Syneos Health, Inc.
Sr Regulatory Associate PM (US or LATAM Based Only)
Syneos Health, Inc., Trenton, New Jersey, United States
Sr Regulatory Associate PM (US or LATAM Based Only)
Updated:
Yesterday Location:
USA-NJ-Remote Job ID: 25100633
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
WORK HERE MATTERS EVERYWHERE Why Syneos Health
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Job Responsibilities
Under limited supervision, performs detailed and confidential project-related duties directly related to regulatory submissions and regulatory compliance.
May also perform limited general project administrative duties.
Creates and edits regulatory reports, summarizes data in the public domain, conducts quality control review of documents, and may also collect and analyze data to produce reports to support INDs, NDAs/MAAs, DMFs, variations, renewals, MATs, and other lifecycle maintenance activities.
Prepares and submits full application or components of IND, marketing and lifecycle maintenance applications to ensure compliance with government acts and regulations.
Undertakes information processing activities with extremely high reliability, high quality and tight timelines according to standard processes and operating procedures.
Undertakes project specific activities with minimal supervision from senior colleagues within cost and time estimates/contracts.
Prepares records and/or logs and updates regulatory databases as per Syneos Health and/or client requirements.
Conducts quality control reviews of documents and tracks them until final submission or delivery to client.
Attends client meetings as needed and builds client relationships in support of projects and deliverables.
Systematically reviews Regulatory Associates or other Senior Associate’s work, performance, and productivity tracking, coordinating with project manager and director for coordination of the project.
Identifies risks to project delivery related to own workload and appropriate escalation; for identified non-complex issues, provides proposals for issue resolution.
Assists in training and mentoring of team members depending on project requirements.
Creates and maintains content plans within Veeva Vault RIM.
Translates Smartsheet timelines into Microsoft Project and Veeva Vault RIM.
Assists with planning, managing, and tracking of regulatory submissions.
Qualifications - External
3-5 years of Regulatory Experience within Industry.
BS/BA degree or equivalent practical experience.
Experience in a work-related area preferred.
Excellent interpersonal/communication skills.
Advanced skills in Microsoft Office Applications.
Strong analytical skills.
Ability to work independently and understand and carry out detailed instructions.
Ability to interact with staff from multiple departments.
Ability to work concurrently on projects, each with specific instructions that may differ from project to project.
Fluent in speaking, writing, and reading English.
In-depth understanding of regulatory requirements and guidelines including FDA regulations, EMA guidelines and ICH standards. Keywords: eCTD, NDA, IND, EU CTA, MAA, EU CTR, NDS.
Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Salary Range:
$47,000-$79,900 USD . The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.
Summary Clinical - Regulatory submission and project management.
Equal Opportunity Statement Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: jobs@syneoshealth.com
#J-18808-Ljbffr
Updated:
Yesterday Location:
USA-NJ-Remote Job ID: 25100633
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
WORK HERE MATTERS EVERYWHERE Why Syneos Health
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Job Responsibilities
Under limited supervision, performs detailed and confidential project-related duties directly related to regulatory submissions and regulatory compliance.
May also perform limited general project administrative duties.
Creates and edits regulatory reports, summarizes data in the public domain, conducts quality control review of documents, and may also collect and analyze data to produce reports to support INDs, NDAs/MAAs, DMFs, variations, renewals, MATs, and other lifecycle maintenance activities.
Prepares and submits full application or components of IND, marketing and lifecycle maintenance applications to ensure compliance with government acts and regulations.
Undertakes information processing activities with extremely high reliability, high quality and tight timelines according to standard processes and operating procedures.
Undertakes project specific activities with minimal supervision from senior colleagues within cost and time estimates/contracts.
Prepares records and/or logs and updates regulatory databases as per Syneos Health and/or client requirements.
Conducts quality control reviews of documents and tracks them until final submission or delivery to client.
Attends client meetings as needed and builds client relationships in support of projects and deliverables.
Systematically reviews Regulatory Associates or other Senior Associate’s work, performance, and productivity tracking, coordinating with project manager and director for coordination of the project.
Identifies risks to project delivery related to own workload and appropriate escalation; for identified non-complex issues, provides proposals for issue resolution.
Assists in training and mentoring of team members depending on project requirements.
Creates and maintains content plans within Veeva Vault RIM.
Translates Smartsheet timelines into Microsoft Project and Veeva Vault RIM.
Assists with planning, managing, and tracking of regulatory submissions.
Qualifications - External
3-5 years of Regulatory Experience within Industry.
BS/BA degree or equivalent practical experience.
Experience in a work-related area preferred.
Excellent interpersonal/communication skills.
Advanced skills in Microsoft Office Applications.
Strong analytical skills.
Ability to work independently and understand and carry out detailed instructions.
Ability to interact with staff from multiple departments.
Ability to work concurrently on projects, each with specific instructions that may differ from project to project.
Fluent in speaking, writing, and reading English.
In-depth understanding of regulatory requirements and guidelines including FDA regulations, EMA guidelines and ICH standards. Keywords: eCTD, NDA, IND, EU CTA, MAA, EU CTR, NDS.
Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Salary Range:
$47,000-$79,900 USD . The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.
Summary Clinical - Regulatory submission and project management.
Equal Opportunity Statement Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: jobs@syneoshealth.com
#J-18808-Ljbffr