Manager, Medical Writing FSP

Accountabilities:
As a Manager, Medical Writing FSP, you will lead medical writing operations, manage team performance, and ensure the timely delivery of accurate and compliant clinical documentation. You will oversee resource planning, quality standards, regulatory alignment, and continuous improvement initiatives while supporting the growth and development of medical writing professionals. Lead, mentor, and develop Medical Writers while managing workload distribution, performance, and career development. Plan short-term and long-term resources to assign projects effectively based on skills, availability, and business needs. Oversee the preparation, review, and delivery of medical writing documents within established timelines and quality standards. Provide guidance on clinical study design, adverse event reporting, statistical analysis, and interpretation of clinical data. Perform senior-level reviews to ensure documents meet departmental standards and regulatory expectations. Develop, review, and maintain standard operating procedures (SOPs), work practice documents (WPDs), and operational guidelines. Monitor compliance with internal processes and applicable regulatory requirements, including ICH and FDA guidelines. Support business development activities through client presentations, proposals, budgets, and capabilities discussions. Collaborate with bids, contracts, and commercial teams to support medical writing project planning. Design and maintain training programs to ensure team members have the necessary skills and knowledge. Prepare and coordinate regulatory submission documents, including IND, NDA, and CTD-related materials. Identify opportunities to improve medical writing processes, workflows, and operational efficiency. Requirements: The ideal candidate is an experienced medical writing professional with strong leadership capabilities and a deep understanding of clinical research documentation. You should have proven experience managing teams, interpreting complex clinical data, and delivering high-quality regulatory documents within a pharmaceutical or life sciences environment. Bachelor’s degree in a science-related field required; advanced degree such as PharmD, PhD, or Master’s degree is preferred. 5+ years of relevant experience in medical writing, clinical research, or a related life sciences discipline. At least 2 years of experience in medical writing, preferably within the pharmaceutical or biotechnology industry. Minimum 1 year of leadership or people management experience. Strong ability to supervise, mentor, and evaluate medical writing professionals. Experience managing project timelines, resource allocation, and workload forecasting. Excellent medical writing, editing, proofreading, and scientific communication skills. Ability to interpret, summarize, and present complex clinical and scientific data effectively. Strong knowledge of clinical development processes, regulatory documentation, and submission requirements. Familiarity with ICH, FDA, and other relevant regulatory guidelines. Strong communication, negotiation, and presentation skills for client-facing interactions. Experience developing proposals, budgets, and project documentation is highly valued. Ability to work independently, manage multiple priorities, and collaborate with global stakeholders. Benefits: Fully remote working opportunity from India. Full-time position with a standard Monday-to-Friday schedule. Opportunity to lead a specialized medical writing team supporting global clinical programs. Exposure to innovative healthcare, pharmaceutical, and regulatory projects. Leadership role with opportunities to mentor and develop talented professionals. Collaboration with international teams across clinical research and life sciences functions. Opportunity to contribute to impactful regulatory submissions and healthcare advancements. Professional growth through continuous learning, process improvement initiatives, and complex scientific projects.

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