Medical Writer (Part-Time)

Apex Systems; Cambridge (MA); Remote; USD 70,000 - 100,000; Part time

Job summary

Apex Systems is seeking a part-time Medical Writer specializing in oncology to develop regulatory documents crucial for clinical trials. The ideal candidate will have a strong background in medical writing and oncology therapeutics to facilitate the approval processes of clinical development programs. Join a collaborative team dedicated to professional growth and excellence in a fully remote position.

Benefits

Comprehensive benefits package

Professional development opportunities

Employee Assistance Program (EAP)

Employee stock purchase program

401K with company match

Qualifications

• 5+ years of medical writing experience with 3+ years in oncology trials.
• Expertise in NSCLC and breast cancer.
• Proficiency with eCTD submission processes.

Responsibilities

• Develop and edit oncology trial documents.
• Prepare regulatory submissions content for INDs, NDAs, and BLAs.
• Ensure compliance with ICH guidelines and company SOPs.

Skills

Attention to detail

Communication

Project management

Education

PhD, PharmD, MD, or MSc in life sciences

Tools

MS Office

Document management systems

Job description

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Job#: 2074331

Job Description:

Medical Writer (Part-Time) 2074331

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.

PROVEN SCIENTIFIC PLACEMENT

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.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex 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 our Employee Services Department at [email protected] or 844-463-6178.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.

Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Apex team member can provide.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.

Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Apex team member can provide.

Apex Systems is part of the Commercial Segment of ASGN Incorporated.

NYSE: ASGN

4400 Cox Road

Suite 200

Glen Allen, Virginia 23060

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex 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 our Employee Services Department at [email protected] (Do not submit resumes or solicit consultants to this email address). UnitedHealthcare creates and publishes the Transparency in Coverage Machine-Readable Files on behalf of Apex Systems.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Part-time

Job function

• Job function

  Marketing, Public Relations, and Writing/Editing

• Industries

  IT Services and IT Consulting

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