Serve as a subject matter expert; and as the medical writing lead on complex writing assignments within and across departmental team(s) on document strategies.
Lead project team meetings and document review meetings, follow up on actions, and provide direction and solutions to cross-functional teams on expectations for document content.
Adhere to established regulatory standards, as well as company Standard Operating Procedures (SOPs), client standards, and company approved templates when completing medical writing projects, on-time and on-budget.
Write, edit, and finalize clinical and nonclinical publications, manuscripts, journal abstracts, congress materials, educational/training materials, and other external-facing documents.
Serve as peer reviewer providing review comments to give maximum clarity of meaning, accuracy, relevance and to ensure that medical communications objectives are met.
Ensure that all publication activities are of high scientific and medical quality and meet Good Publication Practices standards, align with SOPs and are documented appropriately.
Manage the development and execution of a “rolling” strategic publication plan for clinical and real-world evidence (RWE) studies, ensuring alignment with the medical and clinical development strategy and adhering to industry best practices (e.g., GPP, ICMJE, PRISMA, CONSORT, etc.).
Lead the development, review, editorial, approval, and submission of manuscripts, abstracts, posters, and presentations across clinical trials, real-world evidence studies, and health economics outcomes research (HEOR).
Requirements
Bachelor’s degree in science-related fields with 10+ years of relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, publications, clinical research, or product support/R&D experience is required;
or Master’s degree in science-related fields with 8+ years of relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, publications, clinical research, or product support/R&D experience is required;
or Doctorates’ degree or equivalent in science-related fields with 6+ years of relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, publications, clinical research, or product support/R&D experience is required.
Strong expertise in clinical trial and RWE (Real World Evidence) publications, including phases l-lV, observational studies, registry data, and HEOR (Health Economics and Outcomes Research) required.
Proven track record of leading publication strategies, delivering peer-reviewed publications, and congress presentations required.
Experience in scientific writing, editing, and communicating complex data to diverse audiences.
Experience writing scientific medical publications such as journal manuscripts, abstracts, and congress materials required
Strong scientific background in oncology, immunotherapy, or related field is required.
CMPP (Certified Medical Publications Professional) or AMWA (American Medical Writers Association) Certification is preferred.
Proficiency with publication and reference management systems (e.g., iEnvision, EndNote, Mendeley, Zotero, PubMed or similar).
Benefits
Medical, Dental and Vision Plan Options
Health and Financial Wellness Programs
Employer Assistance Program (EAP)
Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
Healthcare and Dependent Care Flexible Spending Accounts
401(k) Retirement Plan with Company Match
529 Education Savings Program
Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
Paid Time Off (PTO) includes: 11 Holidays
Exempt Employees are eligible for Unlimited PTO
Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
medical writingscientific writingeditingclinical trial publicationsreal world evidence (RWE)health economics outcomes research (HEOR)publication strategiespeer-reviewed publicationscongress presentationsdata communication
Soft skills
leadershipproject managementcommunicationcollaborationattention to detailproblem-solvingstrategic planningpeer reviewdirection providingclarity of meaning
Certifications
CMPP (Certified Medical Publications Professional)AMWA (American Medical Writers Association) Certification