Senior Medical Writer – Regulatory Documents, CSR, Protocols, IB

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the precise and thorough execution of medical writing projects.

• Manage medical writing tasks for specific studies and facilitate coordination across departments with minimal oversight.

• Lead the resolution of feedback from clients.

• Prepare clinical study protocols and amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and presentations.

• Comply with regulatory standards, company SOPs, client requirements, approved templates, authorship expectations, and style guides.

• Coordinate quality assurance and editorial assessments and manage source documentation.

• Facilitate team document reviews and serve as a peer reviewer.

• Evaluate statistical analysis plans and specifications for tables, figures, and listings.

• Establish collaborative relationships with clients and cross-functional teams in data management, biostatistics, regulatory affairs, and medical affairs.

• Conduct online searches of clinical literature.

• Identify and propose solutions to problems, escalating issues as necessary.

• Offer technical support, training, and consultation.

• Contribute to the development of internal materials, presentations, processes, standard practices, and capabilities.

• Mentor and guide junior medical writers.

• Cultivate expertise in industry topics and regulatory requirements.

• Monitor project budgets and communicate status updates and changes to medical writing leadership.

• Complete administrative responsibilities and other assigned tasks.

⛳️ Requirements

• Proven experience and extensive knowledge in medical writing and drug development.

• Capacity to produce regulatory medical writing deliverables with clarity and precision.

• Familiarity with ICH E3 guidelines and relevant regulatory standards.

• Ability to adhere to company SOPs, client standards, approved templates, authorship requirements, and style and formatting guidelines.

• Skill in coordinating quality assurance and editorial reviews.

• Proficiency in reviewing statistical analysis plans and specifications for tables, figures, and listings.

• Competence in conducting online clinical literature searches while complying with copyright regulations.

• Capability to provide technical support, training, and consultation.

• Ability to mentor and guide less experienced medical writers on complex projects.

• In-depth understanding of industry topics and regulatory requirements that impact medical writing.

• Capacity to work within allocated hours and communicate status updates and changes effectively.

• Occasional travel may be necessary (less than 25%).

• Equivalent experience, skills, and/or education will also be taken into account.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• Company vehicle or car allowance.

• Medical, dental, and vision health benefits.

• Company-matched 401k.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Opportunity to earn commissions/bonuses based on company and individual performance.

• Flexible paid time off (PTO) and sick leave.

• Reasonable accommodations provided when appropriate.