Senior Medical Writer, Promotional Review

Work Schedule

Environmental Conditions

Job Description

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.

What Youll Do:

Promotional Review and Medical Affairs Consulting

• 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.

Medical Information

• 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.

Education & Experience 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.

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.

Knowledge Skills Abilities:

• 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)

Work Environment:

Thermo Fisher values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate receive and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel. (Recruiter will provide more details.)

Why Join Us

When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• 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

For more information on our benefits please visit: Experience:

Senior IC