Medical Writer (Regulatory and Clinical) | North Carolina (Remote)

Medical Writer | North Carolina (Remote)

My Client is currently developing multiple vascular tissue engineered therapies and expanding their business model. With a broad pipeline of potential new therapy applications, they continue to build their organization and scientific teams. They are looking for additional colleagues to continue to build their expanding team.

Position Background

To author complex regulatory, clinical and safety documents ensuring the coordination and integration of the scientific, medical and regulatory input from development team members. To support the performance goals (including quality and timeliness) for filing worldwide regulatory dossiers as planned by the Development Teams.

Position reports to VP, Clinical

Primary Responsibilities

·      Ensures that all assigned documents support the full development strategy to achieve target labeling objectives and timely approvals in key markets

·      Participates in relevant clinical team, regulatory team or commercial team discussions and ensures effective planning and management of timelines for all components of assigned documents

·      Participates and/or leads document prototyping sessions including the design of data displays, document flow, logic and consistency for assigned project prototypes; critically reviews project specific model documents, maintains document prototypes/shell reports

·      Documents and implements consensus at meetings of determined data interpretation and key findings/messages

·      Authors complex clinical documents (e.g. protocols, clinical study reports, high level summary documents), and certain non-clinical documents (e.g. initial Investigator’s Brochure, updates for scientific journals, other publications) for timely submission to health authorities, editors or other required entities

·      Reports on compliance related issues to senior leadership as required

·      Other duties, as assigned

General Competencies

·      Possess a positive attitude and optimistic outlook

·      Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others

·      Excellent organizational and time management skills with ability to set own priorities in a timely manner

·      High degree of flexibility and adaptability

·      Strong communication (verbal and written) and organizational skills

·      Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook

·      Detail-oriented, self-motivated and scientifically driven

·      Motivated and organized critical thinker with solid interpersonal and communication skills

·      Strong analytical and problem-solving skills

·      Demonstrated ability to work in a cross functional team

·      Routinely communicate findings and information to other team members; transparency and knowledge sharing is expected and practiced

·      Must be able to work as needed to meet tight deadlines and at peak periods

Special Competencies

·      Excellent written and oral communication skills

·      Demonstrate strong critical thinking skills with the ability to motivate others

·      Ability to work effectively within a team to set goals, write technical and validation reports, resolve compliance issues in scientific and industry-standard terms, as required

·      Routinely communicate findings and information to peers and other team members; transparency and knowledge sharing is expected and practiced

·      Proficient with Microsoft Word, Excel, PowerPoint and Visio, preferred

·      Proficiency in image processing programs preferred

·      Proficiency in bibliographic and e-publishing programs preferred

·      Capable of writing management level reports and summaries

·      Strong problem solving and analytical skills

·      Detailed oriented, self-motivated and scientifically driven

·      Demonstrated ability to work in a cross functional team

·      Excellent communication and interpersonal skills

·      Proactively investigate and resolve discrepancies

·      Ability to resolve issues quality system issues, related to deviations, non-conformances change controls etc.

·      Clearly communicates issues with co-workers and supervision and communicates in a timely manner

Qualifications

·      MS/BS in sciences or engineering or healthcare field, with a minimum of 3 years (MS) to 5 years (BS) of experience in regulatory, safety or pharmacovigilance documentation

·      Excellent demonstrable understanding of ICMJE and GPP guidelines and regulations required

·      Ability to read, analyze, and interpret common scientific and technical journals

·      Ability to write presentations and articles for peer reviewed publications that conform to prescribed style and format

·      Must demonstrate an outstanding command of the English language (read, write and speak). Experience with clinical and medical language a plus

·      Ability to work with mathematical concepts such as probability and statistical inference

·      Strong understanding of cGMP, ISO and ICH guidance’s in the biotech/life sciences environment

Connect:

If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.

Medella Life

As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything we do.