Talent.com
Principal Medical Writer - Publications
Principal Medical Writer - PublicationsSyneos Health/ inVentiv Health Commercial LLC • Miami, FL, United States
Principal Medical Writer - Publications

Principal Medical Writer - Publications

Syneos Health / inVentiv Health Commercial LLC • Miami, FL, United States
[job_card.variable_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Principal Medical Writer - Publications

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%).
  • Qualifications :

  • 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.
  • 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 • Miami, FL, United States

    [internal_linking.similar_jobs]
    Locum Physician (MD / DO) - Emergency Medicine - $295 to $305 per hour in Panama City Beach, FL

    Locum Physician (MD / DO) - Emergency Medicine - $295 to $305 per hour in Panama City Beach, FL

    LocumJobsOnline • Miami, Florida, US
    [job_card.full_time]
    Doctor of Medicine | Emergency Medicine.LocumJobsOnline is working with Aya Locums to find a qualified Emergency Medicine MD in Panama City Beach, Florida, 32401!. Aya Locums has an immediate openin...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Locum Physician (MD / DO) - Emergency Medicine in Fort Pierce, FL

    Locum Physician (MD / DO) - Emergency Medicine in Fort Pierce, FL

    LocumJobsOnline • Miami, US
    [job_card.full_time]
    Doctor of Medicine | Emergency Medicine.Competitive weekly pay (inquire for details) .LocumJobsOnline is working with Rhino Medical to find a qualified Emergency Medicine MD in Fort Pierce, Florida...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel Medical Assistant (MA) - $715 per week in Pinellas Park, FL

    Travel Medical Assistant (MA) - $715 per week in Pinellas Park, FL

    AlliedTravelCareers • Miami, Florida, US
    [job_card.full_time] +1
    AlliedTravelCareers is working with Infojini Healthcare to find a qualified Medical Assistant in Pinellas Park, Florida, 33780!. Medical Assistant travel Medical Assistant needed in Pinellas Park, F...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Locum Physician (MD / DO) - Emergency Medicine in Panama City, FL

    Locum Physician (MD / DO) - Emergency Medicine in Panama City, FL

    LocumJobsOnline • Miami, Florida, US
    [job_card.full_time] +1
    Doctor of Medicine | Emergency Medicine.Competitive weekly pay (inquire for details) .LocumJobsOnline is working with VISTA Staffing to find a qualified Emergency Medicine MD in Panama City, Florid...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel CVOR Tech - $2,216 to $2,357 per week in Tallahassee, FL

    Travel CVOR Tech - $2,216 to $2,357 per week in Tallahassee, FL

    AlliedTravelCareers • Miami, Florida, US
    [job_card.full_time]
    Facility in Tallahassee, Florida.Fusion Medical Staffing is seeking a skilled CVOR Surgical Technologist for a 13-week travel assignment in Tallahassee, Florida. As a member of our team, you'll have...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Underwriter - Miscellaneous Medical & Life Sciences - South Region

    Underwriter - Miscellaneous Medical & Life Sciences - South Region

    Beazley Group • Miami, FL, United States
    [job_card.full_time]
    Underwriter - Miscellaneous Medical.As per Beazley's organisation chart.Brokers, Underwriters, Claims staff, Coverholders, external Clients and Suppliers. To underwrite a Miscellaneous Medical & Lif...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel Medical Technologist - $1,430 per week in Wauchula, FL

    Travel Medical Technologist - $1,430 per week in Wauchula, FL

    AlliedTravelCareers • Miami, Florida, US
    [job_card.full_time]
    AlliedTravelCareers is working with OneStaff Medical to find a qualified Medical Technologist in Wauchula, Florida, 33873!. An independently-owned, nationally-recognized and amazingly awesome staffi...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel Medical Assistant (MA) - $655 per week in Delray Beach, FL

    Travel Medical Assistant (MA) - $655 per week in Delray Beach, FL

    AlliedTravelCareers • Miami, Florida, US
    [job_card.full_time] +1
    AlliedTravelCareers is working with Infojini Healthcare to find a qualified Medical Assistant in Delray Beach, Florida, 33484!. Medical Assistant travel Medical Assistant needed in Delray Beach, Flo...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel Medical Technologist - $1,215 to $1,415 per week in Key West, FL

    Travel Medical Technologist - $1,215 to $1,415 per week in Key West, FL

    AlliedTravelCareers • Miami, Florida, US
    [job_card.full_time] +1
    Jackson HealthPros is hiring a Clinical / Medical Laboratory Scientist (formerly Medical Technologist) to perform diagnostic testing on patient samples and analyze test results for accuracy, accept...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel Medical Technologist - $1,202 to $1,382 per week in Sebring, FL

    Travel Medical Technologist - $1,202 to $1,382 per week in Sebring, FL

    AlliedTravelCareers • Miami, Florida, US
    [job_card.full_time]
    Travel Medical Laboratory Technician (MLT) - Generalist.Fusion Medical Staffing is seeking a skilled Medical Laboratory Technician for a 13 week travel assignment in Sebring, FL.As a member of our ...[show_more]
    [last_updated.last_updated_1_hour] • [promoted] • [new]
    Travel Medical Technologist - $1,559 to $1,774 per week in Naples, FL

    Travel Medical Technologist - $1,559 to $1,774 per week in Naples, FL

    AlliedTravelCareers • Miami, Florida, US
    [job_card.full_time] +1
    AlliedTravelCareers is working with Aya Healthcare to find a qualified Medical Technologist in Naples, Florida, 34101!.Aya Healthcare has an immediate opening for the following position : Medical Te...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel Medical Assistant (MA) - $20 to $23 per hour in Orlando, FL

    Travel Medical Assistant (MA) - $20 to $23 per hour in Orlando, FL

    AlliedTravelCareers • Miami, Florida, US
    [job_card.full_time] +2
    AlliedTravelCareers is working with Pride Health to find a qualified Medical Assistant in Orlando, Florida, 32801!.REQUIRED : Please provide detailed answers to the below questions : .What are the top...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Locum Physician (MD / DO) - Emergency Medicine - $260 to $270 per hour in Fort Pierce, FL

    Locum Physician (MD / DO) - Emergency Medicine - $260 to $270 per hour in Fort Pierce, FL

    LocumJobsOnline • Miami, Florida, US
    [job_card.full_time]
    Doctor of Medicine | Emergency Medicine.LocumJobsOnline is working with Aya Locums to find a qualified Emergency Medicine MD in Fort Pierce, Florida, 34945!. Aya Locums has an immediate opening for ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Remote Medical General Expert - AI Trainer

    Remote Medical General Expert - AI Trainer

    SuperAnnotate • Miami, Florida, US
    [filters.remote]
    [job_card.full_time]
    In this hourly, remote contractor role, you will review AI-generated medical responses and / or generate expert healthcare content, evaluating reasoning quality and step-by-step clinical problem-solv...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel Medical Assistant (MA) - $21 to $23 per hour in Stuart, FL

    Travel Medical Assistant (MA) - $21 to $23 per hour in Stuart, FL

    AlliedTravelCareers • Miami, Florida, US
    [job_card.full_time] +1
    AlliedTravelCareers is working with Pride Health to find a qualified Medical Assistant in Stuart, Florida, 34994!.This is a temporary assignment opportunity and a great way to start working with a ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel Medical Assistant (MA) - $718 per week in Delray Beach, FL

    Travel Medical Assistant (MA) - $718 per week in Delray Beach, FL

    AlliedTravelCareers • Miami, Florida, US
    [job_card.full_time] +1
    AlliedTravelCareers is working with Infojini Healthcare to find a qualified Medical Assistant in Delray Beach, Florida, 33484!. Medical Assistant travel Medical Assistant needed in Delray Beach, Flo...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Locum Physician (MD / DO) - Emergency Medicine - $295 to $305 per hour in Panama City, FL

    Locum Physician (MD / DO) - Emergency Medicine - $295 to $305 per hour in Panama City, FL

    LocumJobsOnline • Miami, Florida, US
    [job_card.full_time]
    Doctor of Medicine | Emergency Medicine.LocumJobsOnline is working with Aya Locums to find a qualified Emergency Medicine MD in Panama City, Florida, 32401!. Aya Locums has an immediate opening for ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel Medical Technologist - $1,438 per week in Wauchula, FL

    Travel Medical Technologist - $1,438 per week in Wauchula, FL

    AlliedTravelCareers • Miami, Florida, US
    [job_card.full_time]
    Travel Laboratory : Medical Technologist Wauchula.Shift Details : 12H Nights (7 : 00 PM-7 : 00 AM).Length : 13 WEEKS 13 weeks. Apply for specific facility details.[show_more]
    [last_updated.last_updated_variable_days] • [promoted]