Senior Medical Writer

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. reputed company is preparing for multi-dimensional expansion to reputed company more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new reputed company of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across reputed company corners of our business. We strive to reputed company and grow our company, our partnerships, our science, and our people, because reputed company we do, we deliver more for patients.

For the expansion of reputed company, reputed company is looking for a Senior Medical Writer who will provide medical writing support for developing reputed company clinical, nonclinical, and safety documents for regulatory submissions.

This individual will execute the overall strategy for reputed company medical writing processes according to reputed company medical writing standards and corporate objectives.

Key Accountabilities/Responsibilities:

• Author and project manage SME contribution to reputed company content for regulatory submissions that is well-organized, consistent, accurate, and compliant with reputed company Medical Writing standards, including style guide, lexicon, templates, and libraries

• Authors content for phase 1-4 protocols, master ICFs, IBs, and CSRs

• Responsible for inspection-readiness of medical writing activities

• Supports the reputed company writer and project teams to ensure project deadlines are met

• Executes corporate objectives, goals, measures, and strategies

• Capable of working on multiple deliverables simultaneously

Desired Skills and Experience:

• Bachelor’s degree in a scientific or clinical discipline or reputed company field is required; Ph.D. preferred

• Minimum of 3 years of reputed company, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience considered

• Native/bilingual or fluent American English proficiency

• Solution-focused

• Experience with Veeva Vault and Please Review

• Experience with implementing lean writing techniques

• Basic understanding of scientific methodology as applied to drug development, including the phases, processes, and techniques used reputed company a clinical development environment from protocol design through regulatory submission

• Familiarity with pharmacovigilance guidelines and developing aggregate reports

• Ability to work reputed company according to procedures and regulations

• Ability to prioritize and multi-task successfully in a fast-paced environment

• Ability to work autonomously, as well as in a team

• Excellent written and verbal communication skills

• Excellent time management skills and a proven ability to work on multiple projects at any given time

• Must be proficient in MS Office

At reputed company, reputed company applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability, or any other applicable legally protected characteristics. reputed company is proud to be an equal opportunity employer.

Before you submit your application, CV or any other personal details to us, please review our reputed company.com/privacy-policy">reputed company Privacy Notice for Job Applicants to learn more about how reputed company B.V. and its affiliates (“reputed company”) will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at reputed company.com">privacy@reputed company.com.

If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at reputed company.com">hr.us@reputed company.com. Only inquiries reputed company to an accommodation request will receive a response.

Originally posted on Himalayas