Syner-G BioPharma Group is an organization with roots to the Greater Boston area started by industry leaders in 2007 who saw a niche in the pharmaceutical consulting space and leveraged their subject matter expertise and industry knowledge to grow an organization through hard work, trusted relationships, a collaborative approach, and delivering best-in-class client services, growing the company and geographical footprint across the globe to be an industry leader in integrated biopharma consulting services across the CMC, Regulatory Affairs and Medical Writing verticals supporting small molecule, biologics and medical device development and delivery.
Job Title: Medical Writing Fellow
Location: Research Triangle Park, North Carolina
Education:
An advanced degree (e.g., MS, PharmD, PhD, or MD) in life or health science is required.
An individual with an undergraduate degree in life or health sciences who has significant writing experience may also be considered.
Technical Experience:
Ability to analyze and interpret scientific data and exhibit sound technical skills.
Ability to learn, interpret, and follow Company and Sponsor policies and procedures, including SOPs and regulatory agency regulations.
Willingness to learn medical, pharmaceutical, and clinical research concepts.
Strong computer proficiency in the use of the MS Office Suite (Word, Outlook, PowerPoint, and Excel).
Knowledge, Skills, and Abilities:
- Outstanding professional demeanor, discretion, and flexibility.
- Strong attention to detail, ensuring accuracy and quality in the performance of all duties.
- Skilled communicator, both written and verbal, who is able to present ideas and critical information to clients and internal team members effectively.
- Strong knowledge of the rules of grammar, sentence construction and paragraphing in a scientific context.
- Ability to work independently and problem solve proactively.
- Ability to work effectively within a team environment; strong collaborator and interpersonal skills.
- Strong time organizational and management skills: ability to work under pressure in a fast-paced environment, to coordinate multiple tasks concurrently, adapt to changing priorities, and to meet deadlines.
- Flexible and available to work additional hours as required.
A COVER LETTER MUST BE INCLUDED IN YOUR APPLICATION:
Your cover letter should address your ambitions, interests, abilities, what you hope to accomplish with this fellowship, and how you believe you could contribute to our organization.
ESSENTIAL FUNCTIONS:
Physical Demands:
The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.
WORK LOCATION:
The Medical Writing Fellow position is eligible for remote work based on company requirements, with no minimum in-office requirement.
JOB FUNCTIONS:
(This list is not exhaustive and may be supplemented and changed as necessary.)
Authors clinical, scientific, and regulatory submission documents with increasingly less supervision over time within a team environment according to the requirements of regulatory authorities, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice, and Syner-G (and/or Sponsor, as applicable) Standard Operating Procedures and templates. Documents include but are not limited to protocols (and amendments), clinical study reports (and amendments), subject narratives, clinical investigator brochures, and other documents as assigned.
Coordinates review (and Sponsor approval, as applicable) of clinical, scientific, and regulatory submission documents with increasingly less supervision. This process includes contributing to the development and maintenance of Sponsor-agreed upon timelines, authoring documents in a team environment, generating consensus among reviewers, facilitating discussions in an efficient manner, and preparing for, contributing to, and leading effective document-specific Sponsor meetings (i.e., roundtables).
Provides quality control services for documents written by colleagues. Quality check of documents includes data verification, consistency within a document, spelling and grammar checks, list of abbreviations and reference checks, and verification that a document is consistent with company and project-specific writing conventions and styles.
Establishes and maintains good working relationships with Sponsor representatives and colleagues.
Syner-G BioPharma Group, Syner-G BioPharma Group
