Senior Medical Writer (Promotional Medical Review)- Remote

About the position

In the Senior Medical Writer role focused on Promotional Review work at Thermo Fisher Scientific, you will provide tailored high-level support in the area of promotional medical review. This includes reviewing promotional and non-promotional materials for clinical and scientific accuracy, fact-checking against source documentation, and ensuring the context and tone of language comply with relevant national and regional regulations and codes of practice. You will also be responsible for delivering high-quality medical and scientific writing, from planning and coordinating literature searches to delivering final drafts to internal and external clients. Your role will involve providing technical consultation and substantive advice on strategy, regulations, and industry best practices, demonstrating subject matter and therapeutic area expertise. You will effectively manage medical writing projects to deliver quality products within agreed timelines, collaborating with internal and external clients to support and enable effective communication that results in operational excellence. As a Senior Medical Writer, you will independently manage workflows and review promotional and non-promotional materials for clinical and scientific accuracy against source documentation. You will also review the context and tone of language for compliance with applicable regulations and codes of practice, ensuring the appropriate level of language for the intended audience, whether it be healthcare professionals, patients, or consumers. Your responsibilities will include researching, writing, and editing standard medical information writing deliverables across various therapeutic areas, as well as managing all aspects of planning, organizing, and executing projects without supervision. This includes developing project timelines, standards, budgets, forecasts, and contract modifications, while liaising with other functional units as necessary. You will represent the department as a primary contact on projects, establishing and developing client relationships, and assisting with business development and the development of budgets and proposals. Your role will require you to demonstrate good judgment in selecting methods and techniques for obtaining solutions, and you will be expected to work on problems of diverse scope where analysis of data requires evaluation of identifiable factors. This position is integral to ensuring that the materials produced meet the highest standards of quality and compliance, ultimately supporting the mission of making the world healthier, cleaner, and safer.

Responsibilities
? Independently manage workflows and review promotional and non-promotional materials for clinical and scientific accuracy against source documentation.
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? Review context and tone of language for compliance with applicable regulations and codes of practice.
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? Research, write, and edit standard medical information writing deliverables across various therapeutic areas.
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? Manage all aspects of planning, organizing, and executing projects without supervision, including developing project timelines, standards, budgets, forecasts, and contract modifications.
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? Liaise with other functional units as necessary, such as legal, finance, project management, clinical, QA, data management, biostatistics, and regulatory.
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? Represent the department as a primary contact on projects, including Project Launch Meetings, Review meetings, client audits, bid defenses, and capabilities presentations.
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? Establish and develop client relationships; independently initiate and lead interactions with clients.
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? Assist with business development and development of budgets and proposals.

Requirements
? Bachelor's degree in a scientific discipline or equivalent and relevant formal academic/vocational qualification; PharmD is highly preferred.
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? Prior Promotional Review experience required.
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? Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years') or equivalent combination of education, training, & experience.
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? Experience working in the pharmaceutical/CRO industry preferred.
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? Additional qualifications in medical writing (e.g., AMWA; EMWA; RAC) advantageous.
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? Significant knowledge of relevant global, national, and regional guidelines including regulations and codes applicable to the dissemination of promotional, non-promotional, and reactive medical information to stakeholders of interest.
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? In-depth knowledge in a specialty area such as medical affairs, medical information, preclinical, therapeutic, regulatory submissions, communications, etc.
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? Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Word, Excel, Outlook).

Nice-to-haves
? Experience in medical writing for various therapeutic areas.
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? Familiarity with FDA, Health Canada, ABPI, EFPIA, IFPMA-AIFD regulations and codes of practice.

Benefits
? A choice of national medical and dental plans, and a national vision plan, including health incentive programs.
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? Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
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? 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).
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? Accident and life insurance, and short- and long-term disability in accordance with company policy.
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? Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan.
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? Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount.

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