Senior Medical Writer, Promotional Review

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Delivers high-quality medical evaluations for both promotional and non-promotional materials, adhering to local standards, best practices, and FDA-OPDP regulations.

• Assists with medical information writing tasks, including the drafting and/or reviewing of Standard Response Letters, FAQs, and product Dossiers.

• Engages with internal and external stakeholders to facilitate effective and efficient communication, driving operational excellence.

• Assesses promotional and non-promotional content for clinical and scientific accuracy based on source documentation, ensuring the context and tone of language comply with FDA-OPDP requirements and are suitable for the target audience.

• Offers strategic justifications for recommended modifications and language adjustments.

• Contributes to and independently formulates best practices, methodologies, and techniques to achieve optimal outcomes, including various client-specific processes.

⛳️ Requirements

• PharmD Degree or equivalent.

• 2-3 years of relevant experience in reviewing promotional medical materials as part of a Medical/Legal/Regulatory (MLR) Team or Promotional Review Committee.

• Strong proficiency in Veeva PromoMats and related PRC CRM-based platforms.

• Exceptional skills in data interpretation and medical writing, including grammar, editing, and proofreading.

• Strong project management capabilities.

• Excellent interpersonal abilities, including problem-solving skills.

• Solid negotiation skills.

• Proficient oral and written communication abilities, complemented by strong presentation skills.

• Extensive knowledge of global, regional, national, and other pertinent guidelines.

• In-depth understanding of various therapeutic specialty areas.

• Excellent computer proficiency with client templates; good familiarity with document management systems and relevant applications (e.g., Excel, Outlook).

🏝️ Benefits

• A selection of national medical and dental plans, along with a national vision plan, including health incentive programs.

• Employee assistance and family support initiatives, including commuter benefits and tuition reimbursement.

• At least 120 hours of paid time off (PTO), 10 paid holidays each year, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability according to company policies.

• Retirement and savings plans, including our competitive 401(k) U.S. retirement savings plan.

• Employees’ Stock Purchase Plan (ESPP) allows eligible colleagues to purchase company stock at a discounted rate.