Senior Medical Writer, Promotional Review

Thermo Fisher Scientific • Waltham, MA

11d • $130,000 - $150,000 • Onsite

About The Position

The Senior Medical Writer, Promotional Review, provides high-quality medical review for promotional and non-promotional collateral against local standards, best practices and FDA-OPDP requirements. Additionally, as part of the MHWC Writing Team, may support medical information writing activities such as drafting and/or reviewing Standard Response Letters, FAQs, and product Dossiers. The role involves collaborating with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.

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.
• Great judgment and decision-making skills
• Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)

Nice To Haves

• In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Responsibilities

• 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.
• Reviews FDA communications, recent action letters, provides risk-mitigation strategy.
• Provides support for general medical affairs and field force-based materials, strategy planning, NCCN Submissions and other medical affairs-based activities.
• Serves as primary author who writes and provides input on routine medical information documents such as Standard Response Letters, Frequently Asked Questions (FAQs), and summarizes data from clinical studies.
• Reviews routine documents prepared by junior team members.
• May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.
• Ensures compliance with quality processes and requirements for assigned documents.
• Provides input on and independently develops best practices, methods and techniques for achieving optimal results, including various client specific processes.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior