CPT Senior Medical Writer Jobs
Senior Medical Writer roles in pharma, biotech, and CROs involve drafting clinical study reports, regulatory submissions, and investigator brochures, work that maps directly to graduate programs in life sciences, pharmacy, or regulatory affairs. Your DSO must authorize CPT before your start date, and the role must be listed as integral to your degree plan.
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Get Access To All JobsAbout BOSTONGENE: BostonGene is redefining cancer patient care and drug development through the integration of omnimodal data and artificial intelligence. Built and validated through an extensive real-world clinical testing network, BostonGene’s Foundation Model of cancer and the immune system integrates genomic, transcriptomic, and immune data with clinical outcomes to generate biologically grounded, actionable insights. These insights enable biopharma partners to design and de-risk trials, identify novel targets, and optimize therapeutic response prediction across all stages of development while simultaneously improving patient care through clinically integrated innovation.
Position Overview
BostonGene is seeking a bench Scientist to join our R&D next-generation sequencing (NGS) team in our laboratory located in Waltham, MA. This candidate will support assay development and technical transfer in collaboration with immunology, production, and bioinformatics teams. The candidate will be expected to support NGS protocols, such as RNA and DNA isolation from tissue, cell-free DNA isolation from plasma, library preparation, QC, and other lab processes. The role will primarily require laboratory bench work (70-80%) in a BSL-2 laboratory.
Key Responsibilities:
- Perform assay and product development experiments of NGS workflows, including WGS, WES, and liquid biopsy assays for internal and external collaborators
- Troubleshoot and support the technical transfer of workflows to the production lab
- Maintain detailed and accurate records in LIMS, ELN, and in compliance with laboratory protocols and regulatory requirements
- Assist in the development of laboratory SOPs and batch records
- Execute and assist with validation studies, bridging studies, and technical reports
- Stay informed on emerging technologies and trends in NGS to support innovation in assay development
Qualifications
- Ph.D. in life sciences or related discipline with 0–3 years of relevant experience, OR M.S. with 3–6 years, OR B.S. with 6–10 years of hands-on experience. (The job title will be commensurate with experience.)
- Strong experience in nucleic acid extraction (DNA/RNA) from FFPE, blood, or other clinical samples
- Proficiency in NGS library prep (short-read and/or long-read), including WGS and WES
- Excellent problem-solving and troubleshooting skills
- Strong organizational skills with the ability to manage sample tracking, documentation, and inventory
Preferred Skills & Experience:
- Experience working with liquid biopsy samples (cfDNA/ctDNA, cfRNA, or exosomes)
- Familiarity with NGS QC metrics and analysis tools
- Understanding of assay validation in regulated environments (GCLP, ISO)
- Demonstrated experience in SOP development and process documentation
- Strong verbal and written communication skills, with the ability to work effectively in cross-functional teams
- Proven ability to work in a dynamic, fast-paced environment with shifting priorities
- Self-motivated and accountable, with a collaborative mindset
Additional Information
- Ability to stand for prolonged periods and perform repetitive tasks inherent to laboratory work.
About BOSTONGENE: BostonGene is redefining cancer patient care and drug development through the integration of omnimodal data and artificial intelligence. Built and validated through an extensive real-world clinical testing network, BostonGene’s Foundation Model of cancer and the immune system integrates genomic, transcriptomic, and immune data with clinical outcomes to generate biologically grounded, actionable insights. These insights enable biopharma partners to design and de-risk trials, identify novel targets, and optimize therapeutic response prediction across all stages of development while simultaneously improving patient care through clinically integrated innovation.
Position Overview
BostonGene is seeking a bench Scientist to join our R&D next-generation sequencing (NGS) team in our laboratory located in Waltham, MA. This candidate will support assay development and technical transfer in collaboration with immunology, production, and bioinformatics teams. The candidate will be expected to support NGS protocols, such as RNA and DNA isolation from tissue, cell-free DNA isolation from plasma, library preparation, QC, and other lab processes. The role will primarily require laboratory bench work (70-80%) in a BSL-2 laboratory.
Key Responsibilities:
- Perform assay and product development experiments of NGS workflows, including WGS, WES, and liquid biopsy assays for internal and external collaborators
- Troubleshoot and support the technical transfer of workflows to the production lab
- Maintain detailed and accurate records in LIMS, ELN, and in compliance with laboratory protocols and regulatory requirements
- Assist in the development of laboratory SOPs and batch records
- Execute and assist with validation studies, bridging studies, and technical reports
- Stay informed on emerging technologies and trends in NGS to support innovation in assay development
Qualifications
- Ph.D. in life sciences or related discipline with 0–3 years of relevant experience, OR M.S. with 3–6 years, OR B.S. with 6–10 years of hands-on experience. (The job title will be commensurate with experience.)
- Strong experience in nucleic acid extraction (DNA/RNA) from FFPE, blood, or other clinical samples
- Proficiency in NGS library prep (short-read and/or long-read), including WGS and WES
- Excellent problem-solving and troubleshooting skills
- Strong organizational skills with the ability to manage sample tracking, documentation, and inventory
Preferred Skills & Experience:
- Experience working with liquid biopsy samples (cfDNA/ctDNA, cfRNA, or exosomes)
- Familiarity with NGS QC metrics and analysis tools
- Understanding of assay validation in regulated environments (GCLP, ISO)
- Demonstrated experience in SOP development and process documentation
- Strong verbal and written communication skills, with the ability to work effectively in cross-functional teams
- Proven ability to work in a dynamic, fast-paced environment with shifting priorities
- Self-motivated and accountable, with a collaborative mindset
Additional Information
- Ability to stand for prolonged periods and perform repetitive tasks inherent to laboratory work.
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Get Access To All JobsSenior Medical Writer CPT: Frequently Asked Questions
Does a Senior Medical Writer role qualify for CPT authorization?
Yes, if your degree program includes coursework in regulatory affairs, clinical research, pharmacology, or scientific communication. Your DSO must confirm the position is integral to your curriculum, not just related to your field. Bring the full job description to your advisor, since roles focused on commercial or marketing writing may not qualify even at the same company.
Can I work remotely as a Senior Medical Writer on CPT?
Remote work is generally permitted on CPT, but your CPT authorization lists a specific employer and work site. If the role is fully remote, your I-20 may list your home address or the company's principal office. Confirm with your DSO how your school handles remote site designation, since some schools require a physical address associated with the employer.
How do I find Senior Medical Writer jobs that accept CPT students?
Search Migrate Mate for Senior Medical Writer openings filtered by employers with visa sponsorship history. CROs, mid-size pharma companies, and medical communications agencies are the most common CPT hosts for this role. Larger pharma firms sometimes restrict CPT to students from partner universities, so smaller CROs and med comms agencies are often more accessible entry points.
What happens to my OPT eligibility if I use full-time CPT for this role?
Full-time CPT used for 12 months or more eliminates your OPT eligibility entirely. Part-time CPT, defined as 20 hours or fewer per week, has no effect on OPT regardless of duration. If you're considering a 12-month full-time placement at a CRO or pharma company, weigh that against your post-graduation plans before your DSO submits the authorization.
Do I need any certifications to secure a Senior Medical Writer CPT placement?
No certification is required by USCIS or DOL for CPT authorization, but employers hiring at the senior level typically expect demonstrated familiarity with ICH guidelines, Good Clinical Practice, and regulatory submission formats like CTD or eCTD. A graduate-level course in regulatory writing or a clinical research methods course strengthens your application and makes your DSO's integral-curriculum argument easier to document.
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