Senior Medical Writer II
EPM Scientific, California, MO, United States
Senior Medical Writer II
Company Overview
A privately held biopharmaceutical company is leveraging innovative technologies at the intersection of chemistry, engineering, computation, and biology to advance the discovery of novel therapies for serious and life‑threatening diseases. The organization operates in a highly collaborative, fast‑paced environment and is focused on translating cutting‑edge science into meaningful clinical impact.
Position Summary
The Senior Medical Writer II plays a key role in translating complex scientific and medical information into clear, accurate, and high‑quality written materials. This individual will contribute to a broad range of documents supporting research, clinical development, and regulatory activities, working closely with cross‑functional teams across the organization.
About the Ideal Candidate
The ideal candidate is a strong scientific communicator with exceptional attention to detail and the ability to clearly convey complex concepts to diverse audiences. This role requires comfort working independently, managing multiple priorities, and collaborating in a dynamic environment. Experience with clinical research and regulatory documentation is highly valued.
Key Responsibilities
Document Development:
Author and support the preparation of a variety of medical and scientific documents, including clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), informed consent forms (ICFs), regulatory submissions, and scientific publications.
Cross‑Functional Collaboration:
Partner with clinical, regulatory, and scientific teams to gather, interpret, and accurately present data.
Regulatory Compliance:
Ensure all documents comply with applicable regulatory guidelines, industry standards, and internal quality requirements.
Literature Review:
Conduct comprehensive literature searches and synthesize findings to support evidence‑based content development.
Data Interpretation:
Summarize complex scientific and clinical data clearly for both technical and non‑technical audiences.
Editing & Quality Control:
Review and edit documents for clarity, consistency, grammar, and scientific accuracy.
Mentorship:
Provide guidance and support to junior medical writers, contributing to their professional development.
Qualifications
PhD with 3+ years of relevant experience,
or
Master's degree with 6+ years of experience,
or
Bachelor's degree with 8+ years of experience in a relevant field (e.g., life sciences, healthcare, or related discipline)
Demonstrated experience independently drafting CSRs, ICFs, IBs, protocols, and/or CTD modules
Strong written and verbal communication skills
Exceptional attention to detail and commitment to quality
Proficiency with Microsoft Office and familiarity with scientific writing tools
Ability to thrive in a fast‑paced, collaborative environment
Knowledge of clinical research, regulatory requirements, and biotechnology is a plus
Compensation & Benefits
The company offers a competitive compensation package that includes base salary, bonus potential, and equity participation, along with a comprehensive benefits program, which may include:
401(k) with company matching
Comprehensive medical, dental, and vision coverage
Mental health and wellness programs
Generous paid time off and company holidays
Seasonal company shutdowns
Life and AD&D insurance
Enhanced parental leave
On‑site or subsidized meal programs (where applicable)
Expected salary range:
$148,000 - $161,500, depending on experience, skills, and market conditions.
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Company Overview
A privately held biopharmaceutical company is leveraging innovative technologies at the intersection of chemistry, engineering, computation, and biology to advance the discovery of novel therapies for serious and life‑threatening diseases. The organization operates in a highly collaborative, fast‑paced environment and is focused on translating cutting‑edge science into meaningful clinical impact.
Position Summary
The Senior Medical Writer II plays a key role in translating complex scientific and medical information into clear, accurate, and high‑quality written materials. This individual will contribute to a broad range of documents supporting research, clinical development, and regulatory activities, working closely with cross‑functional teams across the organization.
About the Ideal Candidate
The ideal candidate is a strong scientific communicator with exceptional attention to detail and the ability to clearly convey complex concepts to diverse audiences. This role requires comfort working independently, managing multiple priorities, and collaborating in a dynamic environment. Experience with clinical research and regulatory documentation is highly valued.
Key Responsibilities
Document Development:
Author and support the preparation of a variety of medical and scientific documents, including clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), informed consent forms (ICFs), regulatory submissions, and scientific publications.
Cross‑Functional Collaboration:
Partner with clinical, regulatory, and scientific teams to gather, interpret, and accurately present data.
Regulatory Compliance:
Ensure all documents comply with applicable regulatory guidelines, industry standards, and internal quality requirements.
Literature Review:
Conduct comprehensive literature searches and synthesize findings to support evidence‑based content development.
Data Interpretation:
Summarize complex scientific and clinical data clearly for both technical and non‑technical audiences.
Editing & Quality Control:
Review and edit documents for clarity, consistency, grammar, and scientific accuracy.
Mentorship:
Provide guidance and support to junior medical writers, contributing to their professional development.
Qualifications
PhD with 3+ years of relevant experience,
or
Master's degree with 6+ years of experience,
or
Bachelor's degree with 8+ years of experience in a relevant field (e.g., life sciences, healthcare, or related discipline)
Demonstrated experience independently drafting CSRs, ICFs, IBs, protocols, and/or CTD modules
Strong written and verbal communication skills
Exceptional attention to detail and commitment to quality
Proficiency with Microsoft Office and familiarity with scientific writing tools
Ability to thrive in a fast‑paced, collaborative environment
Knowledge of clinical research, regulatory requirements, and biotechnology is a plus
Compensation & Benefits
The company offers a competitive compensation package that includes base salary, bonus potential, and equity participation, along with a comprehensive benefits program, which may include:
401(k) with company matching
Comprehensive medical, dental, and vision coverage
Mental health and wellness programs
Generous paid time off and company holidays
Seasonal company shutdowns
Life and AD&D insurance
Enhanced parental leave
On‑site or subsidized meal programs (where applicable)
Expected salary range:
$148,000 - $161,500, depending on experience, skills, and market conditions.
#J-18808-Ljbffr