Remote Drug Safety Associate Jobs in New Rochelle, NY

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.

Discover what our 29,000 employees, across 110 countries already know:

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

Works hand-in-hand with RWLP management, business development, and operations personnel to develop and win global business opportunities; helps to lead the development and delivery of project proposals, bid defenses, and represents capabilities presentations.

Provides overall scientific oversight of selected projects, responsible for meeting or exceeding customer expectations for timelines, budgets, quality, and overall satisfaction.

Coordinates with the project manager to oversee the scientific aspects of study start-up and ongoing study management. Leads the development of and/or peer-review essential study documents including the protocol, case report forms, statistical analysis plan, study management plans, and interim/final study reports. Facilitates scientific advisory boards for safety studies and produces scientific reports/manuscripts/abstracts/presentations.

Maintains a strong working understanding of clinical and epidemiological practice guidelines, clinical research models, protocol designs, real-world research development trends, and regulatory expectations and develops trainings for RWLP/Company organization to enhance their familiarization of epidemiologic study designs and applicable guidelines.

Responsible for the continued building of organizational capacity, improvement of scientific and operational processes and methodologies for non-traditional site management tasks (i.e., remote or central monitoring approaches, minimized regulatory document collection, etc.), integrated RWLP technology solutions including secondary database resources, and RWLP Standard Operating Procedures (SOP) development and maintenance.

Works collaboratively across the organization to help develop business opportunities in the area of post marketing safety commitments and/or risk management; develops and recommends techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices.

Works to develop collegial relationships with sponsors, thought-leaders and clinical investigators.

Develops abstracts, provides podium presentations, and leads authorship of articles, manuscripts, etc. in industry and peer-reviewed journals to promote Company services.

Requirements:

*SME in Immunology Clinical Trials

Requires graduate degree in Epidemiology, Statistics, or Public Health; (Masters; Preferred Doctorate);

Requires in-depth knowledge of and experience with a variety of study designs; familiarity with post-marketing and late phase study designs as well as relevant guidelines preferred;

Requires basic knowledge of statistical programming language(s) (e.g., SAS, R, Python);

Excellent communication, presentation, both written and spoken;

Strong personal communication and team-oriented skills;

Demonstrated leadership and technical skills.

We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range:

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.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

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.