Senior Medical Writer, Promotional Review

Thermo Fisher Scientific • Waltham, MA

3d • $130,000 - $150,000

About The Position

The Senior Medical Writer - Promotional Review, provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients and demonstrates subject matter and therapeutic area expertise and may provide assistance to the program manager. Additionally, as part of the Medical Affairs Consulting Team - the Senior Medical Writer may assist in medical affairs consulting services and the review of promotional medical materials against FDA-OPDP requirements. The role involves collaborating with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.

Requirements

• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
• Equivalent of 3-years working experience in the independent review of promotional medical collateral as part of a Medical/Legal/Regulatory (MLR) Team or Promotional Review Committee
• 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

• Experience working in the pharmaceutical/CRO industry preferred
• Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
• Strong background in Veeva PromoMats and related PRC CRM-based platforms.

Responsibilities

• Medical Information Serve as primary author who writes and provides input on routine medical information documents such as Standard Response Letters, Frequently Asked Questions (FAQs), and summarize data from clinical studies.
• Review 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.
• Ensure compliance with quality processes and requirements for assigned documents.
• Provide input on and independently develops best practices, methods and techniques for achieving optimal results, including various client specific processes.
• May assist in program management activities.
• Identify and resolve out-of-scope activities.
• Duties could include developing timelines, budgets, forecasts and contract modifications.
• Represent the department at project launch meetings, review meetings, and project team meetings.
• 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 applicable regulations and codes of practice (e.g., FDA, Health Canada, ABPI, EFPIA, IFPMA-AIFD) and assures appropriate level of language for intended audience (i.e., HCP, patient/consumer, other).
• Upon review and where consultative review comments are necessary, annotations are provided along with rationale and suggested language.
• Provide support for Medical Affairs and Field Force based materials, strategy planning, NCCN Submissions and other medical affairs-based activities.

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: Mid Level