Talent.com
Principal Medical Writer Global Medical Writing Job at Deciphera Pharmaceuticals
Principal Medical Writer Global Medical Writing Job at Deciphera PharmaceuticalsMediabistro • Waltham, MA, United States
Principal Medical Writer Global Medical Writing Job at Deciphera Pharmaceuticals

Principal Medical Writer Global Medical Writing Job at Deciphera Pharmaceuticals

Mediabistro • Waltham, MA, United States
job_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

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 that continuously evolves with new regulations and technologies. The role provides the ability to influence company leaders and work on exciting fast-paced drug development programs. This is your chance to join a dynamic Medical Writing team and be part of an emerging success story driven by the company's unwavering commitment to patients and employees.

The Role :

The Medical Writing team is looking for an experienced, self-motivated individual knowledgeable of the current MW landscape to serve as Principal Medical Writer. The individual will be the lead writer across programs / submissions that are part of the growing clinical pipeline.

In this high visibility role, the individual will be responsible for independently writing and managing clinical study-related documents including, but not limited to, clinical study protocols, master protocols, Investigator's brochures, and clinical study reports. The individual will lead cross-functional teams in development of regulatory submission documents, regulatory response documents, and other IND / CTA or global regulatory submission documents.

The position reports to the Sr. Director, Global Medical Writing.

What You'll Do :

  • Medical Writing lead for one or more clinical programs, leading the planning, development, and implementation of content strategy for clinical and regulatory documents

Represent Medical Writing on cross-functional clinical, regulatory, and submission teams and actively participate in NDA / MAA / IND submission planning and documentation

  • Author and manage the preparation of clinical documents and other assigned tasks within established timelines with the highest quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes
  • Drive document strategies and messages in a collaborative way with relevant project team subject matter experts
  • Maintain cutting edge knowledge base of current developments in field and related technologies.
  • Incorporate process improvements and changes that align with R&D needs
  • Excellent written communication skills, detailed-oriented, self-directed and with the ability to be flexible and manage workload of multiple concurrent projects to meet project timelines
  • Plan and coordinate work with in-house Medical Writer team and outside CROs
  • Mentor junior members of the team, providing guidance and expertise in medical writing
  • Strong team player and a change agent who further reinforces / enhances Deciphera's cultural values
  • Experienced and skilled in performing medical literature searches
  • Perform reviews of medical writing deliverables, as well as reviews of statistical analysis plans, tables, figures, and listings, as needed
  • Qualifications

  • Advanced degree (MS or Ph.D.) in a relevant scientific field. Ph.D. degree is preferred
  • Minimum of 5-8 years medical writing experience
  • Expert knowledge of and experience in preparing high quality clinical and regulatory documents
  • Knowledge of clinical trial disclosure
  • Submission experience across ICH regions (NDA, NDS, MAA, IND) with active contribution in preparation of summary documents
  • Excellent verbal and written communication skills and attention to detail related to consistency, grammar, syntax, and accuracy
  • Strong organizational / prioritization skills for the management of multiple concurrent documents
  • Demonstrated proficiency with eCTD Starting Point templates, Smart Sheet, databases, presentation software (MS Office skills such as Teams, Outlook, Word, Excel, PowerPoint, and SharePoint), Veeva Vault, and Please Review
  • Oncology, immunology, and / or neurology experience is highly preferred
  • Additional Information

    Benefits :

  • Competitive salary and annual bonus.
  • Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
  • Generous parental leave and family planning benefits.
  • Outstanding culture and opportunities for personal and professional growth.
  • Apply Now : Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!

    EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

    Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.

    #J-18808-Ljbffr

    serp_jobs.job_alerts.create_a_job

    Medical Writer • Waltham, MA, United States

    Job_description.internal_linking.related_jobs
    Parexel is hiring : Principal Medical Writer- FSP in Boston

    Parexel is hiring : Principal Medical Writer- FSP in Boston

    Mediabistro • Boston, 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_more
    serp_jobs.last_updated.last_updated_variable_days
    Medical Writer Job at Redbock - an NES Fircroft company in Boston

    Medical Writer Job at Redbock - an NES Fircroft company in Boston

    Mediabistro • Boston, MA, United States
    serp_jobs.job_card.full_time
    A leading global manufacturer of cardiovascular medical devices is in immediate need of a remote Medical Writer consultant to support them until 3 / 31 / 2026. This is a 40 hours / week position.The Manag...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days
    Senior Director, Medical Writing (Hybrid)

    Senior Director, Medical Writing (Hybrid)

    Vertex Pharmaceuticals • Boston, MA, United States
    serp_jobs.job_card.full_time
    Senior Director, Medical Writing (Hybrid).Senior Director, Medical Writing (Hybrid).Senior Director, Medical Writing (Hybrid). Be among the first 25 applicants.Senior Director, Medical Writing (Hybr...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Apex Systems is hiring : Medical Writer in Cambridge

    Apex Systems is hiring : Medical Writer in Cambridge

    Mediabistro • Cambridge, MA, United States
    serp_jobs.job_card.part_time
    Job Description# Medical Writer • •Location • • : Cambridge, MA (Hybrid) • •Job Overview : • • This role is for a skilled Medical Writer to create and refine essential documents for clinical studies and regu...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30
    Principal Medical Writer Job at Synterex Inc in Boston

    Principal Medical Writer Job at Synterex Inc in Boston

    Mediabistro • Boston, 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_more
    serp_jobs.last_updated.last_updated_30
    Synterex is hiring : Principal Medical Writer in Boston

    Synterex is hiring : Principal Medical Writer in Boston

    Mediabistro • Boston, 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_more
    serp_jobs.last_updated.last_updated_30
    Senior Director, Medical Writing (Hybrid) Job at Vertex Pharmaceuticals Incorpor

    Senior Director, Medical Writing (Hybrid) Job at Vertex Pharmaceuticals Incorpor

    Mediabistro • Boston, MA, United States
    serp_jobs.job_card.full_time
    Our Medical Writing function at Vertex is in-house, and our Writers are strategic partners in our drug development process, collaborating with cross functional teams to bring innovative new therapi...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days
    Senior Medical Writer Job at Synterex in Boston

    Senior Medical Writer Job at Synterex in Boston

    Mediabistro • Boston, 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_more
    serp_jobs.last_updated.last_updated_30
    Actalent is hiring : Sr. Medical Writer in Lexington

    Actalent is hiring : Sr. Medical Writer in Lexington

    Mediabistro • Lexington, MA, United States
    serp_jobs.job_card.full_time
    This role involves the review and preparation of clinical and regulatory documents to ensure compliance with regulatory requirements. The position is responsible for writing a variety of document ty...serp_jobs.internal_linking.show_more
    serp_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

    Mediabistro • Waltham, MA, United States
    serp_jobs.job_card.full_time
    Principal Medical Writer, Global Medical Writing.Principal Medical Writer, Global Medical Writing.This is an exciting leadership opportunity for a person with passion and talent.The company believe...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30
    Medical Writer Job at Synterex Inc in Boston

    Medical Writer Job at Synterex Inc in Boston

    Mediabistro • Boston, 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_more
    serp_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

    Mediabistro • Waltham, 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_more
    serp_jobs.last_updated.last_updated_30
    Redbock - an NES Fircroft company is hiring : Medical Writer in Boston

    Redbock - an NES Fircroft company is hiring : Medical Writer in Boston

    Mediabistro • Boston, MA, United States
    serp_jobs.job_card.full_time
    A leading global manufacturer of cardiovascular medical devices is in immediate need of a remote.This is a 40 hours / week position. The Manager, along with most of the Medical Writing team, is based ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days
    Deciphera Pharmaceuticals is hiring : Principal Medical Writer Global Medical Wri

    Deciphera Pharmaceuticals is hiring : Principal Medical Writer Global Medical Wri

    Mediabistro • Waltham, 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_more
    serp_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

    Mediabistro • Boston, MA, United States
    serp_jobs.job_card.full_time
    Principal Medical Writer - Regulatory and Medical Writing Join to apply for the Principal Medical Writer - Regulatory and Medical Writing role at Ionis Pharmaceuticals, Inc.Principal Medical Wr...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30
    Principal Medical Writer

    Principal Medical Writer

    Synterex • Dedham, 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_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Principal Medical Writer Job at Vor Bio in Boston

    Principal Medical Writer Job at Vor Bio in Boston

    Mediabistro • Boston, MA, United States
    serp_jobs.job_card.full_time
    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 of disease. By advancing telitacicept, a first- and potentiall...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30
    Vor Bio is hiring : Principal Medical Writer in Boston

    Vor Bio is hiring : Principal Medical Writer in Boston

    Mediabistro • Boston, 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_more
    serp_jobs.last_updated.last_updated_30