Medical Writer, Recent PhD Candidates Encouraged to Apply
Lumanity
Principal Medical Writer, Global Medical Writing
Deciphera Pharmaceuticals
full-time
Posted on:
Location Type: Remote
Location: Remote • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $164,000 - $226,000 per year
Job Level
Lead
Tech Stack
Vault
About the role
- 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
Requirements
- PhD or equivalent plus 5+ years of experience or Bachelors/Masters plus 10+ years of 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,
- Oncology, immunology, and/or neurology experience is highly preferred
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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
medical writingclinical documents preparationregulatory documents preparationclinical trial disclosuresubmission experienceeCTD Starting Point templatesmedical literature searchesstatistical analysis plans reviewattention to detailproject management
Soft skills
written communicationorganizational skillsprioritization skillsflexibilityteam playermentoringself-directedcollaborationchange agentdetail-oriented
Certifications
PhDMastersBachelors
