Associate Director, Regulatory Medical Writing
Regeneron Pharmaceuticals, Inc, Raleigh, North Carolina, United States
As an Associate Director, Medical Writing, you will represent Medical Writing and provide leadership in one or more compound areas, oversee junior writers, and may assist in leading regulatory submissions. We work closely with senior Medical Writing management to help produce and ensure adherence to department guidelines, templates, standard timelines, and SOPs that follow regulatory guidelines. Responsibility will also include managing and developing staff; this may include performance management and training. Additionally, you will independently write all in-scope clinical documentation in their compound areas.
This position can be either fully remote or can be on-site at our Sleepy Hollow, NY or Warren, NJ offices.
A typical day may include the following:
Leads all MW deliverable work for assigned compounds/indications
Manages work of both internal and outsourced Medical Writers
Works with clinical team to develop document strategy and write in-scope deliverables as needed
Develops and articulates document strategy and timelines
Identifies appropriate decision makers, focuses on results/actions.
Leads regulatory submissions/submission document writing
Participates in process improvement initiatives, working groups, etc. within MW and throughout Global Development
Participates in new initiatives within MW and throughout Global Development
Manages processes and organizes priorities; solves problems; fosters collaboration to resolve conflict
Leads, challenges, and develops MW team
Manages and develops staff; this may include performance management, recruiting, coaching, and training
Ensures adherence to applicable guidelines, templates and SOPs for all MW documents provided for therapeutic area
Remains compliant with internal training
This may be for you if you:
Present as a leader; is looked to for actions and decisions
Can demonstrate success in managing multiple projects.
Want to have an impact on patient lives.
Are interested in mentoring or leading people
To be considered a bachelor’s degree is required with an advanced degree being preferred. A minimum of 8 years’ relevant Medical Writing experience (relevant advanced degree may offset some of the experience requirement). Expert knowledge of the clinical research process and regulations/guidelines and regulatory writing is required. Expert clinical document reading, writing, and editing experience. Proficiency in MS WORD, Adobe Acrobat, PowerPoint, and electronic document management systems. Thorough understanding of ICH GCP guidelines. Any experience managing medical writers is helpful.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$176,100.00 - $287,300.00
#J-18808-Ljbffr
This position can be either fully remote or can be on-site at our Sleepy Hollow, NY or Warren, NJ offices.
A typical day may include the following:
Leads all MW deliverable work for assigned compounds/indications
Manages work of both internal and outsourced Medical Writers
Works with clinical team to develop document strategy and write in-scope deliverables as needed
Develops and articulates document strategy and timelines
Identifies appropriate decision makers, focuses on results/actions.
Leads regulatory submissions/submission document writing
Participates in process improvement initiatives, working groups, etc. within MW and throughout Global Development
Participates in new initiatives within MW and throughout Global Development
Manages processes and organizes priorities; solves problems; fosters collaboration to resolve conflict
Leads, challenges, and develops MW team
Manages and develops staff; this may include performance management, recruiting, coaching, and training
Ensures adherence to applicable guidelines, templates and SOPs for all MW documents provided for therapeutic area
Remains compliant with internal training
This may be for you if you:
Present as a leader; is looked to for actions and decisions
Can demonstrate success in managing multiple projects.
Want to have an impact on patient lives.
Are interested in mentoring or leading people
To be considered a bachelor’s degree is required with an advanced degree being preferred. A minimum of 8 years’ relevant Medical Writing experience (relevant advanced degree may offset some of the experience requirement). Expert knowledge of the clinical research process and regulations/guidelines and regulatory writing is required. Expert clinical document reading, writing, and editing experience. Proficiency in MS WORD, Adobe Acrobat, PowerPoint, and electronic document management systems. Thorough understanding of ICH GCP guidelines. Any experience managing medical writers is helpful.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$176,100.00 - $287,300.00
#J-18808-Ljbffr