Top 5193 Writer Jobs | SimplyHired

Medical Writer
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Sr. Principal Medical Writer - Regulatory Submission Docs (ISE/ISS/Clinical Overview - Must Have) - Oncology Preferred
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Medical Writer

Smart-tek -
Remote

Quick Apply

Job Details

Part-time | Contract
$75 - $120 an hour
9 days ago

Qualifications

Microsoft Word
Medical writing
Teamwork
Master's degree
Attention to detail
Quality control

Full Job Description

Contract Medical Writer – NDA Submission Support

Location: Remote
Start Date: ASAP
Contract Duration: 4 months with potential for extension
Hours: likely averaging 10–20 hours weekly
Product Focus: Oncology imaging agent

We are seeking an experienced Contract Medical Writer to support medical writing activities related to NDA submission packages. This role will focus on clinical/regulatory documentation, including Clinical Study Reports (CSRs), Module 2 overviews, and other submission-related documents. The ideal candidate will have strong sponsor-level medical writing experience, excellent attention to detail, and the ability to work independently in a fast-paced, cross-functional environment.

Key Responsibilities

Author and support medical writing content, including clinical protocols and amendments, Investigator Brochures, Clinical Study Reports, agency responses, IND/CTA submission documents, NDA/MAA clinical modules, summary documents, and other clinical/regulatory writing as needed.
Support medical writing activities associated with NDA submission packages, including CSRs and Module 2 clinical overviews.
Collaborate closely with Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, CMC, Project Management, and other cross-functional teams.
Partner with internal and external writers as needed to support document completion.
Manage document preparation from start to finish, including kickoff planning, drafting, review cycle management, revisions, quality control/quality assurance comments, and finalization within timelines.
Ensure clarity, consistency, accuracy, and proper formatting of clinical and regulatory documents.
Maintain compliance with GCP, ICH, CTD/eCTD, and company guidelines.
Interpret complex clinical data and scientific information.
Demonstrate strategic thinking and strong document review capabilities.
Contribute to the improvement of SOPs, templates, and document standards.

Qualifications

Advanced degree required; PhD, PharmD, or Master’s degree in a scientific, clinical, or English-related discipline preferred.
4+ years of medical writing or relevant pharmaceutical industry experience.
Minimum of 2 years of sponsor-level clinical/regulatory medical writing experience.
NDA submission experience strongly preferred.
Experience writing CSRs and Module 2 summaries/overviews strongly preferred.
Previous neuroscience experience is strongly preferred; oncology experience is a plus.
Strong understanding of drug development, biostatistics, medical terminology, and scientific methodology as applied to clinical development.
Knowledge of global clinical trial and regulatory submission requirements, including FDA, EMA, PMDA, ICH, GCP, CTD/eCTD, and EU privacy/redaction regulations.
Advanced Microsoft Word skills, including formatting, styles, templates, tables, references, and tracked changes.
Familiarity with document management and collaborative authoring platforms such as Veeva Vault and PleaseReview.
Strong organizational, communication, and influencing skills.
Ability to prioritize, multitask, and deliver high-quality documents under tight timelines.
Highly accurate, detail-oriented, professional, and diplomatic.
Ability to work independently and collaboratively with cross-functional teams.

Apply Today

Qualified medical writers with strong clinical/regulatory writing experience and availability to support part-time NDA submission work are encouraged to apply. #INDHP

Pay: $75.00 - $120.00 per hour

Application Question(s):

Do you have at least 2 years of sponsor-level clinical/regulatory medical writing experience?
Have you written or substantially contributed to NDA submission documents, including Clinical Study Reports and/or Module 2 clinical summaries or overviews?
Please describe your experience writing CSRs, Module 2 documents, IND/CTA documents, Investigator Brochures, or clinical protocols.
Do you have experience supporting FDA, EMA, PMDA, or other global regulatory submissions using ICH, GCP, CTD/eCTD standards?
Are you available to start ASAP for a 4-month contract averaging approximately 10–15 hours per week, with the possibility of up to 30 hours depending on workload?

Work Location: Remote

Quick Apply

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