Associate Director Medical Writing

The Associate Director, Medical Writing will be responsible for representing Medical Writing and provide leadership in one or more therapeutic areas, overseeing more junior writers working on documents in their therapeutic area, and leading the Medical Writing effort in a clinical filing. The Associate Director will be responsible for working with more senior members of the Medical Writing staff to help produce department guidelines, templates, standard timelines and SOPs that comply with regulatory guidelines. They will be responsible for ensuring adherence to said guidelines templates, timelines and SOPs for all Medical Writing documents provided for their therapeutic area, and they will be responsible for the management and development of staff, including performance management, and training. The individual in this position will work independently writing CSRs, CSPs, CSP amendments, and Clinical Summaries in a variety of therapeutic areas, as well as manage a group of more junior writers.

A typical day might include the following:

Working with the clinical team, be responsible for writing following documents:

• Clinical Study Protocols
• Clinical Study Protocol Amendments
• Clinical Study Reports
• Investigator brochures
• Clinical Summaries
• Other documents, as needed

This role might be for you:

• Leads all Medical Writing deliverable work for a therapeutic area, compound or indication.
• Represents Medical Writing at cross-company and TA meetings.
• Drive meetings;
• Participants look to this person for actions and decisions
• Articulate document strategy and timelines;
• Be able to identify the best parties for a document content decision, and if a discussion is faltering, bring the discussion back on track with minimal fuss.
• Follows a discussion to its conclusion, synthesize the message, and present clear accurate prose quickly.
• Leads Regulatory Submission document writing
• Manages processes and organize priorities; Tackle problems; Foster teamwork to resolve conflict
• Take ownership for leading, challenging, and developing Medical Writing team
• Collaborates with Management to set the requirements for department guidelines, templates, timelines and SOPs to ensure compliance with applicable regulatory guidance and industry standards.
• Responsible for the management and development of staff including: performance mgmt., recruiting, mentor and training.

To be considered for this opportunity, you must have a Bachelor’s Degree and 8+ years of medical writing experience. We expect to see previous managerial experience as well from applicants. Submission Management including having knowledge of eCTD, submission systems, eDMS systems and MS Suite products.

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Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$162,600.00 - $265,400.00