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Medical Writer Ii

2 weeks ago

Remote, India Syneos Health Clinical Full time

**Description**

**Medical Writer II**

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
**WORK HERE MATTERS EVERYWHERE**

**Why Syneos Health**
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.

**Job responsibilities**
- Works cross-functionally and collaboratively to plan and coordinate the global transparency activities (posting of protocol registration form and summary results on clinicaltrials.gov, EudraCT, and similar databases worldwide, Lay Summaries results for Patients and general public, Clinical Data Sharing, and other transparency-related activities in the EU, US and third countries) and to ensure/support compliance with procedures and to manage external communication
- Ensuring development of high-quality registration, maintenance, and results deliverables that are compliant with all applicable policies, procedures, and regulations
- Undertakes project specific activities at high quality and in defined timelines according to standard processes and operating procedures
- Systematically perform quality control checks of documents prepared by colleagues against pre-specified checklist generated in the project or SOP
- Maintain accurate and up-to-date records of individual study activities for timeline integrity, compliance, and relevant metrics tracking
- Perform detailed analyses on a planned and ad hoc basis, relating to processes and their outputs

Ensure to abide with Client process
- Completion of Internal and Client specific training

**Qualifications**

**What we’re looking for**
- Educational qualifications: A minimum of a scientific graduate degree in life sciences.
- Good knowledge of regulatory requirements or guidance pertinent to the service line.
- Good understanding of clinical development processes including principles of clinical study operations and ICH-GCP guidelines. Clear written and verbal communication skills
- Person should understand & comprehend protocol and clinical study report from disclosure perspective.
- Good understanding of clinical trial disclosure fundamental
- Core competencies for this role include ability to demonstrate:

- Analytical capabilities with scientific and clinical data.
- Professional working environment
- Ownership of the work allocated
- Commitment to highest quality outputs, including high attention to detail
- Enthusiasm and pro-activity
- Effective team working
- Ability to build rapport/ relationships with project-specific client colleague

**Get to know Syneos Health**

Over the past 5 years, we have worked with 94% of all 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 quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

**Additional Information**:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein shoul