Sr. Medical Company Confidential (Regulatory)

Sr. Medical Company Confidential (Regulatory) Company Confidential® is a leading fully-integrated life sciences services organization Company Confidential to accelerate Company Confidential. We partner with innovators at every Company Confidential across the drug development and commercialization Company Confidential, helping them Company Confidential complexity, anticipate change and accelerate Company Confidential. Our Company Confidential Solutions team members Company Confidential with a drug development Company Confidential, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we Company Confidential. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as Company Confidential to help our customers Company Confidential their goals. We are Company Confidential and driven to Company Confidential – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 Company Confidential colleagues already know Why Company Confidential We are passionate about developing our people, through career development and progression; supportive and Company Confidential line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Company Confidential – which captures the passion of our colleagues to show up Company Confidential day and Company Confidential solutions that have the ability to dramatically Company Confidential someone’s life. • We are continuously building Company Confidential we Company Confidential want to work for and our customers want to work with. Why? Because we know that Company Confidential we bring together smart colleagues from across the world, we can Company Confidential the Company Confidential of Company Confidential, driving Company Confidential for customers and defining the Company Confidential of Company Confidential Company Confidential. Job Responsibilities Leads the Company Confidential and accurate completion of medical writing deliverables, ensuring scientific information is presented Company Confidential and accurately. Manages medical writing activities associated with individual studies, coordinating medical writing activities Company Confidential and across departments with Company Confidential supervision. Leads the Company Confidential of comments from the Company Confidential. Completes a Company Confidential of documents that may include Company Confidential study protocols and Company Confidential study protocol amendments; Company Confidential study reports; Company Confidential narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports, Company Confidential development plans; IND submissions; integrated Company Confidential reports; NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific meetings. Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as Company Confidential as company Company Confidential operating procedures, Company Confidential standards, and company and/or Company Confidential approved-templates, authorship requirements, and style and formatting guides, Company Confidential completing medical writing Company Confidential, on time and on budget. Coordinates Company Confidential and editorial reviews. Ensures Company Confidential documentation is managed appropriately. Leads team document reviews, and reviews documents as needed. Acts as peer reviewer for internal team to ensure document scientific content, Company Confidential, overall consistency, and Company Confidential format. Reviews statistical analysis plans and table/Company Confidential/listing specifications for appropriate content, and for grammar, format, and consistency. Provides feedback to Company Confidential define statistical Company Confidential required and document needs. Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables. Performs online Company Confidential literature searches and complies with copyright requirements. Identifies and proposes solutions to Company Confidential issues, escalating as appropriate. Provides technical support, training, and consultation to department and other company staff. May contribute to development of internal materials and presentations or changes to internal Company Confidential, Company Confidential practices, and capabilities. Mentors and leads less Company Confidential medical writers on Company Confidential Company Confidential, as necessary. Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that Company Confidential medical writing. Company Confidential of budget specifications for assigned Company Confidential, working Company Confidential the budgeted hours and communicating status and changes to medical writing leadership. Completes required administrative tasks Company Confidential the specified timeframes. Performs other work-Company Confidential duties as assigned. Company Confidential travel may be required (less than 25%). At Company Confidential, we Company Confidential in providing an environment and culture in which Our People can Company Confidential, Company Confidential and advance. We reward and recognize our people by providing valuable benefits and a Company Confidential-of-life Company Confidential. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Company Confidential, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus Company Confidential on company and individual Company Confidential, and flexible Company Confidential time off (PTO) and Company Confidential time. Because certain states and municipalities have regulated Company Confidential Company Confidential time requirements, eligibility for Company Confidential Company Confidential time may vary depending on where you work. Syneos complies with Company Confidential applicable federal, state, and municipal Company Confidential Company Confidential time requirements. Salary Company Confidential $80,600.00 - $175,700.00 The Company Confidential salary Company Confidential represents the anticipated low and high of the Company Confidential Company Confidential for this position. Actual salary will vary Company Confidential on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know Company Confidential Over the past 5 years, we have worked with 94% of Company Confidential Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status Company Confidential with us in a highly competitive and Company Confidential-changing environment. Learn more about Company Confidential. Additional Information Tasks, duties, and responsibilities as listed in this Company Confidential are not exhaustive. Company Confidential, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will Company Confidential be considered so qualifications of incumbents may differ from those listed in the Company Confidential. Company Confidential, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Company Confidential, Company Confidential contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully Company Confidential with Company Confidential obligations imposed by the legislation of Company Confidential country in which it operates, including the implementation of the EU Equality Company Confidential, in relation to the recruitment and employment of its employees. Company Confidential is committed to compliance with the Americans with Company Confidential, including the provision of reasonable accommodations, Company Confidential appropriate, to assist employees or applicants to Company Confidential the essential functions of the job. Originally posted on Himalayas Apply To This Job