Talent.com
Principal Medical Writer Job at Syneos Health/ inVentiv Health Commercial LLC in
Principal Medical Writer Job at Syneos Health/ inVentiv Health Commercial LLC inMediabistro • Wichita, KS, United States
Principal Medical Writer Job at Syneos Health / inVentiv Health Commercial LLC in

Principal Medical Writer Job at Syneos Health / inVentiv Health Commercial LLC in

Mediabistro • Wichita, KS, 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

Principal Medical WriterSyneos 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 EVERYWHEREWhy 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

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 projectsQualifications :
  • 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 StyleNecessary 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 informationGet to know Syneos HealthOver 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.Additional InformationTasks, 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.
  • serp_jobs.job_alerts.create_a_job

    Medical Writer • Wichita, KS, United States

    Job_description.internal_linking.related_jobs
    Local Contract Travel Medical / Surgical RN

    Local Contract Travel Medical / Surgical RN

    Host Healthcare • Wichita, KS, US
    serp_jobs.job_card.full_time
    Host Healthcare is seeking a local contract nurse RN Med Surg for a local contract nursing job in Wichita, Kansas.Job Description & Requirements. Pay package is based on 12 hour shifts and 36 ho...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Travel Nurse RN - Labor & Delivery - $2,066 to $2,266 per week in Winfield, KS

    Travel Nurse RN - Labor & Delivery - $2,066 to $2,266 per week in Winfield, KS

    TravelNurseSource • Winfield, KS, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with Ventura MedStaff to find a qualified Labor / Delivery RN in Winfield, Kansas, 67156!.Are you ready to take your Travel career to the next level? See places you have...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Principal Medical Writer

    Principal Medical Writer

    Syneos Health / inVentiv Health Commercial LLC • Wichita, KS, United States
    serp_jobs.job_card.full_time
    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 ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Sr Principal / Principal Medical Writer - East Coast Preferred - Single Sponsor

    Sr Principal / Principal Medical Writer - East Coast Preferred - Single Sponsor

    Syneos Health / inVentiv Health Commercial LLC • Wichita, KS, US
    serp_jobs.job_card.full_time
    Sr Principal / Principal Medical Writer (Publication Strategy / Planning) - East Coast Preferred - Single SponsorSyneos Health is a leading fully integrated biopharmaceutical solutions organization b...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel Nurse RN - Labor & Delivery - $2,017 to $2,317 per week in Winfield, KS

    Travel Nurse RN - Labor & Delivery - $2,017 to $2,317 per week in Winfield, KS

    TravelNurseSource • Winfield, KS, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with Wayward Medical Staffing to find a qualified Labor / Delivery RN in Winfield, Kansas, 67156!. Core Mandatory Part II (Nursing).Wayward RN General Job Description.Abou...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel Nurse RN - Labor & Delivery - $2,435 per week in Winfield, KS

    Travel Nurse RN - Labor & Delivery - $2,435 per week in Winfield, KS

    TravelNurseSource • Winfield, KS, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with talent4health to find a qualified Labor / Delivery RN in Winfield, Kansas, 67156!.Assists in the care of pregnant women and newborns during labor, delivery, and post...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Syneos Health / inVentiv Health Commercial LLC • Wichita, KS, United States
    serp_jobs.job_card.full_time
    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel Medical / Surgical RN

    Travel Medical / Surgical RN

    Ardor Health Solutions • Wichita, KS, US
    serp_jobs.job_card.full_time
    Ardor Health Solutions is seeking a travel nurse RN Med Surg for a travel nursing job in Wichita, Kansas.Job Description & Requirements. Ardor Health Solutions is looking for a Medical Surgical ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Principal Medical Publications Writer

    Principal Medical Publications Writer

    VirtualVocations • Wichita, Kansas, United States
    serp_jobs.job_card.full_time
    A company is looking for a Principal Medical Publications Writer to lead the preparation and development of high-quality medical publications and documents. Key Responsibilities Serve as a subject...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Principal Medical Writer

    Principal Medical Writer

    Mediabistro • Wichita, KS, United States
    serp_jobs.job_card.full_time
    Principal Medical WriterSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and c...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days
    Travel Nurse RN - Labor & Delivery - $3,446 per week in Winfield, KS

    Travel Nurse RN - Labor & Delivery - $3,446 per week in Winfield, KS

    TravelNurseSource • WINFIELD, KS, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with Gifted Healthcare to find a qualified Labor / Delivery RN in WINFIELD, Kansas, 67156!.The Gifted Healthcare Experience . Gifted Healthcare is an award-winning travel ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Sr Principal / Principal Medical Writer (Publication Strategy / Planning) - East Coast Preferred - Single Sponsor

    Sr Principal / Principal Medical Writer (Publication Strategy / Planning) - East Coast Preferred - Single Sponsor

    Syneos Health / inVentiv Health Commercial LLC • Wichita, KS, United States
    serp_jobs.job_card.full_time
    Sr Principal / Principal Medical Writer (Publication Strategy / Planning) - East Coast Preferred - Single Sponsor.Syneos Health is a leading fully integrated biopharmaceutical solutions organization ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Sr Principal / Principal Medical Writer - East Coast Preferred - Single Sponsor

    Sr Principal / Principal Medical Writer - East Coast Preferred - Single Sponsor

    Mediabistro • Wichita, KS, United States
    serp_jobs.job_card.full_time
    Sr Principal / Principal Medical Writer (Publication Strategy / Planning) - East Coast Preferred - Single SponsorSyneos Health is a leading fully integrated biopharmaceutical solutions organization b...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days
    Travel Nurse RN - Labor & Delivery - $2,110 per week in Winfield, KS

    Travel Nurse RN - Labor & Delivery - $2,110 per week in Winfield, KS

    TravelNurseSource • Winfield, KS, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with GetMed Staffing to find a qualified Labor / Delivery RN in Winfield, Kansas, 67156!.GetMed Staffing is searching for a strong L&D RN to assist our traveler-frien...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Expert Research Writer

    Expert Research Writer

    VirtualVocations • Wichita, Kansas, United States
    serp_jobs.job_card.full_time
    A company is looking for an Expert Research Writer & Strategist.Key Responsibilities Develop and produce white papers, articles, and case studies on relevant healthcare topics Create speeches, p...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Senior Medical Writer

    Senior Medical Writer

    VirtualVocations • Wichita, Kansas, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Medical Writer (Project-Based) - Remote.Key Responsibilities Critically evaluate and interpret medical literature for study design and scientific rigor Write an...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Service Writer Job at Fleetpride in Wichita

    Service Writer Job at Fleetpride in Wichita

    Mediabistro • Wichita, KS, United States
    serp_jobs.job_card.full_time
    FleetPride is the largest after-market distributor of heavy-duty truck and trailer parts in the U.Partner with the best in the heavy-duty industry and apply today!The Service Writer communicates es...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days
    Travel Medical / Surgical RN

    Travel Medical / Surgical RN

    Host Healthcare • Wichita, KS, US
    serp_jobs.job_card.full_time
    Host Healthcare is seeking a travel nurse RN Med Surg for a travel nursing job in Wichita, Kansas.Job Description & Requirements. Pay package is based on 12 hour shifts and 36 hours per week (su...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted