Talent.com
Principal Medical Writer - Regulatory Submission Documents
Principal Medical Writer - Regulatory Submission DocumentsSyneos Health/ inVentiv Health Commercial LLC • Salt Lake City, UT, United States
Principal Medical Writer - Regulatory Submission Documents

Principal Medical Writer - Regulatory Submission Documents

Syneos Health / inVentiv Health Commercial LLC • Salt Lake City, UT, United States
[job_card.variable_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Principal Medical Writer - Regulatory Submission 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
  • 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 • Salt Lake City, UT, United States

    [internal_linking.related_jobs]
    Freelance Research Contributor (Hiring Immediately)

    Freelance Research Contributor (Hiring Immediately)

    Maxion Research • Saratoga Springs, Utah, US
    [job_card.part_time]
    Join Our Part-Time Research Studies Today!.Are you eager to earn extra income from the comfort of your home? We are looking for motivated individuals to participate in paid research studies includi...[show_more]
    [last_updated.last_updated_30] • [promoted]
    AI Trainer -Freelance Writer

    AI Trainer -Freelance Writer

    Outlier • Salt Lake City, UT, 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]
    Physician - Family Medicine

    Physician - Family Medicine

    Trinity Health • Saratoga Springs, US
    [job_card.full_time]
    Peters Health Partners Medical Associates is thrilled to offer a full-time Family Medicine physician position at our brand-new primary care practice located at 631 Maple Ave in Wilton, NY.This is a...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Donor Center Phlebotomist

    Donor Center Phlebotomist

    American Red Cross • Lehi, UT, United States
    [job_card.full_time]
    Please use Google Chrome or Mozilla Firefox when accessing Candidate Home.By joining the American Red Cross you will touch millions of lives every year and experience the greatness of the human spi...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Medical Affairs Field Director

    Medical Affairs Field Director

    Scientific Search • Salt Lake City, UT, US
    [job_card.full_time]
    A commercial-stage biotechnology company developing cell and immunotherapy products to eliminate cancerous or infected cells. Engage in the exchange of scientific data and education of health care p...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Assistant Professor, Associate Professor, or Professor – Tenure Track in the Department of Dermatology

    Assistant Professor, Associate Professor, or Professor – Tenure Track in the Department of Dermatology

    University of Utah Department of Dermatology • Salt Lake City, US
    [job_card.full_time]
    Tenure-Track Faculty Position in the Department of Dermatology : Allergy and Immunology .Assistant Professor, Associate Professor, or Professor – Tenure Track .Rank dependent upon ex...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Assistant Professor, Associate Professor, or Professor – Tenure Track in the Department of Dermatology

    Assistant Professor, Associate Professor, or Professor – Tenure Track in the Department of Dermatology

    HealthEcareers - Client • Salt Lake City, UT, USA
    [job_card.full_time]
    Tenure-Track Faculty Position in the Department of Dermatology : Allergy and Immunology .Assistant Professor, Associate Professor, or Professor – Tenure Track . Rank dependent upon experience) .The D...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Regulatory Affairs Specialist

    Regulatory Affairs Specialist

    bioMerieux Inc. • Salt Lake City, UT, United States
    [job_card.full_time]
    An RA Specialist on the Regulatory Affairs Lifecycle Management (RA LCM) team is responsible for developing regulatory strategies and assessing regulatory risks related to product changes throughou...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Remote M&A Associate - AI Trainer ($50-$60 / hour)

    Remote M&A Associate - AI Trainer ($50-$60 / hour)

    Data Annotation • Lehi, Utah
    [filters.remote]
    [job_card.full_time] +1
    We are looking for a finance professional to join our team to train AI models.You will measure the progress of these AI chatbots, evaluate their logic, and solve problems to improve the quality of ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Lab Services Procedure & Training Document Developer

    Lab Services Procedure & Training Document Developer

    American Red Cross • Salt Lake City, UT, United States
    [job_card.full_time]
    Please use Google Chrome or Mozilla Firefox when accessing Candidate Home.By joining the American Red Cross you will touch millions of lives every year and experience the greatness of the human spi...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Oral Surgery Partnership

    Oral Surgery Partnership

    HealthEcareers - Client • Farmington, UT, USA
    [job_card.full_time]
    We’re excited to offer an immediate opportunity for an oral surgeon to join our established practice in the northern Utah valley. This is an incredible opportunity to join a group of thriving OMS pr...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    DVM Medical Director - Co-Owner

    DVM Medical Director - Co-Owner

    Peoplepack LLC - Recruiting Solutions • Lehi, UT, US
    [job_card.full_time]
    We are recruiting for an entrepreneurial Veterinarian leader who is interested in managing a NEW stand-alone GP hospital, as a co-owner, building and leading a veterinary team, while reaping the fi...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Remote Bilingual Traditional Chinese Medical Expert - AI Trainer ($100-$160 per hour)

    Remote Bilingual Traditional Chinese Medical Expert - AI Trainer ($100-$160 per hour)

    Mercor • Lehi, Utah, US
    [filters.remote]
    [job_card.full_time]
    Mercor is seeking • •native Mandarin speakers • • who can read / write in • •Traditional Chinese • • and are also • •medical professionals • • based in Taiwan. This role combines your • •clinical expertise • • wi...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Remote FP&A Manager – AI Trainer ($50-$60 / hour)

    Remote FP&A Manager – AI Trainer ($50-$60 / hour)

    Data Annotation • Lehi, Utah
    [filters.remote]
    [job_card.full_time] +1
    We are looking for a finance professional to join our team to train AI models.You will measure the progress of these AI chatbots, evaluate their logic, and solve problems to improve the quality of ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Telemedicine Physician

    Telemedicine Physician

    QuickMD • Lehi, UT, US
    [job_card.full_time]
    QuickMD is a leading telemedicine provider, delivering high-quality virtual care across 44 states.Since our founding in 2019, we have helped more than 100,000 patients access essential medical trea...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Medical Science Liaison - Nephrology

    Senior Medical Science Liaison - Nephrology

    Ardelyx • Salt Lake City, UT, United States
    [job_card.full_time]
    Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medic...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Inpatient Medical Medical Director - Child & Adolescent Psychiatry | Utah

    Inpatient Medical Medical Director - Child & Adolescent Psychiatry | Utah

    Jackson Physician Search • Salt Lake City, US
    [job_card.full_time]
    An established pediatric behavioral health hospital is seeking a board certified or board eligible child psychiatrist to join their growing team. Situated in a thriving, fast-growing metro, Salt Lak...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Family Medicine Physician - St. Peter's Primary Care

    Family Medicine Physician - St. Peter's Primary Care

    Trinity Health • Saratoga Springs, US
    [job_card.full_time]
    Peters Health Partners Medical Associates.This is an exciting opportunity to join an existing outpatient practice with strong patient demand and hospital affiliated practice support!.Congress Place...[show_more]
    [last_updated.last_updated_30] • [promoted]