Manager, Medical Writing

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

📋 Description

• Oversees Medical Writers, ensuring efficient resource planning for project assignments to suitable and available staff. Conducts regular meetings with the team and updates senior management accordingly. Reviews and approves bi-monthly time sheets. Aids staff in forecasting project-related expenses and completion timelines. Responsible for hiring and evaluating employees, as well as recommending salary adjustments and promotions.

• Manages the preparation of Medical Writing deliverables by organizing processes to meet established deadlines. Assesses the timeliness and quality of deliverables, providing updates to senior management. Serves as a resource for inquiries related to study design, adverse event reporting, and statistical analyses. Supports writers in the presentation and interpretation of data. Conducts senior reviews to ensure compliance with departmental standards. Writes and reviews group SOPs and WPDs, continuously evaluating adherence to these guidelines. Remains informed about the standards and requirements set by ICH, FDA, and other relevant organizations.

• Delivers marketing presentations to prospective clients, showcasing the capabilities of the Medical Writing department. Collaborates with Bids and Contracts and Business Development teams to prepare proposals for Medical Writing projects.

• Designs and maintains training programs for Medical Writing, ensuring that all writers receive adequate training.

• Utilizes clinical expertise to assist in the written interpretation of clinical data and guides others in presenting this data effectively.

• Composes and coordinates various documents for submission to regulatory agencies, including IND, NDA, and CTD items.

⛳️ Requirements

• Bachelor’s degree in a science-related field is required; an advanced degree (PharmD, PhD, or Master's) is preferred.

• Previous experience that equips the candidate with the knowledge, skills, and abilities necessary for the role (equivalent to 5+ years) or a relevant combination of education, training, and experience.

• At least 2 years of relevant experience in medical writing, preferably in the pharmaceutical industry.

• A minimum of 1 year in a leadership role.

• Capability to supervise, evaluate, and mentor departmental staff.

• Proficient in overseeing assignments, monitoring team workload, and providing guidance for task completion.

• Skillful in creating and adjusting project timelines, allocating resources, and forecasting departmental workload.

• In-depth knowledge of departmental processes with the ability to enhance and develop these processes.

• Exceptional medical writing skills, including strong grammatical, editorial, and proofreading abilities, along with the capacity to effectively interpret and present highly complex data.

• Strong communication, negotiation, and presentation skills essential for representing the department in various contexts, including bid defenses, capability presentations, and audits.

• Ability to develop, review, and adjust proposals and budgets for client presentations.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible working hours

• Paid time off

• Professional development opportunities