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SalaryJob Purpose
The Manager, Medical and Scientific Writer is responsible for authoring and subsequent maintenance of technical documentation related to the development of Ocugen’s product portfolio.
Duties and responsibilities
- Providing research and writing support to assigned scientific manuscripts, clinical protocols, clinical study report, preclinical and Scientific reports; and ad hoc written materials as requested by partners, stakeholders, and leadership.
- Producing slide presentations, executive meeting summaries, web-based and social media materials, content for digital assets, video scripts, podcasts, and other promotional medical communication materials.
- Researching updates from clinical, pharmaceutical, and biotech industries to inform and advise content and business development teams.
- Maintains writing compliance with applicable guidelines; Ability to complete documents according to sponsor's format, processes, and according to regulatory guidelines.
- Able to lead program-level or submission writing teams with general supervision.
- Responsible for establishing document timelines and strategies in accordance with internal processes, with minimal guidance.
- Prepare and finalize clinical documents such as, but not limited to, clinical study reports, investigator's brochures, SOPs, study protocols, summary documents, risk management plans, regulatory responses, and briefing documents.
- Advanced scientific degree (PhD, PharmD, or Master’s degree in Life sciences) with previous medical writing experience.
- Demonstrate exceptional written, analytical, and verbal communication skills, with extensive knowledge of English grammar and AMA standard style guides.
- Advanced knowledge of scientific and clinical research, pharmaceutical product development, varied therapeutic areas and statistical concepts.
- Interpret and communicate scientific/medical information in a clear and concise manner.
- Be flexible and independent while working in a fast-paced environment.
- Understand content strategies and trends that will guide engagement.
- Possess strong organizational skills and the ability to prioritize.
- Microsoft Office Suite experience required including Microsoft Word, Excel, and Outlook
- Must be flexible and adaptable to changing project priorities and work assignments.
- Must have strong interpersonal skills, be a team player, be able to self-advocate and willing to work in an environment where individual initiative and accountability are required.
- Careful attention to detail and quality are essential.
Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past,
current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.
