Technical Reviewer / Scientific Expert (MLR) Barcelona, Spain. Sponsor dedicated.

Technical Reviewer / Scientific Expert (MLR) Barcelona, Spain. Sponsor dedicated.

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.  

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

Accountabilities

• Perform thorough data quality check of promotional, non-promotional, and scientific/medical communication MLR Assets; ensuring all content is scientifically accurate and appropriately supported by the required Reference Document. 
• Reference check of promotional, non-promotional, and scientific/medical communication MLR assets, ensuring all Reference Documents used to support the asset are up to date and appropriate according to Client's Guidelines. 
• Adjust and modify MLR asset content to ensure scientific accuracy, best usage of Reference Documents and compliance in regards to branding, style, grammar and regulations (if appropriate). 
• Manage medical and regulatory reviewers' comments and perform the necessary changes required for the MLR review approval of assets. If appropriate, contact MLR Process Manager/Content Owner to send asset back to Agency to complete required changes by MLR reviewer comments. Perform quality check of assets after Agency changes.
• Check, detail and add all anchors required to support the MLR asset. Ensure all the information is included in the MLR platform (Veeva Vault) and available to MLR reviewers. 
• Identify assets or parts of assets that require pre-alignment with the required MLR reviewers. Flag any assets, asset areas or sentences that are non-substantiated, difficult to substantiate, or do not follow local regulations, as appropriate.

Job Expertise

• Extensive experience in medical/scientific writing tasks.
• Keen attention to detail and deep understanding of scientific content requirements.
• Confidence in using subject matter expertise.
• Ability to self-start and manage multiple projects simultaneously.

Minimum Education/Degree Requirements

• Experienced Medical/Scientific Writer (3-5 years), with a scientific background and degree (PharmD, MD, PhD or Masters), at least 3 years producing scientific content as a writer, with knowledge of IT and digital solutions.

Required Capabilities (Skills, Experience, Competencies)

• Excellent medical writing skills.
• Proven experience in scientific literature databases and review procedures.
• Strong attention to detail and accuracy, ability to manage and prioritize multiple, detailed activities, results-orientated with fast and focused execution.
• Good communication, coordination and time management skills.
• Ability to work within a team or across multiple teams (including remotely) as well as independently.
• Fluent in oral and written English with high level of communication skills.
• Fluent in one or more of the target markets' languages: Spanish, German.
• Values teamwork and collaboration, diversity and inclusion, and innovation.
• Prior experience working in Content creation for Biotech/Pharma, either within an Agency or as a Content Owner, would be advantageous.
• Prior experience working in any of the therapeutic areas of Metabolism, Cardiovascular or Nephrology would be advantageous.
• Prior experience with the MLR Review process would be advantageous. 
• User knowledge of the MLR Review platform Veeva Vault would be advantageous. 
• Experience in the process of Anchoring/Linking assets in Veeva Vault would be advantageous.

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.

http://www.syneoshealth.com

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 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 comply 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 compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.