Talent.com
Principal Medical Writer

Principal Medical Writer

Syneos Health / inVentiv Health Commercial LLCVirginia Beach, VA, United States
11 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 • Virginia Beach, VA, United States

    Related jobs
    • Promoted
    Principal Regulatory Writer

    Principal Regulatory Writer

    VirtualVocationsPortsmouth, Virginia, United States
    Full-time
    A company is looking for a Principal Regulatory Writer with a NonClinical focus.Key Responsibilities Lead the development of strategies and prepare regulatory documents in collaboration with clie...Show moreLast updated: 3 days ago
    • Promoted
    Senior Pharma Report Writer

    Senior Pharma Report Writer

    VirtualVocationsNewport News, Virginia, United States
    Full-time
    A company is looking for a Qualitative Senior Pharma Report Writer (temporary role, full-time hours).Key Responsibilities Independently manage multiple global qualitative research projects in the...Show moreLast updated: 3 days ago
    • Promoted
    Physician (MD / DO) - Family Practice in Eastville, VA

    Physician (MD / DO) - Family Practice in Eastville, VA

    LocumJobsOnlineEastville, VA, US
    Full-time +2
    LocumJobsOnline is working with CompHealth to find a qualified Family Practice MD in Eastville, Virginia, 23347!.Whether you are searching for a position in your area or in another state, we have p...Show moreLast updated: 30+ days ago
    • Promoted
    Family Practice

    Family Practice

    CompHealthEastville, Virginia, US
    Full-time
    Family Practice physician employment in Virginia : Whether you are searching for a position in your area or in another state, we have professionals to help you achieve your goals through our relati...Show moreLast updated: 24 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 LLCVirginia Beach, VA, 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: 5 days ago
    • Promoted
    Information Technology Professional

    Information Technology Professional

    U.S. NavySeaford, VA, United States
    Full-time +1
    To be eligible to enlist in the U.Navy, candidates must be between the ages of 18-34.At any given moment, hundreds of complex networked computer systems are operating in tandem to keep ships and su...Show moreLast updated: 30+ days ago
    • Promoted
    Search & Rescue

    Search & Rescue

    U.S. NavySeaford, VA, United States
    Full-time +1
    To be eligible to enlist in the U.Navy, candidates must be between the ages of 18-34.When lives are on the line, Navy Aviation Rescue Swimmers (AIRRs) are exceptionally adept at answering the call....Show moreLast updated: 30+ days ago
    • Promoted
    Sr Medical Writer (Regulatory Documents)

    Sr Medical Writer (Regulatory Documents)

    Syneos Health / inVentiv Health Commercial LLCVirginia Beach, VA, United States
    Full-time
    Sr Medical Writer (Regulatory Documents).Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medi...Show moreLast updated: 7 days ago
    • Promoted
    Med-Ped

    Med-Ped

    Enterprise Medical RecruitingChesapeake, Virginia, US
    Full-time
    Med-Ped physician employment in Virginia : .This primary care group that was founded in 1991 is adding Med / Ped physicians to its team of 120 primarycare physicians. This opportunity is located in Che...Show moreLast updated: 24 days ago
    • Promoted
    Travel Medical Assistant (MA) - $23 to $26 per hour in Glen Allen, VA

    Travel Medical Assistant (MA) - $23 to $26 per hour in Glen Allen, VA

    AlliedTravelCareersChesapeake, Virginia, US
    Full-time
    AlliedTravelCareers is working with All Medical Personnel to find a qualified Medical Assistant in Glen Allen, Virginia, 23059!. Position : Medical Assistant- PRN / FLOAT.Schedule, confirm patient appo...Show moreLast updated: 10 days ago
    • Promoted
    Locum Physician (MD / DO) - Emergency Medicine in Newport News, VA

    Locum Physician (MD / DO) - Emergency Medicine in Newport News, VA

    LocumJobsOnlineChesapeake, Virginia, US
    Full-time
    LocumJobsOnline is working with CompHealth to find a qualified Emergency Medicine MD in Newport News, Virginia, 23606!.CompHealth exists to make the locums process easier.Not only will we search fo...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Medical Writer

    Senior Medical Writer

    VirtualVocationsNorfolk, Virginia, United States
    Full-time
    A company is looking for a Senior Medical Writer to lead the development and execution of medical writing strategies for clinical research projects. Key Responsibilities Lead the preparation, revi...Show moreLast updated: 30+ days ago
    • Promoted
    Registered Nurse

    Registered Nurse

    U.S. NavySeaford, VA, United States
    Full-time +1
    To be eligible to enlist in the U.Navy, candidates must be between the ages of 18-34.The greatest reward for nearly every nurse is the joy of serving others. But in the Navy Nurse Corps, when you wo...Show moreLast updated: 30+ days ago
    • Promoted
    Naval Aviator

    Naval Aviator

    U.S. NavySeaford, VA, United States
    Full-time +1
    To be eligible to enlist in the U.Navy, candidates must be between the ages of 18-34.Navy operates more than 3,700 aircraft, making it the second largest air force in the world second only to the U...Show moreLast updated: 30+ days ago
    • Promoted
    Medical Writer

    Medical Writer

    VirtualVocationsChesapeake, Virginia, United States
    Full-time
    A company is looking for a Medical Writer, encouraging recent PhD candidates to apply.Key Responsibilities Produce high-quality content for various medical communications projects, demonstrating ...Show moreLast 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 LLCVirginia Beach, VA, 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: 4 days ago
    • Promoted
    Principal / Senior Medical Writer - Regulatory - Oncology - North America / United Kingdom and Ireland (homebased)

    Principal / Senior Medical Writer - Regulatory - Oncology - North America / United Kingdom and Ireland (homebased)

    Syneos Health / inVentiv Health Commercial LLCVirginia Beach, VA, United States
    Full-time
    Principal / Senior Medical Writer - Regulatory - Oncology - North America / United Kingdom and Ireland (homebased).Syneos Health is a leading fully integrated biopharmaceutical solutions organization b...Show moreLast updated: 4 days ago
    • Promoted
    NEXWDC Doctrine Writer

    NEXWDC Doctrine Writer

    PrevailanceVirginia Beach, VA, US
    Full-time
    This position is currently filled, however we are accepting applications for Ready Replacement Pool consideration.A subject matter expert (SME), working with a collaborative team, to analyze and ev...Show moreLast updated: 30+ days ago