Talent.com
Sr Medical Writer (Regulatory Documents)

Sr Medical Writer (Regulatory Documents)

Syneos Health / inVentiv Health Commercial LLCAlbuquerque, NM, 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 • Albuquerque, NM, United States

    Job_description.internal_linking.related_jobs
    • serp_jobs.job_card.promoted
    Medical Writer

    Medical Writer

    VirtualVocationsAlbuquerque, New Mexico, United States
    serp_jobs.job_card.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...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • 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 LLCAlbuquerque, NM, 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_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Locum Physician (MD / DO) - Urology in New Mexico

    Locum Physician (MD / DO) - Urology in New Mexico

    LocumJobsOnlineRio Rancho, New Mexico, US
    serp_jobs.job_card.full_time +2
    LocumJobsOnline is working with Weatherby Healthcare to find a qualified Urology MD in New Mexico!.Get in touch with a Weatherby consultant today to learn more about this and other opportunities av...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    RN - OUTPATIENT

    RN - OUTPATIENT

    University of New Mexico - HospitalsTijeras, NM, US
    serp_jobs.job_card.full_time
    Relocation Assistance Available.Receive 17% Weekday Nights, 26% Weekend Nights and 15% Weekend Day shift differentials.Compensation for this role is based on a number of factors, including but not ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Senior Principal Medical Writer

    Senior Principal Medical Writer

    VirtualVocationsAlbuquerque, New Mexico, United States
    serp_jobs.job_card.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, ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.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 LLCAlbuquerque, NM, United States
    serp_jobs.job_card.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...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Mixed Animal Veterinarian

    Mixed Animal Veterinarian

    Los Lunas Animal ClinicLos Lunas, NM, US
    serp_jobs.job_card.full_time
    Join Our Team as an Associate Veterinarian!.Our passionate team offers a comprehensive range of services, from routine wellness exams and vaccinations to advanced diagnostics and surgical procedure...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    PARAMEDIC - RAPID RESPONSE

    PARAMEDIC - RAPID RESPONSE

    University of New Mexico - HospitalsSandia Park, NM, US
    serp_jobs.job_card.full_time
    Receive 17% Weekday Nights, 26% Weekend Nights and 15% Weekend Day shift differentials.Compensation for this role is based on a number of factors, including but not limited to experience, education...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Locum Physician (MD / DO) in New Mexico

    Locum Physician (MD / DO) in New Mexico

    LocumJobsOnlineRio Rancho, New Mexico, US
    serp_jobs.job_card.full_time +2
    LocumJobsOnline is working with Barton Associates to find a qualified Other MD in New Mexico!.We are looking for a Nuclear Medicine Physician to fill a locum tenens role in New Mexico, offering a 1...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Locum Physician (MD / DO) - Emergency Medicine in Raton, NM

    Locum Physician (MD / DO) - Emergency Medicine in Raton, NM

    LocumJobsOnlineRio Rancho, New Mexico, US
    serp_jobs.job_card.full_time +1
    LocumJobsOnline is working with Aya Locums to find a qualified Emergency Medicine MD in Raton, New Mexico, 87740!.Aya Locums has an immediate opening for a locum Emergency Medicine job in Raton, NM...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    GENERAL RADIOLOGY TECHNOLOGIST

    GENERAL RADIOLOGY TECHNOLOGIST

    University of New Mexico - HospitalsAlgodones, NM, US
    serp_jobs.job_card.part_time
    Receive 17% Weekday Nights, 26% Weekend Nights and 15% Weekend Day shift differentials.Compensation for this role is based on a number of factors, including but not limited to experience, education...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Senior Medical Writer

    Senior Medical Writer

    VirtualVocationsAlbuquerque, New Mexico, United States
    serp_jobs.job_card.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...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.new
    Gilead Sciences, Inc. is hiring : Senior Manager, Medical Writing, Oncology in Al

    Gilead Sciences, Inc. is hiring : Senior Manager, Medical Writing, Oncology in Al

    MediabistroAlbuquerque, NM, United States
    serp_jobs.job_card.full_time +1
    Senior Manager, Medical Writing, Oncology.Senior Manager, Medical Writing, Oncology.United States – Remote Regulatory Regular. At Gilead, we’re creating a healthier world for all people.For more tha...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    PARAMEDIC ER

    PARAMEDIC ER

    University of New Mexico - HospitalsSandia Park, NM, US
    serp_jobs.job_card.full_time
    Relocation Assistance Available.Receive 17% Weekday Nights, 26% Weekend Nights and 15% Weekend Day shift differentials.Compensation for this role is based on a number of factors, including but not ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    APRN INPATIENT

    APRN INPATIENT

    University of New Mexico - HospitalsCedar Crest, NM, US
    serp_jobs.job_card.full_time
    Relocation Assistance Available.Compensation for this role is based on a number of factors, including but not limited to experience, education, and other business and organizational considerations....serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Locum Physician (MD / DO) - Emergency Medicine in New Mexico

    Locum Physician (MD / DO) - Emergency Medicine in New Mexico

    LocumJobsOnlineRio Rancho, New Mexico, US
    serp_jobs.job_card.full_time +1
    LocumJobsOnline is working with Weatherby Healthcare to find a qualified Emergency Medicine MD in New Mexico!.Get in touch with a Weatherby consultant today to learn more about this and other oppor...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    REGISTRATION & ELIGIBILITY SPECIALIST

    REGISTRATION & ELIGIBILITY SPECIALIST

    University of New Mexico - HospitalsTome, NM, US
    serp_jobs.job_card.full_time
    Compensation for this role is based on a number of factors, including but not limited to experience, education, and other business and organizational considerations. Perform pre-registration and reg...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • 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 LLCAlbuquerque, NM, 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_days