Talent.com
Principal Medical Writer
Principal Medical WriterSyneos Health/ inVentiv Health Commercial LLC • Nashville, TN, United States
serp_jobs.error_messages.no_longer_accepting
Principal Medical Writer

Principal Medical Writer

Syneos Health / inVentiv Health Commercial LLC • Nashville, TN, United States
job_description.job_card.30_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 • Nashville, TN, United States

    Job_description.internal_linking.related_jobs
    Sr Medical Writer Publications - Sponsor Dedicated - Remote Based

    Sr Medical Writer Publications - Sponsor Dedicated - Remote Based

    Syneos Health / inVentiv Health Commercial LLC • Nashville, TN, United States
    serp_jobs.job_card.full_time
    Sr Medical Writer Publications - Sponsor Dedicated - Remote Based.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We transl...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Locum Physician (MD / DO) - Gastroenterology in Tennessee

    Locum Physician (MD / DO) - Gastroenterology in Tennessee

    LocumJobsNetwork • All Cities, TN, US
    serp_jobs.job_card.full_time
    LocumJobsNetwork is working with Medicus Healthcare Solutions to find a qualified Gastroenterology MD in Tennessee!.Medicus is partnering with a hospital in Memphis, Tennessee, with an opening for ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Travel Medical-Surgical RN

    Travel Medical-Surgical RN

    Care Career • Hermitage, TN, US
    serp_jobs.job_card.full_time
    Care Career is seeking a travel nurse RN Med Surg for a travel nursing job in Hermitage, Tennessee.Job Description & Requirements. Pay package is based on 12 hour shifts and 36.Care Career bring...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

    American Medical Staffing • Hermitage, TN, US
    serp_jobs.job_card.full_time
    American Medical Staffing is seeking a travel nurse RN Med Surg for a travel nursing job in Hermitage, Tennessee.Job Description & Requirements. We’re living in the new normal.Lives and ca...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 • Nashville, TN, 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_30 • serp_jobs.job_card.promoted
    Locum Physician (MD / DO) - Emergency Medicine in Hendersonville, TN

    Locum Physician (MD / DO) - Emergency Medicine in Hendersonville, TN

    LocumJobsOnline • Hendersonville, TN, US
    serp_jobs.job_card.full_time
    LocumJobsOnline is working with Rhino Medical to find a qualified Emergency Medicine MD in Hendersonville, Tennessee, 37075!. Hendersonville, TN Emergency Medicine Physician Locum Tenens.Rhino Medic...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Travel Medical-Surgical RN

    Travel Medical-Surgical RN

    Triage Staffing • Hermitage, TN, US
    serp_jobs.job_card.full_time
    Triage Staffing is seeking a travel nurse RN Med Surg for a travel nursing job in Hermitage, Tennessee.Job Description & Requirements. Travel Nursing : Med / Surg Hermitage, TN.Location : ...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

    LRS Healthcare - Travel Nursing • Hermitage, TN, US
    serp_jobs.job_card.permanent
    LRS Healthcare - Travel Nursing is seeking a travel nurse RN Med Surg for a travel nursing job in Hermitage, Tennessee.Job Description & Requirements. LRS Healthcare - Travel Nursing Job ID #30-...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Nonclinical Writer

    Nonclinical Writer

    MMS • Nashville, TN, US
    serp_jobs.job_card.full_time
    serp_jobs.filters_job_card.quick_apply
    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 research ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30
    Travel Medical-Surgical RN

    Travel Medical-Surgical RN

    PRIDE Health • Hermitage, TN, US
    serp_jobs.job_card.full_time
    PRIDE Health is seeking a travel nurse RN Med Surg for a travel nursing job in Hermitage, Tennessee.Job Description & Requirements. Pay package is based on 12 hour shifts and 36.Posted job title...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

    Zack Group • Hermitage, TN, US
    serp_jobs.job_card.permanent
    Zack Group is seeking a travel nurse RN Med Surg for a travel nursing job in Hermitage, Tennessee.Job Description & Requirements. MS RN’s for positions in Hermitage, Tennessee.The ideal ca...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Locum Physician (MD / DO) - Emergency Medicine in Tennessee

    Locum Physician (MD / DO) - Emergency Medicine in Tennessee

    LocumJobsNetwork • All Cities, TN, US
    serp_jobs.job_card.full_time
    LocumJobsNetwork is working with LocumTenens.Emergency Medicine MD in Tennessee!.Job Reference Id : ORD-196240-MD-TN.Dates Needed : September - Ongoing. Shift Type : Day Shift; Night Shift.Board Cer...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Travel Medical-Surgical RN

    Travel Medical-Surgical RN

    GHR Healthcare - PH Division • Hermitage, TN, US
    serp_jobs.job_card.full_time
    GHR Healthcare - PH Division is seeking a travel nurse RN Med Surg for a travel nursing job in Hermitage, Tennessee.Job Description & Requirements. Med / Surg Registered Nurse (RN) Travel Jobs &nd...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Travel Medical-Surgical RN

    Travel Medical-Surgical RN

    Go Healthcare • Hermitage, TN, US
    serp_jobs.job_card.full_time
    Go Healthcare is seeking a travel nurse RN Med Surg for a travel nursing job in Hermitage, Tennessee.Job Description & Requirements. Pay package is based on 12 hour shifts and 36 hours per week ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Locum Physician (MD / DO) - Emergency Medicine in Tennessee

    Locum Physician (MD / DO) - Emergency Medicine in Tennessee

    LocumJobsOnline • All Cities, TN, US
    serp_jobs.job_card.full_time
    LocumJobsOnline is working with LocumTenens.Emergency Medicine MD in Tennessee!.Job Reference Id : ORD-196240-MD-TN.Dates Needed : September - Ongoing. Shift Type : Day Shift; Night Shift.Board Cert...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Travel Medical-Surgical RN

    Travel Medical-Surgical RN

    Medical Solutions • Hermitage, TN, US
    serp_jobs.job_card.full_time
    Medical Solutions is seeking a travel nurse RN Med Surg for a travel nursing job in Hermitage, Tennessee.Job Description & Requirements. We’re seeking talented healthcare professionals who...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

    Anders Group • Hermitage, TN, US
    serp_jobs.job_card.full_time
    Anders Group is seeking a travel nurse RN Med Surg for a travel nursing job in Hermitage, Tennessee.Job Description & Requirements. Pay package is based on 12 hour shifts and 36 hours per week (...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

    Genie Healthcare • Hermitage, TN, US
    serp_jobs.job_card.full_time
    Genie Healthcare is seeking a travel nurse RN Med Surg for a travel nursing job in Hermitage, Tennessee.Job Description & Requirements. Genie Healthcare is looking for a RN to work in MedSurg fo...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted