Talent.com
Syneos Health / inVentiv Health Commercial LLC is hiring : Principal Medical Write

Syneos Health / inVentiv Health Commercial LLC is hiring : Principal Medical Write

MediabistroVirginia, MN, United States
job_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Overview

Principal Medical Writer

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.

Responsibilities

  • Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately
  • Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision
  • Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings
  • Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides
  • Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately
  • Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format
  • Review statistical analysis plans and table / figure / listing specifications for appropriate content, grammar, format, and consistency, providing feedback to further define statistical output required and document needs
  • Interact and build good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables
  • Perform online clinical literature searches and comply with copyright requirements
  • Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staff
  • Mentor and lead less experienced medical writers on complex projects
  • Develop deep expertise on key topics in the industry and regulatory requirements
  • Work within budget specifications for assigned projects
  • Qualifications

  • Bachelor\'s degree in a relevant discipline with relevant writing experience; graduate degree preferred
  • 3-5 years of relevant experience in science, technical, or medical writing
  • Experience working in the biopharmaceutical, device, or contract research organization industry required
  • Strong understanding of FDA and ICH regulations, other regulatory guidelines, and / or good publication practices strongly required
  • Experience writing relevant document types required
  • Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style
  • Necessary Skills

  • Strong presentation, proofreading, collaborative, and interpersonal skills
  • Strong project and time management skills
  • Strong proficiency in MS Office
  • Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information
  • 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.

    #J-18808-Ljbffr

    serp_jobs.job_alerts.create_a_job

    Health • Virginia, MN, United States

    Job_description.internal_linking.related_jobs
    • serp_jobs.job_card.promoted
    Physician (MD / DO) - Surgery - Orthopedic - $350,000 to $400,000 per year in Virginia, MN

    Physician (MD / DO) - Surgery - Orthopedic - $350,000 to $400,000 per year in Virginia, MN

    LocumJobsOnlineVirginia, MN, US
    serp_jobs.job_card.full_time +2
    LocumJobsOnline is working with CompHealth to find a qualified Orthopedic Surgery MD in Virginia, Minnesota, 55792!.Come live and practice in the lake's region of northeastern Minnesota.Virginia is...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Care Coordinator, LSW

    Care Coordinator, LSW

    Bluestone Physician ServicesEmbarrass, MN, US
    serp_jobs.job_card.full_time
    Bluestone Physician Services delivers great outcomes by bringing exceptional care to patients living with complex, chronic conditions and disabilities. Our unique, robust model of care goes beyond p...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_hour
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Travel Nurse - RN - LD - Labor and Delivery - $2785.6 / Week

    Travel Nurse - RN - LD - Labor and Delivery - $2785.6 / Week

    Cynet HealthHibbing, MN, US
    serp_jobs.job_card.full_time
    Cynet Health is seeking an experienced Labor and Delivery Registered Nurse for an exciting Travel Nursing job in Hibbing, MN. Shift : 3x12 hr days Start Date : ASAP Duration : 13 weeks Pay : $2785.Ranke...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Travel Nurse RN - Labor / Delivery - $2,405 to $2,583 per week in Hibbing, MN

    Travel Nurse RN - Labor / Delivery - $2,405 to $2,583 per week in Hibbing, MN

    TravelNurseSourceHibbing, MN, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with Host Healthcare to find a qualified Labor / Delivery RN in Hibbing, Minnesota, 55746!.Host Healthcare is an award-winning travel healthcare company with an immediate...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Medical Device Sales – Paid Internship

    Medical Device Sales – Paid Internship

    Medical Sales CollegeEveleth, Minnesota, US
    serp_jobs.job_card.internship
    Description Medical Device Sales - Paid Internship Looking for a rewarding and lucrative career in the medical sales industry? Our paid Internship may be the right path for you! Here are just some ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Travel Nurse RN - Labor / Delivery - $2,244 to $2,487 per week in Hibbing, MN

    Travel Nurse RN - Labor / Delivery - $2,244 to $2,487 per week in Hibbing, MN

    TravelNurseSourceHibbing, MN, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with LRS Healthcare to find a qualified Labor / Delivery RN in Hibbing, Minnesota, 55746!.Ready to start your next travel adventure? LRS Healthcare offers a full benefits...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Locum Physician (MD / DO) - Obstetrics and Gynecology in Hibbing, MN

    Locum Physician (MD / DO) - Obstetrics and Gynecology in Hibbing, MN

    LocumJobsOnlineHibbing, MN, US
    serp_jobs.job_card.full_time +1
    LocumJobsOnline is working with Weatherby Healthcare to find a qualified Obstetrics and Gynecology MD in Hibbing, Minnesota, 55746!. Enjoy the locum tenens lifestyle knowing Weatherby is here to sup...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Travel Registered Nurse - Labor / Delivery - $2,451 per week in Hibbing, MN

    Travel Registered Nurse - Labor / Delivery - $2,451 per week in Hibbing, MN

    TravelNurseSourceHibbing, MN, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with GetMed Staffing to find a qualified Labor / Delivery RN in Hibbing, Minnesota, 55746!.GetMed Staffing is searching for a strong L&D RN to assist our traveler-fri...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Nurse RN - Labor / Delivery - $2,377 per week in Hibbing, MN

    Travel Nurse RN - Labor / Delivery - $2,377 per week in Hibbing, MN

    TravelNurseSourceHibbing, MN, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with Atlas MedStaff to find a qualified Labor / Delivery RN in Hibbing, Minnesota, 55746!.Atlas Medstaff is currently seeking candidates in the RN (L&D) profession fo...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Border Patrol Agent - Experienced (GL9 / GS11)

    Border Patrol Agent - Experienced (GL9 / GS11)

    U.S. Customs and Border ProtectionEveleth, MN, United States
    serp_jobs.job_card.full_time
    Check out these higher-salaried federal law enforcement opportunities with the U.Your current or prior law enforcement experience may qualify you for this career opportunity with the nation's premi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Travel Physical Therapist (PT) - $2,900 per week in Cook, MN

    Travel Physical Therapist (PT) - $2,900 per week in Cook, MN

    AlliedTravelCareersCook, MN, US
    serp_jobs.job_card.full_time
    AlliedTravelCareers is working with Cross Country Allied to find a qualified Physical Therapist (PT) in Cook, Minnesota, 55723!. As an inpatient physical therapist, you'll provide PT services to hel...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Border Patrol Agent

    Border Patrol Agent

    U.S. Customs and Border ProtectionGilbert, MN, United States
    serp_jobs.job_card.full_time
    Customs and Border Protection (CBP) offers those interested in a career in law enforcement an exceptional opportunity to work with an elite team of highly trained professionals whose camaraderie, p...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Travel Nurse RN - Labor / Delivery - $2,451 per week in Hibbing, MN

    Travel Nurse RN - Labor / Delivery - $2,451 per week in Hibbing, MN

    TravelNurseSourceHibbing, MN, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with GetMed Staffing to find a qualified Labor / Delivery RN in Hibbing, Minnesota, 55746!.GetMed Staffing is searching for a strong L&D RN to assist our traveler-fri...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Nurse RN - Labor / Delivery - $2,627 per week in Hibbing, MN

    Travel Nurse RN - Labor / Delivery - $2,627 per week in Hibbing, MN

    TravelNurseSourceHibbing, MN, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with PRN Healthcare to find a qualified Labor / Delivery RN in Hibbing, Minnesota, 55746!.Your adventure starts here with PRN Healthcare!. Take control of your career with...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    RN Case Manager

    RN Case Manager

    Procare HRGilbert, MN, US
    serp_jobs.job_card.part_time
    Start a new career as an RN Case Manager at Vitality Healthcare Management – providing In-Home Care Solutions! .Make a difference in someone's life every day.Vitality Healthcare Mana...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Family Medicine - OB Optional

    Family Medicine - OB Optional

    Essentia HealthHibbing, US
    serp_jobs.job_card.full_time
    The Essentia Primary Care Physician works as a leader of a Care Team.Utilizing Essentia Care Processes, the physician works collaboratively with other health care team members to achieve patient ca...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Telemedicine Physician

    Telemedicine Physician

    QuickMDVirginia, MN, US
    serp_jobs.job_card.full_time
    QuickMD is a leading telemedicine provider, delivering high-quality virtual care across 44 states.Since our founding in 2019, we have helped more than 100,000 patients access essential medical trea...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Travel Nurse RN - Labor / Delivery - $2,366 to $2,517 per week in Hibbing, MN

    Travel Nurse RN - Labor / Delivery - $2,366 to $2,517 per week in Hibbing, MN

    TravelNurseSourceHibbing, MN, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with Fusion Medical Staffing to find a qualified Labor / Delivery RN in Hibbing, Minnesota, 55746!. Facility in Hibbing, Minnesota.Fusion Medical Staffing is seeking a ski...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days