Talent.com
serp_jobs.error_messages.no_longer_accepting
Sr Medical Writer (Regulatory Documents)

Sr Medical Writer (Regulatory Documents)

Syneos Health / inVentiv Health Commercial LLCCharleston, SC, 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

Sr Medical Writer (Regulatory Documents)

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

  • 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.

    serp_jobs.job_alerts.create_a_job

    Medical Writer • Charleston, SC, United States

    Job_description.internal_linking.related_jobs
    • serp_jobs.job_card.promoted
    Medical Record Review Specialist

    Medical Record Review Specialist

    Roper StaffingMount Pleasant, SC, US
    serp_jobs.job_card.full_time
    Roper Staffing is seeking a detail-oriented Medical Records Specialist for the Mount Pleasant area.Schedule : M-F 8-5 primarily, but can be flexible for example- 9-6. Review medical records and relat...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Medical Assistant II

    Medical Assistant II

    Advanced Urology Institute LLCCharleston, SC, US
    serp_jobs.job_card.full_time
    The Medical Assistant II (MA II) supports the delivery of urological services, performs work as required and functions as an effective member of the interdisciplinary team.The Medical Assistant II ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Certified / Registered Medical Assistant

    Certified / Registered Medical Assistant

    Sweetgrass PediatricsSummerville, SC, US
    serp_jobs.job_card.full_time
    Assist medical providers in providing a high level of quality patient care.Performs a variety of duties in accordance with federal, state and local regulations along with established priorities and...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Medical Surgical RN

    Medical Surgical RN

    Summerville Medical CenterSummerville, SC, US
    serp_jobs.job_card.full_time +1
    Have you heard the great news?.We are currently offering Brand New RN Pay Rates with amazing benefits, a sign-on bonus and additional relocation assistance for qualified candidates.Apply today to l...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Certified Medical Asst / Med Tech-$2000 Sign on Bonus-Dorchester

    Certified Medical Asst / Med Tech-$2000 Sign on Bonus-Dorchester

    Genesys Health Alliance LLCSummerville, SC, US
    serp_jobs.job_card.full_time
    We are currently seeking a Full Time Certified Medical.Technician to join our team at Dorchester County Detention Center located in Summerville, South Carolina. GENESYS Health Alliance proudly manag...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Travel Medical-Surgical Float Pool RN

    Travel Medical-Surgical Float Pool RN

    Ethos Medical StaffingCharleston, SC, US
    serp_jobs.job_card.full_time
    Ethos Medical Staffing is seeking a travel nurse RN Float Med Surg for a travel nursing job in Charleston, South Carolina. Job Description & Requirements.Ethos Medical Staffing Job ID #34343298....serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Travel Medical-Surgical Float Pool RN - $1,674 per week

    Travel Medical-Surgical Float Pool RN - $1,674 per week

    PRIDE HealthCharleston, SC, United States
    serp_jobs.job_card.full_time
    PRIDE Health is seeking a travel nurse RN Float Med Surg for a travel nursing job in Charleston, South Carolina.Job Description & Requirements. Pay package is based on 12 hour shifts and 36.Posted j...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Medical-Surgical Float Pool RN - $1,714 per week

    Travel Medical-Surgical Float Pool RN - $1,714 per week

    GHR HealthcareCharleston, SC, United States
    serp_jobs.job_card.full_time
    GHR Healthcare is seeking a travel nurse RN Float Med Surg for a travel nursing job in Charleston, South Carolina.Job Description & Requirements. GHR Healthcare Job ID #73205420.Pay package is based...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Nonclinical Writer

    Nonclinical Writer

    MMSCharleston, SC, US
    serp_jobs.job_card.full_time
    Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical resea...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.new
    Technical Writer Job at Sev1Tech LLC in North Charleston

    Technical Writer Job at Sev1Tech LLC in North Charleston

    MediabistroNorth Charleston, SC, United States
    serp_jobs.job_card.full_time
    Sev1Tech is seeking a Technical Writer to support the Naval Information Warfare Center Atlantic (NIWC Atlantic) Expeditionary Enterprise Systems and Services (E2S2) Division.NIWC Atlantic provides ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Medical Materiel Specialist III (Lead)

    Medical Materiel Specialist III (Lead)

    Clearance JobsCharleston, SC, US
    serp_jobs.job_card.full_time
    Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect. As experts in healthcare IT experts, Apex is comm...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Travel Medical-Surgical Float Pool RN

    Travel Medical-Surgical Float Pool RN

    CrossMedCharleston, SC, US
    serp_jobs.job_card.full_time
    CrossMed is seeking a travel nurse RN Float Med Surg for a travel nursing job in Charleston, South Carolina.Job Description & Requirements. At CrossMed Healthcare Staffing, we aim to create last...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Technical Writer - Charleston, SC

    Technical Writer - Charleston, SC

    Cambridge International Systems IncCharleston, SC, US
    serp_jobs.job_card.full_time
    Technical Writer – Charleston, SC.Cambridge International Systems, Inc.Join a dynamic global team united by shared values : . At Cambridge, you’ll work alongside top talent worldwide, tack...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Medical-Surgical Float Pool RN

    Travel Medical-Surgical Float Pool RN

    Ardor Health SolutionsCharleston, SC, US
    serp_jobs.job_card.full_time
    Ardor Health Solutions is seeking a travel nurse RN Float Med Surg for a travel nursing job in Charleston, South Carolina. Job Description & Requirements.Ardor Health Solutions is looking for a ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Travel Medical-Surgical Float Pool RN

    Travel Medical-Surgical Float Pool RN

    Care Team SolutionsCharleston, SC, US
    serp_jobs.job_card.full_time
    Care Team Solutions is seeking a travel nurse RN Float Med Surg for a travel nursing job in Charleston, South Carolina.Job Description & Requirements. Registered Nurse must have 2+ years of rece...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Travel Medical-Surgical Float Pool RN - $1,518 per week

    Travel Medical-Surgical Float Pool RN - $1,518 per week

    CrossMedCharleston, SC, United States
    serp_jobs.job_card.full_time
    CrossMed is seeking a travel nurse RN Float Med Surg for a travel nursing job in Charleston, South Carolina.Job Description & Requirements. At CrossMed Healthcare Staffing, we aim to create lasting ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Travel Medical-Surgical Float Pool RN - $1,662 per week

    Travel Medical-Surgical Float Pool RN - $1,662 per week

    Ethos Medical StaffingCharleston, SC, United States
    serp_jobs.job_card.full_time
    Ethos Medical Staffing is seeking a travel nurse RN Float Med Surg for a travel nursing job in Charleston, South Carolina. Job Description & Requirements.Ethos Medical Staffing Job ID #34343298.Pay ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    MO-7 / 17 - 7513 - Technical Writer w / Medicaid Exp - Columbia, SC (Local to SC Candidates Only)

    MO-7 / 17 - 7513 - Technical Writer w / Medicaid Exp - Columbia, SC (Local to SC Candidates Only)

    FHRCharleston, SC, US
    serp_jobs.job_card.full_time
    serp_jobs.filters_job_card.quick_apply
    Hybrid (4 days in office in Columbia, SC, 1 day remote).Candidate must be a CURRENT South Carolina resident.Our direct client has an opening for a Technical Writer w / Medicaid Exp # 7513.This posit...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Certified Medical Assistant

    Certified Medical Assistant

    Saratoga Medical CenterGoose Creek, SC, US
    serp_jobs.job_card.full_time
    Saratoga Medical has an immediate opening for a Certified Medical Assistant (CMA) at Goose Creek Naval Base, SC.We offer a competitive salary, PTO, paid holidays, medical benefits and the wonderful...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Travel Medical-Surgical Float Pool RN - $1,591 per week

    Travel Medical-Surgical Float Pool RN - $1,591 per week

    GQR HealthcareCharleston, SC, United States
    serp_jobs.job_card.full_time
    GQR Healthcare is seeking a travel nurse RN Float Med Surg for a travel nursing job in Charleston, South Carolina.Job Description & Requirements. GQR Uniti Med is representing a well-known health sy...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30