Talent.com
Principal Medical Writer

Principal Medical Writer

Syneos Health / inVentiv Health Commercial LLCHonolulu, HI, United States
30+ 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

    Medical Writer • Honolulu, HI, United States

    Related jobs
    • Promoted
    Nurse Aide - Earn $1,000 Weekly - Flexible schedule

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

    Wilson Care GroupNorth 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 moreLast updated: 30+ days ago
    • Promoted
    Entry Level Home Health Aide

    Entry Level Home Health Aide

    Wilson Care GroupWaianae, 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 moreLast updated: 30+ days ago
    • Promoted
    Travel Nurse RN - Home Health in Kaneohe, HI

    Travel Nurse RN - Home Health in Kaneohe, HI

    TravelNurseSourceKaneohe, HI, US
    Full-time
    TravelNurseSource is working with Titan Medical Group to find a qualified Home Health RN in Kaneohe, Hawaii, 96744!.Titan Medical is looking for travelers to fill a Travel Home Health position for ...Show moreLast updated: 30+ days ago
    • Promoted
    Travel Nurse RN - Home Health - $2,377 per week in Kaneohe, HI

    Travel Nurse RN - Home Health - $2,377 per week in Kaneohe, HI

    TravelNurseSourceKaneohe, HI, US
    Full-time +1
    TravelNurseSource is working with Nationwide Therapy Group to find a qualified Home Health RN in Kaneohe, Hawaii, 96744!. NTG is committed to matching you to the right position and we pride ourselve...Show moreLast updated: 11 days ago
    • Promoted
    Part Time - Home Health Aide (HHA)

    Part Time - Home Health Aide (HHA)

    Wilson Care GroupNorth 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 moreLast updated: 30+ days ago
    • Promoted
    CNA - Weekly Salary

    CNA - Weekly Salary

    Wilson Care GroupWaianae, Hawaii
    Full-time
    Quick Apply
    Certified Nurse Aide - Wilson Care Group- Full-Time-salary $700+ weekly pay ($1500+ bonus).Looking to make money as a Qualified Caregiver? Do you have 6 months+ experience? Can you handle the full ...Show moreLast updated: 30+ days ago
    • Promoted
    Home Health Aide

    Home Health Aide

    Wilson Care GroupWaianae, 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 moreLast updated: 30+ days ago
    • Promoted
    Nurse Aide - $16-$22 Hourly Pay

    Nurse Aide - $16-$22 Hourly Pay

    Wilson Care GroupWaianae, 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 moreLast updated: 30+ days ago
    • Promoted
    Sr Principal / Principal Medical Writer (Publication Strategy / Planning) - East Coast Preferred - Single Sponsor

    Sr Principal / Principal Medical Writer (Publication Strategy / Planning) - East Coast Preferred - Single Sponsor

    Syneos Health / inVentiv Health Commercial LLCHonolulu, HI, United States
    Full-time
    Sr Principal / Principal Medical Writer (Publication Strategy / Planning) - East Coast Preferred - Single Sponsor.Syneos Health is a leading fully integrated biopharmaceutical solutions organization ...Show moreLast updated: 10 days ago
    • Promoted
    Travel Nurse RN - Home Health - $2,155 to $2,308 per week in Kaneohe, HI

    Travel Nurse RN - Home Health - $2,155 to $2,308 per week in Kaneohe, HI

    TravelNurseSourceKaneohe, HI, US
    Full-time
    TravelNurseSource is working with Host Healthcare to find a qualified Home Health RN in Kaneohe, Hawaii, 96744!.Host Healthcare is an award-winning travel healthcare company with an immediate openi...Show moreLast updated: 24 days ago
    • Promoted
    Float Nurse Aide

    Float Nurse Aide

    Wilson Care GroupHawaii Kai, 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 moreLast updated: 30+ days ago
    • Promoted
    Nurse Aide (FLOAT) - On-Call Program

    Nurse Aide (FLOAT) - On-Call Program

    Wilson Care GroupAina 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 moreLast updated: 30+ days ago
    • Promoted
    Nurse Aide - Earn $1,000 Weekly Pay

    Nurse Aide - Earn $1,000 Weekly Pay

    Wilson Care GroupWaianae, 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 moreLast updated: 30+ days ago
    • Promoted
    Home Health Aide - Earn $1,000 weekly pay

    Home Health Aide - Earn $1,000 weekly pay

    Wilson Care GroupWaianae, 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 moreLast updated: 30+ days ago
    • Promoted
    Home Health Aide - $16-$22 Hourly pay

    Home Health Aide - $16-$22 Hourly pay

    Wilson Care GroupWaianae, 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 moreLast updated: 30+ days ago
    • Promoted
    Travel Nurse RN - Home Health - $61 per hour in Kaneohe, HI

    Travel Nurse RN - Home Health - $61 per hour in Kaneohe, HI

    TravelNurseSourceKaneohe, HI, US
    Full-time
    TravelNurseSource is working with Adelphi Medical Staffing to find a qualified Home Health RN in Kaneohe, Hawaii, 96744!. Shift Schedule : 8 hrs per day;.Weekend Requirements : Rotating Weekends as ne...Show moreLast updated: 23 days ago
    • Promoted
    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Syneos Health / inVentiv Health Commercial LLCHonolulu, 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 moreLast updated: 9 days ago
    • Promoted
    Home Health Aide - Wilson Care Group

    Home Health Aide - Wilson Care Group

    Wilson Care GroupWaianae, 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 moreLast updated: 30+ days ago