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 • Minneapolis, MN, 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 • Minneapolis, MN, United States
[job_card.variable_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
  • [filters.remote]
[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.

    [job_alerts.create_a_job]

    Medical Writer • Minneapolis, MN, United States

    [internal_linking.similar_jobs]
    Travel Medical Technologist - $1,077 to $1,195 per week in Rochester, MN

    Travel Medical Technologist - $1,077 to $1,195 per week in Rochester, MN

    AlliedTravelNetwork • Minneapolis, Minnesota, US
    [job_card.full_time]
    AlliedTravelNetwork is working with LRS Healthcare to find a qualified Medical Technologist in Rochester, Minnesota, 55905!. Ready to start your next travel adventure? LRS Healthcare offers a full b...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Medical Sales Account Executive

    Medical Sales Account Executive

    Rotech Healthcare Inc. • Apple Valley, MN, United States
    [job_card.full_time]
    Join a Leader in Home Healthcare.As a national leader in ventilators, oxygen therapy, sleep apnea treatment, wound care, diabetic solutions, and other home medical equipment, we empower patients to...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel Nurse RN - Medical-Surgical - $1,894 per week in Warren, MN

    Travel Nurse RN - Medical-Surgical - $1,894 per week in Warren, MN

    TravelNurseSource • Minneapolis, Minnesota, US
    [job_card.full_time]
    TravelNurseSource is working with GetMed Staffing to find a qualified Med / Surg RN in Warren, Minnesota, 56762!.GetMed Staffing is searching for a strong MedSurg RN to assist our traveler-friendly c...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    AI Trainer -Freelance Writer

    AI Trainer -Freelance Writer

    Outlier • Minneapolis, MN, United States
    [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 ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel Medical Technologist - $1,067 per week in Rochester, MN

    Travel Medical Technologist - $1,067 per week in Rochester, MN

    AlliedTravelNetwork • Minneapolis, Minnesota, US
    [job_card.full_time]
    AlliedTravelNetwork is working with Triage Staffing LLC to find a qualified Medical Technologist in Rochester, Minnesota, 55901!. Travel Laboratory : Clinical Laboratory Scientist Rochester, MN.Locat...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Home-Based Freelance Writer

    Home-Based Freelance Writer

    Outlier • Minneapolis, MN, United States
    [filters.remote]
    [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 ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel MRI Technologist - $2,883 per week

    Travel MRI Technologist - $2,883 per week

    Premier Medical Staffing Services • Robbinsdale, MN, United States
    [job_card.permanent]
    Premier Medical Staffing Services is seeking a travel MRI Technologist for a travel job in Robbinsdale, Minnesota.Job Description & Requirements. Premier Medical Staffing Job ID #606034.Pay package ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel Medical Technologist - $1,067 per week in Rochester, MN

    Travel Medical Technologist - $1,067 per week in Rochester, MN

    Triage Staffing LLC • Minneapolis, Minnesota, US
    [job_card.full_time]
    Travel Laboratory : Clinical Laboratory Scientist Rochester, MN.Location : Rochester, MN.Shift Details : 8H Days (12 : 00 AM-12 : 00 PM). Length : 52 WEEKS 52 weeks.Apply for specific f...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Locum Physician (MD / DO) - Surgery - General / Other in Coon Rapids, MN

    Locum Physician (MD / DO) - Surgery - General / Other in Coon Rapids, MN

    LocumJobsOnline • Coon Rapids, MN, US
    [job_card.full_time] +2
    LocumJobsOnline is working with VieMed Healthcare Staffing to find a qualified General Surgery MD in Coon Rapids, Minnesota, 55433!. Partner with VHS in our mission to elevate healthcare staffing to...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Sr Medical Writer Publications - Sponsor Dedicated - Remote Based

    Sr Medical Writer Publications - Sponsor Dedicated - Remote Based

    Syneos Health / inVentiv Health Commercial LLC • Minneapolis, MN, United States
    [filters.remote]
    [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...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Locum Physician (MD / DO) - Surgery - General / Other - $280 to $315 per hour in Coon Rapids, MN

    Locum Physician (MD / DO) - Surgery - General / Other - $280 to $315 per hour in Coon Rapids, MN

    LocumJobsOnline • Coon Rapids, MN, US
    [job_card.full_time]
    LocumJobsOnline is working with Aya Locums to find a qualified General Surgery MD in Coon Rapids, Minnesota, 55433!.Aya Locums has an immediate opening for a locum Surgery Cardiovascular job in Coo...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel Medical Technologist - $1,077 to $1,195 per week in Rochester, MN

    Travel Medical Technologist - $1,077 to $1,195 per week in Rochester, MN

    AlliedTravelCareers • Minneapolis, Minnesota, US
    [job_card.full_time]
    AlliedTravelCareers is working with LRS Healthcare to find a qualified Medical Technologist in Rochester, Minnesota, 55905!. Ready to start your next travel adventure? LRS Healthcare offers a full b...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel Medical Laboratory Technician (MLT) - $954 to $1,103 per week in Rochester, MN

    Travel Medical Laboratory Technician (MLT) - $954 to $1,103 per week in Rochester, MN

    Host Healthcare • Minneapolis, Minnesota, US
    [job_card.full_time]
    Host Healthcare is an award-winning travel healthcare company with an immediate opening for this Medical Laboratory Technician position in Rochester, MN. If you are interested in this position, plea...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Medical Science Liaison (Remote)

    Medical Science Liaison (Remote)

    Jazz Pharmaceuticals • Minneapolis, MN, United States
    [filters.remote]
    [job_card.full_time]
    If you are a current Jazz employee please apply via the Internal Career site.Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Medicare Product Manager IV

    Medicare Product Manager IV

    Medica • Minnetonka, MN, United States
    [job_card.full_time]
    Medica is a nonprofit health plan with more than a million members that serves communities in Minnesota, Nebraska, Wisconsin, Missouri, and beyond. We deliver personalized health care experiences an...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Experienced SDS Author (Remote)

    Experienced SDS Author (Remote)

    Pace Analytical Services, LLC • Minneapolis, MN, United States
    [filters.remote]
    [job_card.full_time]
    Monday through Friday, 8 : 00 AM - 4 : 30 PM.Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward. to innovate and advance all aspects ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Managing Veterinarian / Medical Director

    Managing Veterinarian / Medical Director

    National Veterinary Associates • ISANTI, Minnesota, United States
    [job_card.permanent]
    Lead, Mentor, and Grow with Us.Francis Veterinary Clinic | Isanti, MN.Francis Veterinary Clinic is growing fast, and we’re ready to welcome a. If you’re an experienced DVM ready to step into leaders...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel Medical Technologist - $1,077 to $1,195 per week in Rochester, MN

    Travel Medical Technologist - $1,077 to $1,195 per week in Rochester, MN

    LRS Healthcare • Minneapolis, Minnesota, US
    [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...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]