Medical Writer (Part-Time)

Medical Writer (Part-Time) 2074331Location: 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 EmployerApex 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. Apply Job! Apply tot his job Apply To this Job