Overview

The Director, Medical Writing reports to the Vice President, Medical Writing and will support Clinical Science and Regulatory functions.

Essential Functions and Responsibilities

• Manage, write, and edit clinical documents for Iovance programs (eg, study protocols, protocol amendments, and Investigator’s Brochures).
• Write and oversee the review of documents toward regulatory submissions such Clinical Overviews, Clinical Summaries, and Clinical Study Reports.
• Develop and manage timelines in collaboration with the Vice President, Medical Writing.
• Collaborate cross-functionally to drive projects to completion.
• In collaboration with Regulatory Affairs, author clinical responses to Health Authority queries.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.

• Perform miscellaneous duties as assigned.

Required Education, Skills, and Knowledge

• Director level - PhD/master’s degree in a life sciences discipline (advanced degree preferred) or equivalent experience and a minimum of 10 years of biopharmaceutical industry experience.
• Experience drafting clinical protocols, Investigator’s Brochures, clinical study reports, and Module 2 documents. Prior regulatory submission experience is required.
• In-depth understanding of regulatory/ICH guidelines and GCPs.
• Expert abilities in Microsoft Office Suite, Adobe Acrobat, and electronic content management systems (eg, Veeva Vault or Documentum).
• Experience with cross-functional collaboration and with managing priorities and timelines.
• Strong written and verbal communication skills.
• Experience in oncology drug development.
• Experience working independently and leading teams to successful submissions.

Preferred Education, Skills, and Knowledge

• Prior regulatory submission experience preferred, especially work toward IND and BLA/MAA submissions.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.

Work Environment

This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.

By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.

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