Talent.com
Sr Medical Writer - Medical Device + Regulatory Documents - Remote Based
Sr Medical Writer - Medical Device + Regulatory Documents - Remote BasedSyneos Health/ inVentiv Health Commercial LLC • Washington, DC, United States
Sr Medical Writer - Medical Device + Regulatory Documents - Remote Based

Sr Medical Writer - Medical Device + Regulatory Documents - Remote Based

Syneos Health / inVentiv Health Commercial LLC • Washington, DC, United States
job_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
  • serp_jobs.filters.remote
job_description.job_card.job_description

Sr Medical Writer - Medical Device + Regulatory Documents - Remote Based

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

  • Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. Leads the resolution of comments from the client.
  • Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; 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.
  • Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and / or client approved-templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget.
  • Coordinates quality and editorial reviews. Ensures source documentation is managed appropriately. Leads team document reviews, and reviews documents as needed.
  • Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format.
  • Reviews statistical analysis plans and table / figure / listing specifications for appropriate content, and for grammar, format, and consistency. Provides feedback to further define statistical output required and document needs.
  • Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables.
  • Performs online clinical literature searches and complies with copyright requirements.
  • Identifies and proposes solutions to resolve issues, escalating as appropriate. Provides technical support, training, and consultation to department and other company staff. May contribute to development of internal materials and presentations or changes to internal process, standard practices, and capabilities.
  • Mentors and leads less experienced medical writers on complex projects, as necessary.
  • Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing.
  • Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership.
  • Completes required administrative tasks within the specified timeframes.
  • Performs other work-related duties as assigned.
  • Minimal travel may be required (less than 25%).
  • At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions / bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

    Salary Range :

    $80,600.00 - $145,000.00

    The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.

    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 • Washington, DC, United States

    Job_description.internal_linking.related_jobs
    Travel MRI Tech - $2,909 per week in Baltimore, MD

    Travel MRI Tech - $2,909 per week in Baltimore, MD

    Medical Solutions • Columbia, Maryland, US
    serp_jobs.job_card.full_time
    A facility in Baltimore, MD is seeking its next amazing MRI Technologist.Read on if this sounds like your perfect fit!.Nurses and allied healthcare professionals are in high demand nationwide, and ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel Nurse RN - ED - Emergency Department

    Travel Nurse RN - ED - Emergency Department

    Health Advocates Network - Nursing • La Plata, MD, US
    serp_jobs.job_card.full_time
    Health Advocates Network - Nursing is seeking a travel nurse RN ED - Emergency Department for a travel nursing job in La Plata, Maryland. Job Description & Requirements.Pay package is based on 1...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Travel MRI Tech - $2,702 to $2,902 per week in Baltimore, MD

    Travel MRI Tech - $2,702 to $2,902 per week in Baltimore, MD

    Titan Medical Group • Columbia, Maryland, US
    serp_jobs.job_card.full_time
    ARRT(MR) / BCLS / BLS - American Heart Association.Titan Medical is looking for travelers to fill a Travel MRI Tech position for a 13 week assignment in Baltimore, ! Call Titan for additional details.serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel MRI Tech - $2,383 to $2,740 per week in Baltimore, MD

    Travel MRI Tech - $2,383 to $2,740 per week in Baltimore, MD

    Fusion Medical Staffing • Columbia, Maryland, US
    serp_jobs.job_card.full_time
    Facility in Baltimore, Maryland.Fusion Medical Staffing is seeking a skilled MRI Tech for a 13-week travel assignment in Baltimore, Maryland. As a member of our team, you'll have the opportunity to ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel CT Tech - $3,202 to $3,509 per week in Lutherville Timonium, MD

    Travel CT Tech - $3,202 to $3,509 per week in Lutherville Timonium, MD

    AMN Healthcare Allied • Columbia, Maryland, US
    serp_jobs.job_card.full_time
    Job Description & Requirements.Computed Tomography Technologist - (CT Tech) .StartDate : 12 / 8 / 2025 Available Shifts : 8 D / E Pay Rate : $3202. CT Tech for Timonium, MD MD Rad Tech License CT Cert...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Site Medical Director

    Site Medical Director

    AMN Healthcare • Commerce, US
    serp_jobs.job_card.full_time
    Job Description & Requirements.StartDate : ASAP Pay Rate : $280000.AltaMed, a leading healthcare center providing services to more than 300,000 Southern California residents, is seeking a qualified p...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Medical Director, Labor & Delivery

    Medical Director, Labor & Delivery

    Virginia Hospital Center • Arlington, US
    serp_jobs.job_card.full_time
    VHC Health Hospital is seeking a visionary Medical Director to lead our Labor and Delivery department.This key leadership position offers a unique opportunity to shape the future of obstetrics, ins...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Associate Editor, Physical Review Letters

    Associate Editor, Physical Review Letters

    American Physical Society • College Park, MD, United States
    serp_jobs.job_card.full_time
    Associate Editor, Physical Review Letters.The American Physical Society is a nonprofit membership organization working to advance physics by fostering a vibrant, inclusive, and global community ded...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Travel MRI Tech - $2,935 per week in Baltimore, MD

    Travel MRI Tech - $2,935 per week in Baltimore, MD

    Cross Country Allied • Columbia, Maryland, US
    serp_jobs.job_card.full_time
    As an MRI technologist, you will take medical images of patients for diagnostic purposes using magnetic resonance imaging. Working in a hospital, outpatient center, private practice, imaging center ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel MRI Tech - $2,377 to $2,635 per week in Baltimore, MD

    Travel MRI Tech - $2,377 to $2,635 per week in Baltimore, MD

    LRS Healthcare • Columbia, Maryland, US
    serp_jobs.job_card.full_time
    Ready to start your next travel adventure? LRS Healthcare offers a full benefits package, 24 / 7 support, and a responsive, traveler-first culture. What are you waiting for? Apply today!.Valid license...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Physician, Family Medicine Opportunities in IL, MO, OK, and WI

    Physician, Family Medicine Opportunities in IL, MO, OK, and WI

    SSM Health • Mount Vernon, US
    serp_jobs.job_card.full_time
    SSM Health is an Equal Opportunity Employer : .We have become an employer of choice for physicians across the globe because of our diverse practice opportunities, clinical innovation, commitment to p...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    CRNA - Anesthesiology job available in La Plata, Maryland

    CRNA - Anesthesiology job available in La Plata, Maryland

    NorthStar Anesthesia • La Plata, MD, US
    serp_jobs.job_card.full_time
    Are you currently enrolled in SRNA program or a newly graduated CRNA ready to take the next step in your career? At NorthStar, were excited to welcome the next generation of CRNA professionals!.Nor...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Travel Labor & Delivery RN

    Travel Labor & Delivery RN

    Nightingale Nurses • Clinton, MD, US
    serp_jobs.job_card.full_time
    Nightingale Nurses is seeking a travel nurse RN Labor and Delivery for a travel nursing job in Clinton, Maryland.Job Description & Requirements. You may not realize it, but as an RN with real wo...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Travel MRI Tech - $2,383 to $2,740 per week in Baltimore, MD

    Travel MRI Tech - $2,383 to $2,740 per week in Baltimore, MD

    AlliedTravelNetwork • Columbia, Maryland, US
    serp_jobs.job_card.full_time
    AlliedTravelNetwork is working with Fusion Medical Staffing to find a qualified MRI Tech in Baltimore, Maryland, 21287!.Facility in Baltimore, Maryland. Fusion Medical Staffing is seeking a skilled ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel Surgical Tech - Certified - $1686.4 / Week

    Travel Surgical Tech - Certified - $1686.4 / Week

    CrossMed Healthcare • Columbia, MD, US
    serp_jobs.job_card.full_time
    CrossMed Healthcare is seeking an experienced Surgical Tech - Certified for an exciting Travel Allied job in Columbia, MD. Shift : Inquire Start Date : 01 / 12 / 2026 Duration : 12 weeks Pay : $1686.At Cros...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    AI Trainer -Freelance Writer

    AI Trainer -Freelance Writer

    Outlier • Columbia, MD, United States
    serp_jobs.job_card.full_time
    Earn up to $16 USD / hourly and work remotely and flexibly.Outlier, a platform owned and operated by Scale AI, is looking for. If you're passionate about improving models and excited by the future of ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Grant Writer (Corporate and Foundation)

    Grant Writer (Corporate and Foundation)

    Food & Friends • Washington, DC, US
    serp_jobs.job_card.full_time
    Founded in 1988, Food & Friends provides medically-tailored meals, nutrition support, and friendship to people living with AIDS, cancer, diabetes, and other life-challenging illnesses.Our team of s...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel Medical Technologist - $63 to $77 per hour in Gaithersburg, MD

    Travel Medical Technologist - $63 to $77 per hour in Gaithersburg, MD

    AlliedTravelCareers • Columbia, Maryland, US
    serp_jobs.job_card.full_time
    AlliedTravelCareers is working with All Medical Personnel to find a qualified Medical Technologist in Gaithersburg, Maryland, 20877!. Position : Medical Lab Technologist.Determine the acceptability o...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted