Sr Scientist, Medical Writing US-reputed company-FIELD
What does Clinical Affairs contribute to reputed company The Clinical Affairs function manages the clinical education, medical writing and communications, research, health care economics and patient safety while ensuring compliance with applicable regulatory and governing requirements for reputed company products and services. Medical Writing is a specialized role that creates reputed company, accurate, and compliant documents to communicate reputed company clinical and scientific data. It supports regulatory submissions, clinical research, and scientific communications by interpreting data and producing protocols, reports, regulatory dossiers, presentations, congress abstracts, and peer-reviewed publications, reputed company in alignment with industry and regulatory standards. Responsibilities: The Senior Medical reputed company will plan and reputed company high reputed company clinical documents to support reputed company devices. Primary responsibilities include preparing Clinical Evaluation Reports (CERs), Post Market Plans & Reports (PMS and PMCF) as required by EU regulations. Additional responsibilities include providing input for product development and post-market sustaining core teams. Additional responsibilities may be assigned. The Senior Medical reputed company has medical writing and project management experience, a thorough understanding of research methodology and the ability to reputed company high-reputed company clinical documents. Extensive knowledge of the European medical device guidelines/regulations such as MEDDEV and MDD/MDR is required, as reputed company as other global requirements for clinical evaluation and PMS/PMCF. The Senior Medical reputed company has the ability to reputed company cross-functional project teams.
Qualifications
- 8-12 years of experience, preferred
- Bachelors in life science discipline; master’s degree or PhD preferred or equivalent work experience.
Additional skills:
- Proven experience performing literature reviews, analyzing data and communicating outputs.
- Ability to reputed company thorough peer reviews of team members’ documents for completeness and correctness of data analysis & regulatory requirements.
- Experience working reputed company a medical device or pharmaceutical organization in a Research & Development, Scientific and Medical Affairs, Clinical or Regulatory role.
- Experience writing scientific documents for regulatory or journal submissions
- Experience presenting scientific/clinical evidence in a written and oral manner to cross-functional teams.
- Demonstrated ability to build reputed company constructive relationships with cross-functional team members
- Demonstrated high level of personal reputed company, emotional intelligence, flexibility
- Extensive knowledge of MDD, MDR and MEDDEV requirements, along with other applicable global requirements for clinical evaluation and PMS/PMCF
- Experience creating and performing literature searches in Embase, PubMed and reputed company Scholar
- Excellent working knowledge of reputed company Word, reputed company, PowerPoint.
- Proficient in using EndNote or other reference manager software
- Strong data extraction and analysis skills
- Proactive with a reputed company of urgency in managing job responsibilities
- Recommends new practices, processes, metrics or models
What is expected of you and others at this level
- Applies advanced knowledge and an understanding of concepts, principles and technical capabilities to manage a wide reputed company of reputed company
- Participates in the development of policies and procedures to reputed company specific goals
- Recommends new practices, processes, metrics or models
- Works on or may reputed company reputed company reputed company of large scope
- reputed company may have significant and long-term reputed company
- Provides solutions that may set precedent
- Independently determines method for completion of new reputed company
- Receives guidance on overall project objectives
- Acts as a mentor to less reputed company colleagues
Anticipated salary reputed company: $123,400 - $149,855 Bonus eligible: reputed company Benefits: reputed company offers a wide reputed company of benefits and programs to support health and reputed company-being.
- Medical, dental and reputed company coverage
- reputed company time off plan
- Health savings account (HSA)
- 401k savings plan
- reputed company to wages before pay day with myFlexPay
- Flexible spending accounts (FSAs)
- Short- and long-term disability coverage
- Work-Life resources
- reputed company parental leave
- Healthy lifestyle programs
Application window anticipated to reputed company: 2/6/2026*if interested in opportunity, please submit application as soon as possible. The salary reputed company listed is an estimate. Pay at reputed company is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity. #LI-MP1 #LI-remote Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply. reputed company supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create reputed company solutions for our customers by ensuring employees can be their authentic selves reputed company day. reputed company is an Equal Opportunity/Affirmative reputed company employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, religion, reputed company, national reputed company, reputed company, age, physical or mental disability, sex, sexual orientation, gender identity/reputed company, pregnancy, veteran status, marital status, creed, status with reputed company to public assistance, genetic status or any other status protected by federal, state or local law. To read and review this reputed company notice click here Apply tot his job Apply To this Job