Manager, Medical Writing FSP

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

📋 Description

• Oversees the work of Medical Writers, ensuring effective resource planning to allocate projects to the suitable and available personnel.

• Manages the creation of Medical Writing deliverables.

• Conducts marketing presentations for prospective clients to showcase the capabilities of the Medical Writing team.

• Designs and maintains training initiatives for Medical Writing staff.

• Utilizes clinical expertise to aid in the written analysis of clinical data and to guide colleagues in presenting this information.

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

⛳️ Requirements

• A Bachelor’s degree in a science-related discipline is mandatory; an advanced degree (PharmD, PhD, Masters) is preferred.

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

• A minimum of 2 years of pertinent experience in medical writing, ideally within the pharmaceutical sector.

• At least 1 year of leadership experience.

• Proficient in supervising, evaluating, and mentoring team members.

• Capable of managing assignments, monitoring team workload, and providing direction for task completion.

• Skilled in creating and adjusting project timelines, allocating resources, and predicting departmental workload.

• Comprehensive understanding of departmental procedures and the ability to contribute to their enhancement and development.

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

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

• Competence in developing, reviewing, and revising proposals and budgets for client presentations.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Paid time off

• Flexible work hours

• Professional development opportunities