Talent.com
Principal Medical Writer

Principal Medical Writer

Syneos Health / inVentiv Health Commercial LLCSioux Falls, SD, 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 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.

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 • Sioux Falls, SD, United States

    Job_description.internal_linking.related_jobs
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    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 LLCSioux Falls, SD, 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_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Locum Physician Assistant (PA) - Emergency Medicine - $75 to $121 per hour in Canton, SD

    Locum Physician Assistant (PA) - Emergency Medicine - $75 to $121 per hour in Canton, SD

    LocumJobsNetworkCanton, SD, US
    serp_jobs.job_card.full_time +1
    LocumJobsNetwork is working with CompHealth to find a qualified Emergency Medicine PA in Canton, South Dakota, 57013!.Some locum assignments can be as short as a day, others, years.Some are far fro...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Locum Nurse Practitioner (NP) - Family Practice - $70 to $90 per hour in Canton, SD

    Locum Nurse Practitioner (NP) - Family Practice - $70 to $90 per hour in Canton, SD

    LocumJobsNetworkCanton, SD, US
    serp_jobs.job_card.full_time
    LocumJobsNetwork is working with Weatherby Healthcare to find a qualified Family Practice NP in Canton, South Dakota, 57013!. If this opportunity sounds right for you, give us a call today to speak ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Senior Principal Medical Writer

    Senior Principal Medical Writer

    Syneos Health / inVentiv Health Commercial LLCSioux Falls, SD, United States
    serp_jobs.job_card.full_time
    Senior Principal Medical Writer.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affai...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Sr Medical Writer (Regulatory Documents)

    Sr Medical Writer (Regulatory Documents)

    Syneos Health / inVentiv Health Commercial LLCSioux Falls, SD, United States
    serp_jobs.job_card.full_time
    Sr Medical Writer (Regulatory Documents).Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Locum Nurse Practitioner (NP) - Emergency Medicine - $75 to $121 per hour in Canton, SD

    Locum Nurse Practitioner (NP) - Emergency Medicine - $75 to $121 per hour in Canton, SD

    LocumJobsOnlineCanton, SD, US
    serp_jobs.job_card.full_time +1
    LocumJobsOnline is working with CompHealth to find a qualified Emergency Medicine NP in Canton, South Dakota, 57013!.When it comes to finding the perfect locums assignment, sometimes it is all abou...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Nurse - RN - LTC - Long Term Care - $1796 / Week

    Travel Nurse - RN - LTC - Long Term Care - $1796 / Week

    Coast Medical ServiceFlandreau, SD, US
    serp_jobs.job_card.full_time
    Coast Medical Service is seeking an experienced Long Term Care Registered Nurse for an exciting Travel Nursing job in Flandreau, SD. Shift : 5x8 hr days Start Date : 10 / 13 / 2025 Duration : 8 weeks Pay : ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Nurse - Registered Nurse - LTC - Long Term Care - $1699 / Week

    Travel Nurse - Registered Nurse - LTC - Long Term Care - $1699 / Week

    Fusion Medical StaffingFlandreau, SD, US
    serp_jobs.job_card.full_time
    Fusion Medical Staffing is seeking an experienced Long Term Care Registered Nurse for an exciting Travel Nursing job in Flandreau, SD. Shift : Inquire Start Date : 10 / 13 / 2025 Duration : 8 weeks Pay : $1...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Principal / Sr Medical Writer - Publications - Sponsor Dedicated - US (Central Location)

    Principal / Sr Medical Writer - Publications - Sponsor Dedicated - US (Central Location)

    Syneos Health / inVentiv Health Commercial LLCSioux Falls, SD, United States
    serp_jobs.job_card.full_time
    Principal / Sr Medical Writer - Publications - Sponsor Dedicated - US (Central Location).Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate cust...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Locum Nurse Practitioner (NP) - Emergency Medicine - $75 to $121 per hour in Canton, SD

    Locum Nurse Practitioner (NP) - Emergency Medicine - $75 to $121 per hour in Canton, SD

    LocumJobsNetworkCanton, SD, US
    serp_jobs.job_card.full_time +1
    LocumJobsNetwork is working with CompHealth to find a qualified Emergency Medicine NP in Canton, South Dakota, 57013!.When it comes to finding the perfect locums assignment, sometimes it is all abo...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Locum Physician (MD / DO) - Family Practice in Pipestone, MN

    Locum Physician (MD / DO) - Family Practice in Pipestone, MN

    LocumJobsNetworkPipestone, MN, US
    serp_jobs.job_card.full_time +1
    LocumJobsNetwork is working with CompHealth to find a qualified Family Practice MD in Pipestone, Minnesota, 56164!.Though your CompHealth recruiter will be your single point of contact, they are ba...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Locum Physician Assistant (PA) - Family Practice - $70 to $90 per hour in Canton, SD

    Locum Physician Assistant (PA) - Family Practice - $70 to $90 per hour in Canton, SD

    LocumJobsNetworkCanton, SD, US
    serp_jobs.job_card.full_time
    LocumJobsNetwork is working with Weatherby Healthcare to find a qualified Family Practice PA in Canton, South Dakota, 57013!. Weatherby can help you build a custom career plan, with multiple positio...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Nurse - RN - LTC - Long Term Care - $1796 / Week - Hiring Now

    Travel Nurse - RN - LTC - Long Term Care - $1796 / Week - Hiring Now

    Coast Medical ServiceFlandreau, SD, US
    serp_jobs.job_card.full_time
    Coast Medical Service is seeking an experienced Long Term Care Registered Nurse for an exciting Travel Nursing job in Flandreau, SD. Shift : 5x8 hr days Start Date : 10 / 13 / 2025 Duration : 8 weeks Pay : ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Nurse - LPN - LTC - Long Term Care - $1285.92 / Week

    Travel Nurse - LPN - LTC - Long Term Care - $1285.92 / Week

    CrossMed HealthcarePipestone, MN, US
    serp_jobs.job_card.full_time
    CrossMed Healthcare is seeking an experienced Long Term Care Licensed Practical Nurse for an exciting Travel Nursing job in Pipestone, MN. Shift : Inquire Start Date : 10 / 06 / 2025 Duration : 13 weeks Pa...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.new
    Senior Principal Medical Writer

    Senior Principal Medical Writer

    MediabistroSioux Falls, SD, United States
    serp_jobs.job_card.full_time
    Senior Principal Medical WriterSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affair...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Travel Nurse - RN - LTC - Long Term Care - $1699 / Week

    Travel Nurse - RN - LTC - Long Term Care - $1699 / Week

    Fusion Medical StaffingFlandreau, SD, US
    serp_jobs.job_card.full_time
    Fusion Medical Staffing is seeking an experienced Long Term Care Registered Nurse for an exciting Travel Nursing job in Flandreau, SD. Shift : Inquire Start Date : 10 / 13 / 2025 Duration : 8 weeks Pay : $1...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Nurse - LPN - LTC - Long Term Care

    Travel Nurse - LPN - LTC - Long Term Care

    CrossMed HealthcarePipestone, MN, US
    serp_jobs.job_card.full_time
    CrossMed Healthcare is seeking an experienced Long Term Care Licensed Practical Nurse for an exciting Travel Nursing job in Pipestone, MN. Shift : Inquire Start Date : ASAP Duration : 13 weeks.At Cross...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Locum Physician (MD / DO) - Family Practice in Pipestone, MN

    Locum Physician (MD / DO) - Family Practice in Pipestone, MN

    LocumJobsOnlinePipestone, MN, US
    serp_jobs.job_card.full_time +1
    LocumJobsOnline is working with CompHealth to find a qualified Family Practice MD in Pipestone, Minnesota, 56164!.Though your CompHealth recruiter will be your single point of contact, they are bac...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30