Medical Writer (Part-Time) 2074331

Stratacuity: Proven Scientific Placement; United States; Remote; USD 90,000 - 130,000; Part time

Job summary

A leading company in the biotechnology and pharmaceutical industry is seeking a Medical Writer to produce high-quality regulatory documents. This remote position requires expertise in oncology clinical trials and a strong background in regulatory submissions. The role involves collaboration with various teams and mentoring junior writers, making it ideal for experienced professionals looking to impact clinical development programs significantly.

Qualifications

• 5+ years of medical writing experience, including 3+ years in oncology trials.
• Proven skills in authoring Phase I–III trial documents and regulatory submissions.

Responsibilities

• Develop and edit oncology trial documents, including study protocols and consent forms.
• Collaborate with teams for document accuracy and compliance with guidelines.

Skills

Communication

Attention to Detail

Project Management

Education

PhD

MSc

Tools

MS Office

Document Management Systems

Job description

Direct message the job poster from Stratacuity: Proven Scientific Placement

Account Executive at Stratacuity: Proven Scientific Placement

Location: Remote

Job Overview: In this role, you will be an expert Medical Writer responsible for crafting top-notch regulatory and scientific documents, utilizing your extensive background in oncology clinical trials and deep knowledge of oncology therapeutics to support our clients clinical development programs.

Primary Job Responsibilities:

• Develop and edit key oncology trial documents, including study protocols, CSRs, and consent forms.
• Prepare regulatory submissions content for INDs, NDAs, and BLAs, pivotal for approvals.
• Collaborate with teams across Clinical Development and Regulatory Affairs for document accuracy.
• Translate complex data into clear, scientifically sound documents.
• Ensure document compliance with ICH guidelines and company SOPs.
• Mentor junior medical writers and stay updated on industry trends and guidelines.

Primary Job Requirements:

• Advanced degree (PhD, PharmD, MD, MSc) in life sciences or related field, with 5+ years of medical writing experience, including 3+ years in oncology trials.
• Expertise in NSCLC and breast cancer, especially small molecule kinase inhibitors.
• Proven skills in authoring Phase I–III trial documents and regulatory submissions.
• Strong knowledge of oncology, clinical endpoints, ICH-GCP, FDA/EMA guidelines, and trial processes.
• Exceptional communication, attention to detail, and ability to manage multiple projects efficiently.
• Proficient in document management systems, MS Office, templates, and style guides.
• Familiarity with eCTD submission processes and regulatory publishing.
• Experience in biotech, pharma, or CRO environments; professional organization membership (e.g., AMWA, EMWA) is a plus.

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Part-time

Job function

• Job function

  Science and Writing/Editing

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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