Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The Senior Medical Writer (SMW) is a key member of the Medical Writing team. The SMW is responsible for development and management of medical writing deliverables that support the clinical regulatory writing portfolio and works with some guidance and oversight to achieve goals. The SMW will support the Oncology therapeutic area including Early or Late Phase development.
In this role the Senior Medical Writer:
*This is a remote based position. The ideal candidate will be based in NC, SC, TN or GA. Qualifications:
- Is recognized as a scientific contributor and subject matter expert in preparation of selected regulatory clinical documentation.
- Applies developing knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects. Participates as part of the medical writing team in cross-functional teams (either internally or externally).
- Demonstrates competence in writing, editing and reviewing of clinical study reports, investigator brochures, registration dossier modules, and other clinical regulatory documents in line with expectations. Able to interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation.
- Manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and sections of filings. Works collaboratively with colleagues across functions to achieve results.
- Solves problems associated with medical writing scope of work, seeking advice from management and others as needed, and exercising negotiation and communication skills with project team members .
- May participate in orientation and coaching of junior team members or contractor writers.
- May participate in initiatives to improve medical writing processes and standards.
- Bachelor's Degree in the Life Sciences with a minimum of 6 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry OR
- MS Degree in the Life Sciences with a minimum of 3 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry OR
- PhD in the Life Sciences with a minimum of 1.5 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry.
- Ability to prepare, with minimal supervision a subset of clinical regulatory documents (e.g., CSR, IB, clinical sections of IND/IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines.
- Participate actively in medical writing and cross-functional project teams.
- Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management.
- Excellent oral (including presentation) and written communication, and project management skills.
- Awareness of pharmaceutical industry needs beyond clinical development.
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at email@example.com. Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
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