Lead Medical Writer (Regulatory + Publications) at Syneos Health/inVentiv Health Commercial LLC

Lead Medical Writer (Regulatory + Publications) at Syneos Health/inVentiv Health Commercial LLC

DescriptionLead Medical WriterSyneos Health is a leading integrated biopharmaceutical solutions organization designed to accelerate customer success. We translate unique clinical, medical and business insights into results to address modern market realities.

Our clinical development model puts the customer and patient at the heart of everything we do. We’re constantly looking for ways to simplify and simplify our work, not only to make working with Syneos Health easier, but to make work easier for us.

Whether you join us in a functional service provider partnership or in a full-service environment, you’ll collaborate with passionate problem solvers, and innovate as a team to help our clients achieve their goals. We are agile and driven to accelerate the delivery of treatments, because we are passionate about changing lives.

Find out what our 29,000 employees in 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 interactive line management; Technical and therapeutic training in the field; Peer Recognition and Total Rewards Program.

We are committed to our culture of whole self – where you can be authentically yourself. Our whole-self culture is what unites us globally, and we are committed to taking care of our employees.

We are constantly working to build the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of ideas, backgrounds, cultures and perspectives – we are able to create a place where everyone feels they belong.

Work responsibilities*

Mentors and leads less experienced medical writers on complex projects, as necessary.*

Represents the Medical Writing Department on clinical study teams and at conferences, meetings, and client presentations in connection with the writing project.*

Advises clients and study teams on data presentation, production and data strategies to ensure client goals/expectations are met and quality standards are maintained.

Develops good working relationships with internal and external colleagues.*

Manages medical writing activities associated with individual studies, and coordinates medical writing activities within and across departments with minimal supervision.*

Develops or supports a variety of documents including but not limited to: o

Clinical study protocols and

Clinical protocol modifications;S

Clinical study reports;S

Patient narratives;o

clinical development plans; o

IND submissions and annual reports;o

Integrated summary reports;S

NDA and (e)CTD submissions;s

Investigator’s manuals, as well as;s

Clinical journal manuscripts, clinical journal abstracts, and client presentations.*

Reviews statistical analysis plans and table/figure/list specifications for appropriate content, grammar, format, and consistency.*

Serves as a peer reviewer providing review feedback to give maximum clarity in meaning, accuracy, and appropriateness and to ensure that client objectives are met and overall quality standards are maintained.*

Adheres to applicable regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company standard operating procedures, client standards, and Company and/or client approved forms when completing medical writing projects, on time and within budget.*

Conduct online clinical literature searches, as appropriate.*

Continuing professional development to keep pace with regulatory guidance and client expectations that impact medical writing and improve skills.*

Understand budget specifications for assigned projects, work within budgeted hours and communicate changes to medical writing leadership.*

Completes required administrative tasks within assigned time frames.*

Performs other work-related duties as assigned. Minimal travel may be required (less than 25%). Qualifications What we are looking for *

Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (preferably Social Sciences, English, or Communications) with relevant scientific and/or medical knowledge and experience.*

Extensive knowledge of English grammar with familiarity with the AMA Style Guide.*

An understanding of FDA and ICH regulations and guidelines is strongly preferred.*

Demonstrate effective presentation, proofreading, and interpersonal skills, ensuring a team-oriented approach.

Strong proficiency in Word, Excel, PowerPoint, email, and the Internet.*

Ability to demonstrate familiarity with the principles of clinical research and interpret and present clinical data and other complex information.

Learn about Sinus Health

Over the past five years, we have worked with 94% of all FDA-approved new drugs, 95% of EMA-approved products, more than 200 studies across 73,000 sites and more than 675,000 patients in trials.

No matter your role, you will take initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about

Sinus Health.

At Syneos Health, we believe in providing an environment and culture in which our employees can thrive, develop and advance. We reward and value our employees by providing valuable benefits and quality of life balance.

Benefits of this position may include a car or company car allowance, health benefits including medical, dental, and vision, company 401k matching, eligibility to participate in an employee stock purchase plan, eligibility to earn commissions/bonuses based on company and individual performance, and flexible paid time off (PTO). ) and sick time.

Because some states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all federal, state, and municipal paid sick time requirements.

The annual base salary for this position ranges from $85,500 to $175,700. The base salary range represents the lower and higher expected range of Syneos Health for this position.

Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies and competency in the role.

Additional Information: The tasks, duties and responsibilities mentioned in this job description are not exhaustive.

The Company may, in its sole discretion and without prior notice, assign other job tasks, duties and responsibilities.

Equivalent experience, skills and/or education will also be taken into consideration, so qualifications of incumbents may differ from those listed in the job description.

The Company will determine, in its sole discretion, what constitutes equivalent to the qualifications described above.

Furthermore, nothing contained herein should be construed as creating a contract of employment.

Sometimes, the skills/experience required for jobs are expressed in brief terms.

Any language contained herein is intended to comply fully with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

The Company is committed to complying with the Americans with Disabilities Act, including providing reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

#Lee – PM1

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