Talent.com
Sr Medical Writer (Regulatory Documents)

Sr Medical Writer (Regulatory Documents)

Syneos Health / inVentiv Health Commercial LLCPlano, TX, United States
9 days ago
Job type
  • Full-time
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.

    Create a job alert for this search

    Medical Writer • Plano, TX, United States

    Related jobs
    • Promoted
    Travel Medical Assistant (MA) - $731 to $762 per week in Denton, TX

    Travel Medical Assistant (MA) - $731 to $762 per week in Denton, TX

    AlliedTravelCareersDenton, TX, US
    Full-time
    AlliedTravelCareers is working with Greenstaff Medical to find a qualified Medical Assistant in Denton, Texas, 76201!.Certified Medical Assistant (CMA). Why Choose Greenstaff Medical US?.Your Truste...Show moreLast updated: 13 days ago
    • Promoted
    Travel Nurse - RN - ER - Emergency Room - $1562.4 / Week - Hiring Now

    Travel Nurse - RN - ER - Emergency Room - $1562.4 / Week - Hiring Now

    CrossMed HealthcareKaufman, TX, US
    Full-time
    CrossMed Healthcare is seeking an experienced Emergency Room Registered Nurse for an exciting Travel Nursing job in Kaufman, TX. Shift : Inquire Start Date : ASAP Duration : 13 weeks Pay : $1562.At Cros...Show moreLast updated: 1 day ago
    • Promoted
    Travel Echo Tech - $2,394 to $2,497 per week in Denton, TX

    Travel Echo Tech - $2,394 to $2,497 per week in Denton, TX

    AlliedTravelCareersDenton, TX, US
    Full-time
    AlliedTravelCareers is working with Greenstaff Medical to find a qualified Echo Tech in Denton, Texas, 76201!.Why Choose Greenstaff Medical US?. Your Trusted Partner in Healthcare Staffing.At Greens...Show moreLast updated: 30+ days ago
    • Promoted
    Principal / Senior Medical Writer - Regulatory - Oncology - North America / United Kingdom and Ireland (homebased)

    Principal / Senior Medical Writer - Regulatory - Oncology - North America / United Kingdom and Ireland (homebased)

    Syneos Health / inVentiv Health Commercial LLCPlano, TX, United States
    Full-time
    Principal / Senior Medical Writer - Regulatory - Oncology - North America / United Kingdom and Ireland (homebased).Syneos Health is a leading fully integrated biopharmaceutical solutions organization b...Show moreLast updated: 6 days ago
    • Promoted
    • New!
    Travel Nurse RN - Labor & Delivery - $2,276 to $2,329 per week in Collin, TX

    Travel Nurse RN - Labor & Delivery - $2,276 to $2,329 per week in Collin, TX

    TravelNurseSourceCollin, TX, US
    Full-time
    TravelNurseSource is working with MUVE Healthcare LLC to find a qualified Labor / Delivery RN in Collin, Texas, 75033!.Join our team for an exciting travel nursing opportunity!.As a member of the int...Show moreLast updated: less than 1 hour ago
    • Promoted
    Travel CT Tech - $2,394 to $2,497 per week in Kaufman, TX

    Travel CT Tech - $2,394 to $2,497 per week in Kaufman, TX

    AlliedTravelCareersKaufman, TX, US
    Full-time
    AlliedTravelCareers is working with Greenstaff Medical to find a qualified CT Tech in Kaufman, Texas, 75142!.Computed Tomography Technologist (CT). Why Choose Greenstaff Medical US?.Your Trusted Par...Show moreLast updated: 30+ days ago
    • Promoted
    Travel MRI Tech - $33 to $42 per hour in Mckinney, TX

    Travel MRI Tech - $33 to $42 per hour in Mckinney, TX

    AlliedTravelCareersMckinney, TX, US
    Full-time
    AlliedTravelCareers is working with Health Saviours to find a qualified MRI Tech in Mckinney, Texas, 75069!.Position : MRI Tech – Full Time. Shifts : 12 hrs FT Nights Thurs-Sat 7 : 00 PM-7 : 30 AM.Max Pay...Show moreLast updated: 2 days ago
    • Promoted
    Principal Medical Writer

    Principal Medical Writer

    Syneos Health / inVentiv Health Commercial LLCPlano, TX, United States
    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 ...Show moreLast updated: 30+ days ago
    • Promoted
    Travel Interventional Radiology (IR) - $2,426 per week in Kaufman, TX

    Travel Interventional Radiology (IR) - $2,426 per week in Kaufman, TX

    AlliedTravelCareersKaufman, TX, US
    Full-time
    AlliedTravelCareers is working with Skyline Med Staff to find a qualified Interventional Radiology in Kaufman, Texas, 75142!. Join the Top- Rated Travel Healthcare Team! Skyline Med Staff was named...Show moreLast updated: 12 days ago
    • Promoted
    Senior Principal Medical Writer

    Senior Principal Medical Writer

    VirtualVocationsPlano, Texas, United States
    Full-time
    A company is looking for a Senior Principal Medical Writer to lead the development of clinical and regulatory documents.Key Responsibilities Develop and author clinical and regulatory documents, ...Show moreLast updated: 1 day ago
    • Promoted
    Certified Medical Assistant II

    Certified Medical Assistant II

    Baylor Scott & White HealthMcKinney, TX, US
    Full-time
    W University Dr, Suite 100, McKinney, 75071.Schedule - Monday thru Friday 8am - 500pm.The Certified Medical Assistant 2, under the direction of a physician, assists in the delivery of health care f...Show moreLast updated: 30+ days ago
    • Promoted
    Travel Cardiovascular Surgery RN - $1,986 per week

    Travel Cardiovascular Surgery RN - $1,986 per week

    American Medical StaffingDenton, TX, United States
    Full-time
    American Medical Staffing is seeking a travel nurse RN CVOR for a travel nursing job in Denton, Texas.Job Description & Requirements. We’re living in the new normal.Lives and careers look different ...Show moreLast updated: 15 days ago
    • Promoted
    Senior Medical Writer

    Senior Medical Writer

    VirtualVocationsPlano, Texas, United States
    Full-time
    A company is looking for a Senior Specialist, Medical Writing.Key Responsibilities Support the development of regulatory and clinical documents for products across the Transcatheter Mitral and Tr...Show moreLast updated: 30+ days ago
    • Promoted
    Travel Emergency Department Registered Nurse - $1,564 per week

    Travel Emergency Department Registered Nurse - $1,564 per week

    TRS HealthcareKaufman, TX, United States
    Full-time
    TRS Healthcare is seeking a travel nurse RN ED - Emergency Department for a travel nursing job in Kaufman, Texas.Job Description & Requirements. TRS Healthcare Job ID #13708970.Pay package is based ...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Travel Nurse RN - Emergency Room (ER) / Trauma - $1,764 to $1,840 per week in Kaufman, TX

    Travel Nurse RN - Emergency Room (ER) / Trauma - $1,764 to $1,840 per week in Kaufman, TX

    TravelNurseSourceKaufman, TX, US
    Full-time
    TravelNurseSource is working with Greenstaff Medical to find a qualified ER / Trauma RN in Kaufman, Texas, 75142!.Why Choose Greenstaff Medical US?. Your Trusted Partner in Healthcare Staffing.At Gree...Show moreLast updated: less than 1 hour ago
    • Promoted
    Travel Surgical Tech - $2,520 to $2,628 per week in Rockwall, TX

    Travel Surgical Tech - $2,520 to $2,628 per week in Rockwall, TX

    AlliedTravelCareersRockwall, TX, US
    Full-time
    AlliedTravelCareers is working with Greenstaff Medical to find a qualified Surg Tech in Rockwall, Texas, 75032!.Why Choose Greenstaff Medical US?. Your Trusted Partner in Healthcare Staffing.At Gree...Show moreLast updated: 13 days ago
    • Promoted
    Travel Medical Assistant (MA) - $882 to $920 per week in Denton, TX

    Travel Medical Assistant (MA) - $882 to $920 per week in Denton, TX

    AlliedTravelCareersDenton, TX, US
    Full-time
    AlliedTravelCareers is working with Greenstaff Medical to find a qualified Medical Assistant in Denton, Texas, 76201!.Certified Medical Assistant (CMA). Why Choose Greenstaff Medical US?.Your Truste...Show moreLast updated: 7 days ago
    • Promoted
    Medical Writer

    Medical Writer

    VirtualVocationsGarland, Texas, United States
    Full-time
    A company is looking for a Medical Writer, encouraging recent PhD / PharmD candidates to apply.Key Responsibilities Produce high-quality content for various medical communications projects, demonst...Show moreLast updated: 30+ days ago