Senior or Principal Regulatory Medical Writer

Senior or Principal Regulatory Medical Writer Would you like to join one of the fastest-growing organizations with a stated goal of using latest and greatest AI, GenAI, LLM, Cloud and Digital Technologies to advance drug development and improve patient care pathways. WriteMed.AI helps Biopharma and Life Sciences Companies, among others, to reduce the time for writing medical publications and regulatory documents. Our Medical Writing Team support our customers’ missions with creative and transformative spirit of innovation across all therapeutic areas. Role Overview This is an opportunity to be a Principal or Senior Medical Writer, to guide our AI Architects, Data Scientists and Engineers towards medical writer needs, evaluate and improve the quality of outputs, and be the voice of the customers internally.

Required Qualifications

• This position will be a remote position, with occasional ( approximately 10-20%) travel to client

sites and conferences

• Doctoral Degree (MD, PhD, PharmD or equivalent) in life sciences or related discipline, and 10+

years of work experience in academia or industry with at least 5+ years of medical writing work experience in the industry

• Or, M.S. Degree and 15+ years of experience with at least 7+ years of medical writing work

experience in the industry

• Extensive experience writing 4 or more of the following: IND components, Clinical Study

Reports, Protocols, Investigator Brochures, Informed Consent Forms, 510Ks, NDAs

• Strong ability to accurately interpret or check interpretation of statistical findings
• 5+ years of experience fact-checking references, statistical interpretation, and consistency
• Experience writing in accordance with AMA manual of style
• 10+ years of experience using PubMed and Endnote (or Endnote equivalent)
• Complete/Native fluency in English language
• Thorough understanding of US Healthcare landscape

Preferred Qualifications

• Professional oral and written communication skills, presenting to an audience containing one or

more executive team members

• Familiarity with Information Technology or AI applications in regulatory medical writing
• Experience applying technical or scientific expertise to identify, balance trade-offs, and solve

difficult challenges

Responsibilities

• Fact-check AI generated documents for accuracy with respect to reference and data

interpretation and summary, as well as adherence to AMA manual of style. Provide statistical summary of document quality

• Assist in training our AI Systems and enriching our database
• Be the voice of the customers for AI Product Development teams
• Interface with Information Technology / AI team to align product development with latest needs

of medical writers across the globe

• Suggest improvements to AI generated medical documents, so as to achieve outstanding

document quality, accuracy, and style

• Be the regulatory writing SME
• Our benefits help you thrive personally and professionally, from wellness programs and tuition

reimbursement to expense reimbursement programs that can be used for needs that best suit you and your family, from student loan repayment, to childcare, to pet insurance

• Our inclusive culture, active and engaged employee resource groups, and caring leaders value

every voice and support you in doing the best work of your career

• The pay range for this position is $160,000 to $190,000, however, base pay offered may vary

depending on skills, experience, job-related knowledge and location

• This position is also eligible for a short-term incentive and a long-term incentive as part of total

compensation #J-18808-Ljbffr Remote About the Company: Writemed Apply tot his job Apply To this Job