Talent.com
serp_jobs.error_messages.no_longer_accepting
Principal Medical Writer

Principal Medical Writer

Syneos Health / inVentiv Health Commercial LLCBoston, MA, United States
job_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.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.

    serp_jobs.job_alerts.create_a_job

    Medical Writer • Boston, MA, United States

    Job_description.internal_linking.related_jobs
    • serp_jobs.job_card.promoted
    Strategic Proposal Writer

    Strategic Proposal Writer

    VirtualVocationsDorchester, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Strategic Proposal Writer to create compelling proposals that effectively position their offerings in the healthcare market. Key Responsibilities : Articulate the value p...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    Parexel is hiring : Principal Medical Writer- FSP in Boston

    Parexel is hiring : Principal Medical Writer- FSP in Boston

    MediabistroBoston, MA, United States
    serp_jobs.job_card.full_time
    Parexel FSP is looking for a Principal Medical Writer! This is a remote role anywhere in the United States or Canada.The Medical Writer, Medical Writing, is responsible for writing and overseeing t...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    Senior Medical Writer

    Senior Medical Writer

    Costello MedicalBoston, MA, US
    serp_jobs.job_card.full_time +1
    serp_jobs.filters_job_card.quick_apply
    You will take a leading role across a variety of medical communication projects, working alongside a team of excellent colleagues to ensure that projects are delivered to an exceptionally high stan...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    Principal Medical Writer Job at Synterex Inc in Boston

    Principal Medical Writer Job at Synterex Inc in Boston

    MediabistroBoston, MA, United States
    serp_jobs.job_card.full_time
    Synterex offers remote or on-site services, with a focus on providing clear, concise, accurate, and fully compliant documentation, from early drug development through post-approval.Synterex is seek...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    Synterex is hiring : Principal Medical Writer in Boston

    Synterex is hiring : Principal Medical Writer in Boston

    MediabistroBoston, MA, United States
    serp_jobs.job_card.full_time
    Synterex offers remote or on-site services, with a focus on providing clear, concise, accurate, and fully compliant documentation, from early drug development through post-approval.Synterex is seek...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    Principal Medical Writer Global Medical Writing Job at Deciphera Pharmaceuticals

    Principal Medical Writer Global Medical Writing Job at Deciphera Pharmaceuticals

    MediabistroWaltham, MA, United States
    serp_jobs.job_card.full_time
    This is an exciting leadership opportunity for a person with passion and talent.The company believes that medical writing is a science that continuously evolves with new regulations and technologie...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    Senior Medical Writer (Remote)

    Senior Medical Writer (Remote)

    MMSBoston, MA, US
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    serp_jobs.filters_job_card.quick_apply
    About MMS MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory sub...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Principal Medical Writer

    Principal Medical Writer

    Syneos Health / inVentiv Health Commercial LLCBoston, MA, United States
    serp_jobs.job_card.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 ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Global Medical Writing Director

    Global Medical Writing Director

    VirtualVocationsLowell, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for an Associate Director, Global Medical Writing (Publications).Key Responsibilities Draft, revise, and edit scientific publications, including manuscripts, abstracts, poste...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Syneos Health / inVentiv Health Commercial LLCBoston, MA, United States
    serp_jobs.job_card.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...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.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 LLCBoston, MA, United States
    serp_jobs.job_card.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 ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    Principal Medical Writer, Global Medical Writing Job at Deciphera Pharmaceutical

    Principal Medical Writer, Global Medical Writing Job at Deciphera Pharmaceutical

    MediabistroWaltham, MA, United States
    serp_jobs.job_card.full_time
    Principal Medical Writer, Global Medical Writing Join to apply for the Principal Medical Writer, Global Medical Writing role at Deciphera Pharmaceuticals. What’s In It for You This is an exciting...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    Principal Medical Writer, Global Medical Writing Job at Deciphera Pharma in Walt

    Principal Medical Writer, Global Medical Writing Job at Deciphera Pharma in Walt

    MediabistroWaltham, MA, United States
    serp_jobs.job_card.full_time
    Job Description What’s In It for You : This is an exciting leadership opportunity for a person with passion and talent.The company believes that medical writing is a science that continuously evolve...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    Kiniksa Pharmaceuticals is hiring : Principal Medical Writer in Lexington

    Kiniksa Pharmaceuticals is hiring : Principal Medical Writer in Lexington

    MediabistroLexington, MA, United States
    serp_jobs.job_card.full_time
    Director, Medical Writing, the Principal Medical Writer is responsible for researching, planning, writing, and editing medical writing deliverables that support clinical development and regulatory ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    Deciphera Pharmaceuticals is hiring : Principal Medical Writer Global Medical Wri

    Deciphera Pharmaceuticals is hiring : Principal Medical Writer Global Medical Wri

    MediabistroWaltham, MA, United States
    serp_jobs.job_card.full_time
    Company Description Job Description What's In It for You : This is an exciting leadership opportunity for a person with passion and talent. The company believes that medical writing is a science t...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    Principal Medical Writer - Regulatory and Medical Writing Job at Ionis Pharmaceu

    Principal Medical Writer - Regulatory and Medical Writing Job at Ionis Pharmaceu

    MediabistroBoston, MA, United States
    serp_jobs.job_card.full_time
    Principal Medical Writer - Regulatory and Medical Writing.Principal Medical Writer - Regulatory and Medical Writing.Principal Medical Writer - Regulatory and Medical Writing.Principal Medical Write...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Principal Medical Writer

    Principal Medical Writer

    SynterexDedham, MA, US
    serp_jobs.job_card.full_time
    Synterex offers remote or on-site services, with a focus on providing clear, concise, accurate, and fully compliant documentation, from early drug development through post-approval.Synterex is seek...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    Principal Medical Writer Job at Vor Bio in Boston

    Principal Medical Writer Job at Vor Bio in Boston

    MediabistroBoston, MA, United States
    serp_jobs.job_card.full_time
    Get AI-powered advice on this job and more exclusive features.Join Us in Tackling Autoimmune Disease at Its Root.At Vor, we believe science can do more than manage symptoms.It can change the course...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    Vor Bio is hiring : Principal Medical Writer in Boston

    Vor Bio is hiring : Principal Medical Writer in Boston

    MediabistroBoston, MA, United States
    serp_jobs.job_card.full_time
    Join to apply for the Principal Medical Writer role at Vor Bio Get AI-powered advice on this job and more exclusive features. Join Us in Tackling Autoimmune Disease at Its Root At Vor, we believe...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    Associate Director-Principal Medical Writer Job at Sanofi in Boston

    Associate Director-Principal Medical Writer Job at Sanofi in Boston

    MediabistroBoston, MA, United States
    serp_jobs.job_card.full_time
    Job Title : • • Associate Director-Principal Medical Writer • •Location : • • USA, Remote.Proximity to Cambridge / Boston, MA or Morristown, NJ is highly desirable for attending occasional team meetings • •Abo...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30