Jobgether
PRINCIPAL MEDICAL WRITER
TLDR
Lead development of regulatory and scientific documents for global drug programs, guiding cross-functional teams and driving process improvements in medical writing.
Accountabilities:
- Independently author, review, and finalize high-quality regulatory documents, including Clinical Study Reports (CSRs), Protocols, Investigator’s Brochures (IBs), Briefing Books, CTD modules, and other submission-related materials for global regulatory agencies.
- Develop scientific and medical communication deliverables such as manuscripts, abstracts, posters, slide decks, and other technical or scientific publications as required.
- Collaborate with statisticians, data analysts, and clinical teams to support real-world evidence generation and other scientific research initiatives.
- Ensure all deliverables meet scientific, regulatory, editorial, and quality standards while adhering to applicable ICH guidelines and industry best practices.
- Perform scientific reviews, quality control assessments, proofreading, and document validation activities to maintain high-quality outputs.
- Lead client interactions, project kick-off meetings, and cross-functional discussions while managing communication across global time zones.
- Serve as a project lead for assigned accounts, ensuring successful delivery, strong client relationships, and overall project satisfaction.
- Drive innovation initiatives, process optimization efforts, and automation opportunities to enhance efficiency and quality within the medical writing function.
- Design and deliver training programs that strengthen technical expertise and support the professional development of team members.
- Support audit readiness activities, contribute to SOP and work-instruction development, and ensure compliance with internal quality systems.
- Participate in business growth initiatives, operational improvements, and strategic departmental activities as needed.
- Provide leadership, coaching, performance management, mentoring, and career development support for medical writing team members.
- PharmD, M.Pharm, PhD, MD, or postgraduate degree in Life Sciences, Medical Sciences, Pharmacy, or a related healthcare discipline.
- 10–11+ years of experience in medical writing, clinical research, or drug development environments.
- Minimum 5 years of hands-on experience authoring regulatory medical writing deliverables for global submissions.
- Strong understanding of clinical development processes, regulatory requirements, and submission standards across major health authorities.
- Experience preparing regulatory documents for agencies such as the FDA, EMA, and other international regulatory bodies.
- Scientific publication writing experience, including manuscripts, abstracts, and posters, is desirable.
- Advanced proficiency in Microsoft Office Suite, particularly Microsoft Word and document management functionalities.
- Excellent written, verbal, presentation, and scientific communication skills.
- Strong organizational, analytical, and problem-solving abilities with exceptional attention to detail.
- Demonstrated ability to manage multiple projects simultaneously while meeting strict deadlines.
- Proven leadership experience with the ability to mentor, train, and develop high-performing teams.
- Strong interpersonal skills and the ability to collaborate effectively with diverse stakeholders at all organizational levels.
- Adaptability, flexibility, and the ability to perform effectively in evolving and fast-paced environments.
- Sound judgment, decision-making capabilities, and a commitment to excellence and continuous improvement.
- Opportunity to work on global clinical development and regulatory submission programs.
- Exposure to diverse therapeutic areas and international regulatory environments.
- Leadership responsibilities with opportunities to mentor and develop medical writing professionals.
- Collaborative, science-driven, and client-focused work environment.
- Involvement in strategic initiatives, innovation programs, and process improvement projects.
- Professional growth opportunities within a globally focused clinical research organization.
- Flexible and dynamic work environment supporting cross-functional collaboration.
- Participation in high-impact scientific communication and evidence-generation initiatives.
- Career advancement opportunities within a growing and specialized medical writing function.
Requirements:
Benefits:
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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Benefits
Career advancement in medical writing
Career advancement opportunities within a growing and specialized medical writing function.
Jobgether runs the largest remote job platform, effectively linking job seekers with over 200,000 flexible and remote opportunities that match their unique skills and preferences. Our focus is on enhancing the hiring process, ensuring efficiency while prioritizing the candidate experience, particularly in the growing health and wellness sector.
- Founded
- Founded 2020
- Employees
- 11-50 employees
- Industry
- Professional Services