Talent.com
Principal Medical Writer
Principal Medical WriterSyneos Health/ inVentiv Health Commercial LLC • Honolulu, HI, United States
Principal Medical Writer

Principal Medical Writer

Syneos Health / inVentiv Health Commercial LLC • Honolulu, HI, United States
22 days ago
Job type
  • Full-time
Job description

Principal Medical Writer

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.

    Create a job alert for this search

    Principal Medical Writer • Honolulu, HI, United States

    Related jobs
    Float Nurse Aide

    Float Nurse Aide

    Wilson Care Group • Aina Haina, Hawaii
    Full-time
    Quick Apply
    Join Wilson Homecare's On-Call Float Program – CAREGIVERS WANTED! Up to $1500 Sign On Bonus & Full-Time Benefits & Salary! $40k-$54k Annual Salary! Apply Today!.Are you an...Show more
    Last updated: 30+ days ago • Promoted
    Medical Management Policy & Research Analyst I

    Medical Management Policy & Research Analyst I

    HMSA • Honolulu, HI, United States
    Full-time
    Revise and / or develop medical policies adopted from the BCBSA in conjunction with assigned medical director and in accordance with Development and Approval of Medical Policy administrative policy; ...Show more
    Last updated: 30+ days ago • Promoted
    Nurse Aide - Earn $1,000 Weekly - Flexible schedule

    Nurse Aide - Earn $1,000 Weekly - Flexible schedule

    Wilson Care Group • Waianae, Hawaii
    Full-time
    Quick Apply
    Join Our Compassionate Home Care Team – Nurse Aides Wanted! $1500 Sign On Bonus for Qualified Caregivers.Are you a dedicated and compassionate nurse aide looking to make a positive impa...Show more
    Last updated: 30+ days ago • Promoted
    Medical Management Review Analyst I

    Medical Management Review Analyst I

    HMSA • Honolulu, HI, United States
    Full-time
    Analyzes, researches, and interprets medical and claims data while processing authorization requests.Authorizes requests that clearly meet specified criteria according to department guidelines.Refe...Show more
    Last updated: 30+ days ago • Promoted
    Part Time - Home Health Aide (HHA)

    Part Time - Home Health Aide (HHA)

    Wilson Care Group • North Shore, Hawaii
    Full-time
    Quick Apply
    Ask how you can make up to $1500 in bonuses! .We hire all care levels from Nurse Aides without a CNA or schooling to Certified Caregivers with extensive experience. We look forward to having yo...Show more
    Last updated: 30+ days ago • Promoted
    Telemedicine Physician

    Telemedicine Physician

    QuickMD • Waimanalo, HI, US
    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: 30+ days ago • Promoted
    Medical Management Compliance Analyst

    Medical Management Compliance Analyst

    HMSA • Honolulu, HI, United States
    Full-time
    Monitor and analyze regulatory / accreditation / business requirements to invoke recommendations for program and / or policy changes as appropriate for various lines of business. Lead / coordinate activitie...Show more
    Last updated: 30+ days ago • Promoted
    Principal Medical Writer

    Principal Medical Writer

    Syneos Health / inVentiv Health Commercial LLC • Honolulu, HI, United States
    Full-time
    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 ...Show more
    Last updated: 30+ days ago • Promoted
    Home Health Aide

    Home Health Aide

    Wilson Care Group • North Shore, Hawaii
    Full-time
    Quick Apply
    Ask how you can make up to $1500 in bonuses! .We hire all care levels from Nurse Aides without a CNA or schooling to Certified Caregivers with extensive experience. We look forward to having yo...Show more
    Last updated: 30+ days ago • Promoted
    Entry Level Home Health Aide

    Entry Level Home Health Aide

    Wilson Care Group • North Shore, Hawaii
    Full-time
    Quick Apply
    Ask how you can make up to $1500 in bonuses! .We hire all care levels from Nurse Aides without a CNA or schooling to Certified Caregivers with extensive experience. We look forward to having yo...Show more
    Last updated: 30+ days ago • Promoted
    Medical Case Review Assistant

    Medical Case Review Assistant

    Bishop & Company, Inc. • Honolulu, HI, US
    Temporary
    Bishop & Company is seeking a.Assistant to work in Medical Management supporting medical cases.Ideal candidates will have strong computer skills and the ability to multi-task.This person w...Show more
    Last updated: 20 days ago • Promoted
    Delivery Driver - Sign Up and Start Earning

    Delivery Driver - Sign Up and Start Earning

    DoorDash • Waianae, HI, United States
    Full-time +1
    DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day. As a Dasher, you’ll stay busy with a variety o...Show more
    Last updated: 1 day ago • Promoted
    Home Health Aide - Earn $1,000 weekly pay

    Home Health Aide - Earn $1,000 weekly pay

    Wilson Care Group • Waianae, Hawaii
    Full-time
    Quick Apply
    Ask how you can make up to $1500 in bonuses! .We hire all care levels from Nurse Aides without a CNA or schooling to Certified Caregivers with extensive experience. We look forward to having yo...Show more
    Last updated: 30+ days ago • Promoted
    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Syneos Health / inVentiv Health Commercial LLC • Honolulu, HI, United States
    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...Show more
    Last updated: 30+ days ago • Promoted
    Principal / Sr Medical Writer (Regulatory & Publications)

    Principal / Sr Medical Writer (Regulatory & Publications)

    Syneos Health / inVentiv Health Commercial LLC • Honolulu, HI, United States
    Full-time
    Principal / Sr Medical Writer (Regulatory & Publications).Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We translate unique...Show more
    Last updated: 1 day ago • Promoted
    Home Health Aide - Wilson Care Group

    Home Health Aide - Wilson Care Group

    Wilson Care Group • Waianae, Hawaii
    Full-time
    Quick Apply
    Ask how you can make up to $1500 in bonuses! .We hire all care levels from Nurse Aides without a CNA or schooling to Certified Caregivers with extensive experience. We look forward to having yo...Show more
    Last updated: 30+ days ago • Promoted
    Nurse Aide - Earn $1,000 Weekly Pay

    Nurse Aide - Earn $1,000 Weekly Pay

    Wilson Care Group • North Shore, Hawaii
    Full-time
    Quick Apply
    Join Our Compassionate Home Care Team – Nurse Aides Wanted! $1500 Sign On Bonus for Qualified Caregivers.Are you a dedicated and compassionate nurse aide looking to make a positive impa...Show more
    Last updated: 30+ days ago • Promoted
    Nurse Aide - $16-$22 Hourly Pay

    Nurse Aide - $16-$22 Hourly Pay

    Wilson Care Group • North Shore, Hawaii
    Full-time
    Quick Apply
    Join Our Compassionate Home Care Team – Nurse Aides Wanted! $1500 Sign On Bonus for Qualified Caregivers.Are you a dedicated and compassionate nurse aide looking to make a positive impa...Show more
    Last updated: 30+ days ago • Promoted