairs organization by · a. Driving preparation of KPI dashboards and maintaining a pulse on formal ...
Regulatory Affairs Specialist(W2 Only)

3 weeks ago

Infosoft Teksolutions Palo Alto, United States

Here are the job position details for your review: · Job Title**:Regulatory Affairs Specialist (W2 Only)** · Pay Rate**:$63 to $68.89/HR** · Duration**:12 months** · Location**:Palo Alto, CA (Hybrid - 2 days/week onsite)** · **Must have skills on the Resume**: · - **Product Regis ...
Regulatory Affairs Specialist

2 weeks ago

Ihealth Labs Inc Sunnyvale, United States

Job Description · Job DescriptionWork Location: Sunnyvale, CaliforniaSalary Range: $90,000 - $100,000 · Job Type: Full-Time Onsite · Our Company: · Founded in 2010, iHealth Labs is dedicated to empowering people to live healthier lives. The company is a leading provider of cloud- ...
Senior Regulatory Affairs Specialist

1 week ago

Abbott Santa Clara, United States

Job Description · Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and bra ...
Senior Regulatory Affairs Specialist

1 week ago

Abbott Santa Clara, United States

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...
Sr. Regulatory Affairs Specialist

2 weeks ago

Amazon, Inc. Sunnyvale, United States

· Amazon Devices and Services is an innovative research and development company that designs and engineers high-profile consumer electronics. We are known for creating the Kindle family of products, and groundbreaking devices like Fire tablets, Fire TV and Echo Frames. Working a ...
Sr. Regulatory Affairs Specialist

3 weeks ago

Amazon Sunnyvale, United States

Amazon Devices and Services is an innovative research and development company that designs and engineers high-profile consumer electronics. We are known for creating the Kindle family of products, and groundbreaking devices like Fire tablets, Fire TV and Echo Frames. Working as p ...
Sr. Regulatory Affairs Specialist

3 weeks ago

Amazon Inc Sunnyvale, United States

· Amazon Devices and Services is an innovative research and development company that designs and engineers high-profile consumer electronics. We are known for creating the Kindle family of products, and groundbreaking devices like Fire tablets, Fire TV and Echo Frames. Working a ...
Regulatory Affairs Specialist

4 weeks ago

GForce Life Sciences Santa Clara, United States

Regulatory Affairs Specialist II Santa Clara, CA · Must be able to work on a W2 · Job Summary · We're looking for a Regulatory Specialist with 2-5 years of experience in the medical device industry. Your responsibilities include maintaining the quality system, supporting man ...
Regulatory Affairs Specialist

3 weeks ago

GForce Life Sciences Santa Clara, United States

Regulatory Affairs Specialist– Santa Clara, CA · Must be able to work on a W2 · Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and comme ...
Regulatory Affairs Specialist

3 weeks ago

GForce Life Sciences Santa Clara, United States

Regulatory Affairs Specialist Santa Clara, CA · Must be able to work on a W2 · Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and comm ...
Regulatory Affairs Specialist

1 week ago

GForce Life Sciences Santa Clara, United States

Regulatory Affairs Project Lead– Santa Clara, CA · Must be able to work on a W2 · Job Summary: · We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and c ...
Regulatory Affairs Specialist

12 hours ago

MILLENNIUMSOFT San Jose, United States

Position: Regulatory Affairs Specialist · Location: San Jose, CA · Duration: 12+ Months Contract · Total Hours/week: 40.00 · 1st Shift: Work hours: 8AM 5PM · Client: Medical Device Company · Job Category: Regulatory Affairs / Compliance · Level Of Experience: Seniority Lev ...
Regulatory Affairs Specialist

1 week ago

Align MD San Jose, United States Freelance

Join a team that is changing millions of lives. · Transforming smiles, changing lives. · At Align Technology, we believe a great smile can transform a person's life, so we create technology that gives people the confidence to take on whatever's next. We revolutionized the ortho ...
Sr. Regulatory Affairs Specialist

1 week ago

Intuitive Sunnyvale, United States

Company Description · At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. · As a pioneer and market leader ...
Sr. Regulatory Affairs Specialist

3 weeks ago

Intuitive Sunnyvale, United States

Company Description · At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. · As a pioneer and market leade ...