Provides tailored high-level support in the area of promotional medical review, including review of promotional and non-promotional materials for clinical and scientific accuracy, fact-checking against source documentation, and for context and tone of language against relevant national and regional regulations and codes of practice. In addition, the Senior Medical Writer will provide high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external clients. Provides technical consultation and provides substantive advice on strategy, regulations, and industry best practices. Demonstrates subject matter and therapeutic area expertise. Effectively manages medical writing projects to deliver quality products in agreed timelines. Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.

Essential Functions:

Independently manages workflows and 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.

Independently researches, writes, and edits standard medical information writing deliverables across various therapeutic areas. Independently writers more complex medical writing deliverables. Examples may include global or regional standard response documents, custom responses, and FAQs. Provides senior review of documents and training/mentoring for other writers.

Manages all aspects of planning, organizing, and executing projects without supervision including: developing project timelines, standards, budgets, forecasts, and contract modifications. Liaises with other functional units as necessary (e.g, legal, finance, project management, clinical, QA, data management, biostatistics, regulatory). Identifies and escalates out-of-scope project activities in a timely manner and proposes solutions.

May manage several long-term projects concurrently.

Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.

Interacts with internal and external personnel on significant matters often requiring coordination between functional areas. Networks with senior internal and external personnel in own area of expertise.

Normally receives little instruction on day-to-day work, and general instructions on new assignments. Demonstrates good judgment in selecting methods and techniques for obtaining solutions.

Consulting Expectations:

Represents the department as a primary contact on projects including Project Launch Meetings, Review meetings, client audits, bid defenses, and capabilities presentations. Establishes and develops client relationships; independently initiates and leads interactions with clients. Assists with business development and development of budgets and proposals.

Education, Professional Skills & Experience requirements:

Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; PharmD is highly preferred for this particular role due to the nature of the work.

Prior Promotional Review experience required

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years') or equivalent combination of education, training, & experience.

Experience working in the pharmaceutical/CRO industry preferred.

Additional qualifications in medical writing (e.g., AMWA; EMWA; RAC) advantageous.

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.

In-depth knowledge in a specialty area such as medical affairs, medical information, preclinical, therapeutic, regulatory submissions, communications, etc.

Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Word, Excel, Outlook).

Personal Skills & Competencies:

Aptitude to accurately work with, manipulate and format numbers, numerical information, and data of various types to provide evidence, information, and insights.

Demonstrated ability to communicate and document information effectively in written English, including the ability to produce reports, documents, emails and other written pieces which are well-organized, free from errors, and are appropriately adjusted to the characteristics and needs of the audience.

Able to analyze complex issues and evidence, identify cause-effect relationships, and generate effective solutions.

Able to create, communicate, and manage effective project plans that support the delivery of overall project objective(s); to identify, manage and guide project team members; to monitor and report on progress in an organized fashion; and to deliver the required results.

Demonstrates sound professional judgment in analyzing, responding to, and resolving inquiries, issues and escalations.

Able to facilitate the resolution of conflict among team members and clients, through listening and understanding the cause(s), gaining agreement on an appropriate course of action, and following up to ensure a successful outcome.

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Compensation and Benefits
The salary range estimated for this position based in North Carolina is -.

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: https://jobs.thermofisher.com/global/en/total-rewards