Senior Medical Writer (Promotional Medical Review)- Remote

Life Technologies

Full-time - Senior

Remote

10,001+ employees

Miscellaneous Manufacturing

About the position

The Senior Medical Writer role at Thermo Fisher Scientific focuses on providing high-level support in promotional medical review, ensuring clinical and scientific accuracy in promotional and non-promotional materials. This position involves managing medical writing projects, collaborating with internal and external clients, and demonstrating expertise in therapeutic areas. The role requires independent research, writing, and editing of complex medical documents, along with mentoring junior writers and managing project timelines and budgets.

Responsibilities

• Independently manage workflows and review promotional and non-promotional materials for clinical and scientific accuracy.
• Review context and tone of language for compliance with applicable regulations and codes of practice.
• Provide annotations and rationale for consultative review comments.
• Research, write, and edit standard medical information writing deliverables across various therapeutic areas.
• Write complex medical writing deliverables such as global or regional standard response documents and custom responses.
• Provide senior review of documents and training/mentoring for other writers.
• Manage all aspects of planning, organizing, and executing projects without supervision.
• Liaise with other functional units as necessary, including legal, finance, and regulatory.
• Identify and escalate out-of-scope project activities in a timely manner and propose solutions.
• Interact with internal and external personnel on significant matters requiring coordination between functional areas.

Requirements

• Bachelor's degree in a scientific discipline or equivalent; PharmD is highly preferred.
• Prior Promotional Review experience required.
• 5+ years of relevant experience in the pharmaceutical/CRO industry or equivalent combination of education, training, and experience.
• Significant knowledge of global, national, and regional guidelines including regulations and codes applicable to medical information dissemination.
• In-depth knowledge in a specialty area such as medical affairs, medical information, or regulatory submissions.
• Excellent computer skills and proficiency with document management systems and applications.

Nice-to-haves

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

Benefits

• A choice of national medical and dental plans, and a national vision plan.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours paid time off (PTO) and 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.
• Retirement and savings programs, including a competitive 401(k) U.S. retirement savings plan.
• Employees' Stock Purchase Plan (ESPP) allowing purchase of company stock at a discount.