Senior Medical Writer – Regulatory

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

📋 Description

• Oversee the precise and timely completion of medical writing deliverables while coordinating activities both within and across various departments.

• Prepare clinical and regulatory documents, which encompass protocols, clinical study reports, patient narratives, investigator brochures, informed consent forms, safety reports, development plans, IND submissions, integrated summaries, NDA/eCTD submissions, manuscripts, abstracts, posters, and presentations.

• Ensure compliance with ICH E3 guidelines, as well as company and client standards, templates, authorship requirements, and style guides, all while delivering projects on schedule and within budget.

• Facilitate quality and editorial reviews, manage source documentation, lead document reviews within the team, and conduct peer reviews.

• Assess statistical analysis plans and table/figure/listing specifications for accuracy, grammar, formatting, and consistency.

• Establish and nurture working relationships with clients, and collaborate with data management, biostatistics, regulatory affairs, and medical affairs teams.

• Conduct online clinical literature searches while adhering to copyright requirements.

• Identify and address issues, offer technical support, training, and consultation, and contribute to the enhancement of internal materials and processes.

• Mentor and guide less experienced medical writers on complex projects.

• Cultivate expertise in industry topics and regulatory requirements impacting medical writing.

• Monitor project budgets, communicate updates and changes to medical writing leadership, and fulfill administrative responsibilities.

• Undertake additional assigned duties; minimal travel may be necessary, amounting to less than 25%.

⛳️ Requirements

• Proven experience and proficiency in medical writing along with a strong understanding of regulatory requirements relevant to the role's responsibilities.

• Capability to generate clear and precise scientific information, and deliver medical writing outputs with minimal oversight.

• Familiarity with ICH E3 guidelines and relevant regulatory standards.

• Competence in adhering to company/client SOPs, approved templates, authorship requirements, and style and formatting guidelines.

• Ability to coordinate quality, editorial, team, and peer reviews effectively.

• Skill in reviewing statistical analysis plans and table/figure/listing specifications.

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

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

• Ability to mentor junior medical writers on intricate projects.

• Aptitude for working within budgeted hours and effectively communicating project status and changes.

• Minimal travel may be necessary, amounting to less than 25%.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• Company car or car allowance.

• Medical, dental, and vision health benefits.

• Company matching 401(k) plan.

• Eligibility to partake in the Employee Stock Purchase Plan.

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

• Flexible paid time off (PTO).

• Sick leave provisions.

• Reasonable accommodations available when appropriate.