Location: Cambridge, MA (Hybrid)

Science: Small Molecule

Therapeutic Area : Oncology

Job Overview : Lead the development and timely delivery of clinical and regulatory documentation, ensuring quality, consistency, and regulatory alignment, while coordinating with cross-functional teams and managing communication across the document lifecycle.

Primary Job Responsibilities:

• Manage medical writing (MW) projects, ensuring the accurate and timely delivery of clinical and regulatory documents to health authorities through effective timeline management and communication.
• Drive cross-functional collaboration with key internal stakeholders, including department heads and SMEs from Clinical Research to Clinical Pharmacology, to create scientifically robust, regulation-compliant clinical documents.
• Lead the interpretation and presentation of clinical data, aligning document development with regulatory standards and strategic objectives through close coordination with authors and program teams.
• Oversee the document development process, including organizing roundtables, facilitating document reviews and approvals, ensuring quality control, and addressing content-related issues and technical challenges.

Primary Job Requirements:

• Over 3 years in regulatory document management, with medical writing experience in pharma/biotech/healthcare a plus.
• Proficient in statistics and scientific content, capable of preparing submission-ready documents.
• Knowledgeable in CTD structure, electronic document systems, and IT, with excellent Windows software skills.

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.