Senior Medical Writer, Promotional Review

Job Description:

• Provides high-quality medical review for promotional and non-promotional collateral against local standards, best practices and FDA-OPDP requirements.
• Support medical information writing activities such as drafting and/or reviewing Standard Response Letters, FAQs, and product Dossiers.
• Collaborating with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.
• Reviews promotional and non-promotional materials for clinical and scientific accuracy against source documentation, reviews context and tone of language for compliance with FDA-OPDP requirements and assures appropriate level of language for intended audience.
• Provides strategic rationale for suggested changes and language.
• Provides input on and independently develops best practices, methods and techniques for achieving optimal results, including various client specific processes.

Requirements:

• PharmD Degree, or similar.
• Equivalent of 2-3-years working experience in the review of promotional medical collateral as part of a Medical/Legal/Regulatory (MLR) Team or Promotional Review Committee
• Strong background in Veeva PromoMats and related PRC CRM-based platforms.
• Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
• Strong project management skills
• Excellent interpersonal skills including problem solving
• Strong negotiation skills
• Excellent oral and written communication skills with strong presentation skills
• Significant knowledge of global, regional, national and other relevant guidelines
• In-depth knowledge across therapeutic specialty areas.
• Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)

Benefits:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount