Job details
Job type full-time
Full job description
Medical affairs scientist - (21009915) description
Medical affairs scientist
Come discover what our 25,000+ employees already know: work here matters everywhereWe’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the syneos health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the worldBecause to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
Why syneos health
#syneoshealthlife means we’re committed to our total self culture – where everyone can authentically be themselvesOur total self culture is what unites us globally, and we know every person’s unique contributions make a difference.
We believe our success is a direct result of the people who are driving it – you! we value your dedication to care for our customers and patients, so we want to focus on taking care of youThat’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
We are continuously building the company we all want to work for and our customers want to work withWhy? 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.
Summary:
Reviews and analyses project specific data and medical literatureManages study-related committees such as data monitoring committees (dmcs), data safety monitoring boards (dsmbs), and adjudication committees.
Essential functions:
1Performs review of medical data listings, case report form (crf) line and lab listings, and medical coding; highlights areas for medical review.
2Performs analysis to identify trends within data, line, and lab listings.
3Performs initial assessments for medical affairs pre-enrollment review process.
4Assists medical monitor(s) with creation of medical management plans.
5Creates project plans related to medical data review, endpoint management, and pre-enrollment review.
6Primary interface between company and sponsors, vendors, and other departments in the area of dmc, dsmb, safety committee and adjudication committee managementProvides specialized knowledge for international guidance regarding the conduct of study-related committees.
7Uploads and manages documents collected for pre-enrollment review and endpoint adjudication into trialeastm.
Other responsibilities:
Performs other work related duties as assignedMinimal travel may be required (up to 25%); post covid
Qualifications
Requirements:
Ba/bs in the biological sciences or related discipline in the natural sciences/health care field, nursing degree, or equivalent combination of education and experienceMs in a healthcare, business administration, public administration, public health, or equivalent degree preferredMinimum of two (2) years progressive clinical / medical affairs experienceExperience in a clinical research organization and related therapeutic specialties preferredKnowledge of financial budgets and various financial analysis toolsSuperior proficiency in microsoft office suite (word, excel, powerpoint, ms project), email, and internetStrong presentation skills, interpersonal skills, as well as a team oriented approachExcellent verbal, written, and communication skillsAbility to multitask under tight deadlines while providing attention to detail and high quality workAbility to be flexible, adapt to change, work independently, as well as work in a matrix environment.
As a healthcare company we have an important responsibility to protect individual and public healthThis position will require individuals to be fully vaccinated against covid-19 as part of their job responsibilities, unless an exemption can be confirmed based on a medical condition or sincerely held religious beliefSubmission & approval of an exemption does not guarantee that an exemption can be accommodated.
This job excludes co applicants
Disclaimer:
Tasks, duties, and responsibilities as listed in this job description are not exhaustiveThe company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilitiesEquivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the job descriptionThe company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described aboveFurther, nothing contained herein should be construed to create an employment contractOccasionally, required skills/experiences for jobs are expressed in brief termsAny 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.
Primary location: north america - us home-based
Job: medical affairs
Schedule: full-time
Travel: yes, 25 % of the time
Employee status: regular