Sr Medical Affairs Scientist

Incresearch (Buenos Aires, Argentina) Publicado hace 9 horas

Senior Medical Affairs Scientist


Come discover what our 25,000+ employees already know: work here matters everywhere. We’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 world. Because 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 themselves. Our 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 you. That’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 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.



SUMMARY:


Reviews and analyses project specific data and medical literature. Manages study-related committees such as Data Monitoring Committees (DMCs), Data Safety Monitoring Boards (DSMBs), and Adjudication Committees. Supports the preparation of budgets, Requests for Proposals (RFPs), and monitors financial budgets.



ESSENTIAL FUNCTIONS:




  1. Performs review of medical data listings, Case Report Form (CRF) line and lab listings, and medical coding; highlights areas for medical review.

  2. Performs analysis to identify trends within data, line, and lab listings.

  3. Performs initial assessments for Medical Affairs Pre-Enrollment Review process

  4. Assists Medical Monitor(s) with creation of Medical Management Plans

  5. Creates project plans related to Medical Data Review, Endpoint Management, and Pre-Enrollment Review

  6. Primary interface between Company and sponsors, vendors, and other departments in the area of DMC, DSMB, Safety Committee, and Adjudication Committee management. Provides specialized knowledge for international guidance regarding the conduct of study-related committees.

  7. Uploads and manages documents collected for pre-enrollment review and endpoint adjudication into TrialEASTM.

  8. Works with the Proposals department in the development of RFPs and proposals by providing budgets and text for projects.

  9. Supports operations of the Medical Affairs department by:



  • Identifying issues on the department’s operating budget and analyzing internal reports to track the budget throughout the fiscal year;

  • Researching historic budget information and utilizing it to initiate change orders when necessary or improving budgeting estimates;

  • Maintaining Standard Operating Procedures (SOPs) and participating in the review and improvement of other related SOPs.



  1. Provides senior level expertise and assists other Medical Affairs Scientist as needed.

  2. May have line management responsibilities for Medical Operations Coordinators and Medical Operations Specialists.






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 experience. MS in a Healthcare, Business Administration, Public Administration, Public Health, or equivalent degree preferred. Moderate clinical research experience and management experience. Experience in a Clinical Research Organization and related therapeutic specialties preferred. Knowledge of financial budgets and various financial analysis tools. Superior proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, MS Project), email, and internet. Strong presentation skills, interpersonal skills, as well as a team oriented approach. Excellent verbal, written, and communication skills. Ability to multitask under tight deadlines while providing attention to detail and high quality work. Ability to be flexible, adapt to change, work independently, as well as work in a matrix environment.




Disclaimer:



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.





For employees in the United States ONLY



FLSA status: Exempt



Years of experience required: Minimun of four (4) years of progressive clinical/medical affairs experience.



Physical Requirements: Position requires: ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. The noise level in the work environment is low.




Primary Location: Latin America - ARG-BuenosAires-Avda-del-Liber


Other Locations:


Job: Medical Affairs


Schedule: Full-time


Travel: Yes, 25 % of the Time


Employee Status: Regular


Sr Medical Affairs Scientist

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